NASDAQ: QTRX

We sell our proprietary instruments and related consumables worldwide to research laboratories, contract research organizations ("CROs"), academic institutions, and bio-pharmaceutical companies. In addition, we provide contract research services and clinical laboratory testing services, including four Laboratory Developed Tests ("LDTs"), using our proprietary technology and platforms through our Accelerator Laboratory, which is certified under the Clinical Laboratory Improvement Amendments of 1988 ("CLIA"), located in Bedford, Massachusetts (the "Accelerator Laboratory").

Recent Developments

Recent Board of Directors and Management Transitions

In the second half of 2025, four new directors joined our board of directors and four previous members of our board of directors departed, including Dr. David Walt, our founding scientist. Additionally, in January 2026 Dr. Masoud Toloue left the company, and Everett Cunningham became our Chief Executive Officer and joined our board of directors. The selection process for these new board members and our CEO reflects a deliberate enhancement of technology, commercial, spatial, and diagnostics expertise across our leadership and board of directors.

Acquisition of Akoya Biosciences, Inc.

On July 8, 2025, we acquired Akoya Biosciences, Inc. ("Akoya"), a life sciences technology company based in Marlborough, Massachusetts delivering spatial biology solutions through the power of spatial phenotyping. Spatial phenotyping refers to a rapidly evolving technology that enables scientists to detect and map the distribution of cell types and biomarkers across whole tissue samples at single-cell resolution, enabling advancements in their understanding of disease progression and patient response to therapy. Akoya commercializes proprietary instrument platforms, reagents, software, and services that offer end-to-end solutions to perform tissue analysis and spatial phenotyping from discovery through translational and clinical research and diagnostics.

Acquisition of Emission, Inc.

On January 8, 2025, we acquired Emission, Inc. ("Emission"), a life sciences manufacturing company based in Georgetown, Texas. Emission produces large-scale, highly-uniform dye-encapsulating magnetic beads designed for low and mid-plex assays and a mid-plex platform that reads its proprietary beads. The transaction secured the use of Emission’s highly controlled beads in our next generation platforms and expansion into a new multi-plex segment targeting third-party original equipment manufacturer customers.

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For further information about the Akoya and Emission acquisitions, refer to Note 3 - Acquisitions in the Notes to Consolidated Financial Statements for the year ended December 31, 2025 included in the section titled, "Part II, Item 8. Financial Statements and Supplemental Data" of this Annual Report on Form 10-K.

FDA 510(k) Submission for a Multi-Analyte Algorithmic Blood Test for Alzheimer’s Disease Detection

On January 31, 2026, we submitted a 510(k) premarket notification to the U.S. Food and Drug Administration ("FDA") for our multi-analyte algorithmic blood test for Alzheimer’s disease ("AD").

This submission represents a significant milestone in the Company’s mission to provide superior, non-invasive, high-performance diagnostic tools to aid in the evaluation of patients with cognitive symptoms for possible Alzheimer’s disease. Our multi-analyte test previously received Breakthrough Device Designation from the FDA, a program intended to accelerate the development and review of devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. Our test, if cleared by the FDA, is intended to aid in identifying whether patients with cognitive symptoms are likely to have amyloid brain plaques—a hallmark of Alzheimer’s disease —providing diagnostic clarity through a non-invasive blood test.

LucentAD Complete Medicare Pricing

In November 2025, the Centers for Medicare & Medicaid Services ("CMS") approved a reimbursement rate of $897 for our LucentAD Complete multiplex test. This milestone provides a nationally recognized reference price, an important step for coverage decisions with payers, enables broader access. and supports efforts to bring this multiplex diagnostic solution to hospitals and laboratories across the country. In addition, based on available data, we believe LucentAD Complete has the potential to obtain a Local Coverage Determination, which would support more consistent reimbursement of claims.

Cooperation Agreement with Kent Lake Partners

As previously disclosed, on August 4, 2025, we entered into a Cooperation Agreement (the "Cooperation Agreement") with Kent Lake PR LLC, the general partner of Kent Lake Partners LP (together, "Kent Lake"), pursuant to which we agreed to retain an executive search firm to identify a potential candidate to be appointed to our board of directors (the "Board"). We also agreed to cooperate with Kent Lake to select an individual from the executive search firm’s list of six candidates and to appoint such person as a Class I director by December 1, 2025. On November 20, 2025, the Board appointed two new directors, including one new Class I director.

Also pursuant to the Cooperation Agreement, we sought and obtained stockholder approval at our 2025 annual meeting of stockholders of an amendment to our Amended and Restated Certificate of Incorporation that declassified the Board, and we amended our bylaws to adopt a majority voting standard for uncontested director elections, with a plurality voting standard for contested director elections.

In the Cooperation Agreement, Kent Lake agreed to abide by certain voting commitments, customary standstill obligations and mutual non-disparagement, and no litigation provisions until the date that is thirty days prior to the nomination deadline under the bylaws for the nomination of director candidates for election to the Board at the 2027 annual meeting of stockholders, unless the Cooperation Agreement is earlier terminated in accordance with its terms.

Industry Background

Proteins are versatile macromolecules that serve critical functions in nearly all biological processes. Proteins are analytes that are highly relevant physiologically, providing real-time pictures of disease, and researchers and clinicians rely extensively on protein biomarkers for use in research and as clinical and diagnostic tools. However, normal physiological levels of many proteins are not detectable in easily accessible blood samples using conventional, analog immunoassay technologies, and many of these technologies can only detect proteins once they have reached levels that reflect more advanced disease or injury. For many other low abundance proteins, these technologies cannot detect proteins even at disease- or injury-elevated levels.

Enzyme-linked immunosorbent assay ("ELISA") technology has been the most widely used method of sensitive detection of proteins for more than 50 years. In simple terms, ELISA involves using a plate coated with an antibody that binds to the target molecule. If the target is present in the sample, it attaches to the plate via the antibody. Then, a second

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molecule, often an enzyme-linked antibody, is added, binding to the target. The enzyme produces a detectable signal (like fluorescence or a color change) when a specific substrate is added, indicating the presence and quantity of the target molecule in the sample. Although ELISA is widely used in medical diagnostics and research, it has very significant limitations, including limited sensitivity and narrow dynamic range (i.e., the range of concentration of proteins being detected). Efforts to increase the sensitivity of conventional ELISA have had limited success due to procedural complexity and length.

Immunohistochemistry ("IHC") is the traditional technique used for detecting and localizing antibody protein markers in tissue samples. This microscopy application allows clinicians and scientists to visualize target antigens within tissue slides helping to understand their location and distribution to help diagnose cancer or tumor types. The application generates fluorescent signals through the use of antibodies linked to a fluorophore or secondary antibody carrying a detectable enzyme or dye. Our Spatial Biology platforms have advanced this concept to a highly multiplexed capability enabling a 2D/3D functional view of tissue and biomarkers. Detecting multiple biomarkers with this technology now enables significantly more detail to be extracted from the same tissue sample for better precision and understanding in the tissue microenvironment.

Spatial proteomics and fluid-based biomarker analysis both continue to evolve and expand their use case from core research markets to clinical applications. Quanterix believes that the combination of insights gained from the use of our instrumentation will drive innovation and application expansion supporting clinical decision making into the future.

Our Technologies

Simoa Technology

Our Simoa bead-based and planar array technologies are based on traditional ELISA technology but significantly advance conventional ELISA technology and are capable of substantially greater protein detection sensitivity. We believe that our Simoa platforms are among the most sensitive commercially available multiplex protein detection platforms.

Simoa Bead-Based Technology

Simoa bead-based digital immunoassays utilize the basic principles of conventional bead-based sandwich ELISA. However, unlike ELISA, which runs the enzyme-substrate reaction on all molecules in one well, Simoa bead-based reactions are run on individual molecules in tiny microwells, 40 trillionths of a milliliter, that are 2.5 billion times smaller than traditional ELISA wells. In traditional analog ELISA measurements, the detected signal increases in intensity as the concentration of a sample increases. In Simoa bead-based digital technology measurements, however, the detected signal relies on a binary signal/no signal readout, enabling single molecule detection, and analytical sensitivity in the femtomolar range compared with nanomolar and picomolar levels of detection in conventional ELISA.

HD-X

Our HD-X is our flagship instrument that empowers biomarker research and accelerates drug development. It is a fully automated immunoassay platform with multiplexing and custom assay capability designed to deliver significant productivity and operational efficiency improvements, as well as greater user flexibility. The HD-X is based on our bead-based technology, and assays run on the HD-X are fully automated.

SR-X

Our SR-X instrument is a compact benchtop instrument with a lower price point, more flexible assay preparation, and a wider range of applications. The SR-X utilizes the same Simoa bead-based technology and assay kits as the HD-X. In contrast to the fully automated workflow of the HD-X, the assay incubation and washing steps for the SR-X are performed outside of the instrument using conventional liquid handling methods. The offline sample prep provides additional flexibility to enable researchers to apply Simoa detection in an expanded range of applications.

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Simoa Planar Array Technology

Simoa planar array immunoassays utilize the basic principles of conventional microplate-based sandwich ELISA. However, unlike ELISA, which runs the enzyme-substrate reaction on all molecules coating the entire bottom surface in one well, Simoa planar array reactions are run on spatially segregated micro-spots within the bottom of microtiter plate wells that concentrate the signal to a surface area 1,000 times smaller than a traditional ELISA. The small spot size and spatial segregation of each spot enables multiplexing up to 12 different assays within a single sample well.

SP-X

Our SP-X uses Simoa planar array technology for multiplex chemiluminescent immunoassay measurement with sensitivity similar to that found in our Simoa bead-based platforms.

Simoa Assays and Consumables

Recurring revenue is derived through the sale of consumables used to run assays on our instruments and from our growing menu of Simoa digital biomarker assays. The current menu of approximately 65 analyte-specific single-plex and multi-plex assay kits for our bead-based instruments includes assays for biomarkers in the areas of neurology, infectious disease, immunology and oncology for both human and mouse samples. The current menu of assay kits for the planar array instrument includes approximately 45 biomarkers ranging from 1-10 analytes per assay in the areas of immunology, and oncology research.

In addition to the assays we have developed, the Simoa platforms allow ease and flexibility in assay design, enabling our customers to develop their own proprietary in-house assays, which we refer to as "homebrew" assays, using our homebrew assay kits. These kits include all components required for customers to run tests using their own antibodies. Our consumables portfolio for our bead-based platform also includes our proprietary Simoa disks that are unique to our bead-based platform, as well as cuvettes and disposable tips.

Spatial Technology

Our Spatial Biology solutions measure protein expression and cellular phenotypes within intact tissue while preserving spatial context and tissue architecture. By enabling the simultaneous detection of multiple biomarkers at single-cell resolution across whole tissue sections, our platforms provide quantitative insights into cellular composition, organization, and interactions within complex biological systems.

Conventional genomic and proteomic techniques, including next-generation sequencing ("NGS"), single-cell analysis, flow cytometry, and mass spectrometry, generate valuable molecular data but generally require tissue dissociation or destruction. As a result, these methods do not preserve spatial relationships between cells or localized biomarker expression within the native tissue environment. Traditional histological and non-destructive tissue analysis methods preserve tissue structure but are typically limited to measuring a small number of biomarkers per sample and often rely on qualitative interpretation by trained pathologists.

Our Spatial Biology platforms are designed to address these limitations by enabling end-to-end spatial phenotyping, allowing researchers to quantitatively analyze large numbers of protein biomarkers and cell types across intact tissue sections at single-cell resolution. The resulting data generate high-dimensional, spatially resolved maps that characterize tissue architecture, cellular heterogeneity, and biomarker co-localization, supporting the study of tissue dynamics and cell–cell interactions.

Our Spatial Biology technology platform integrates proprietary imaging hardware, scalable multiplexing enabled by barcoded antibody chemistry and classic Opal™ chemistry, and curated biomarker panels designed for standardized implementation. Together, these components support reproducible, whole-slide imaging and the generation of structured, computationally analyzable datasets.

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We believe our platform capabilities support applications across the research continuum, from exploratory and discovery-stage research through translational and clinical research settings. These capabilities are intended to enable customers to advance the understanding of human biology, disease mechanisms, and therapeutic response, and to support the progression of spatial biology insights into downstream research and clinical workflows.

Spatial Biology Instruments

PhenoCycler & PhenoImager Fusion

Our PhenoCycler and PhenoImager Fusion instrument modules operate in a coordinated manner and provide the customer with a complete system for performing high-quality, high-plex tissue biomarker measurements.

Our PhenoCycler employs a barcoded antibody-based chemistry designed to enable highly multiplexed protein detection through cyclic signal readout rather than sequential antibody staining. In this workflow, all antibodies in a panel are applied to the tissue simultaneously in a single staining step. Each antibody is conjugated to a unique oligonucleotide barcode that serves as a molecular identifier for its target protein.

Following antibody binding, signal detection is achieved through iterative cycles of oligonucleotide hybridization and dehybridization. In each cycle, a defined set of fluorescently labeled reporter oligonucleotides—each complementary (antisense) to a subset of the antibody barcodes—are introduced together with a nuclear counterstain. Each cycle enables detection of multiple protein targets through reporter hybridization, while the nuclear stain provides consistent spatial reference across cycles.

After reporter hybridization, the tissue is imaged using the PhenoImager Fusion to capture spatially resolved signal from the bound reporters. The reporter oligonucleotides are then removed through controlled dehybridization, enabling subsequent cycles of reporter hybridization and imaging on the same tissue section. This process allows repeated signal acquisition without repeated antibody staining or tissue stripping.

This cyclic hybridization, imaging, and dehybridization approach enables multiplexed detection of protein biomarkers while preserving tissue integrity and spatial context. The cycling steps are automated through the PhenoCycler fluidics system and are designed to operate in conjunction with the PhenoImager Fusion imaging platform, which performs whole-slide imaging following each reporter hybridization cycle.

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PhenoImager HT

Our PhenoImager HT is a whole-slide imaging platform designed to support multiplexed tissue imaging using single-round staining and imaging workflows. The system enables one-shot detection of multiple protein biomarkers within a single imaging acquisition, typically supporting low- to mid-plex immunofluorescence and brightfield assays while preserving tissue morphology and spatial context.

PhenoImager HT is designed to image formalin-fixed paraffin-embedded ("FFPE") and fresh frozen tissue sections and tissue microarrays. The platform supports both fluorescence and chromogenic detection methods and is compatible with established IHC and immunofluorescence workflows commonly used in translational research and clinical laboratory environments.

Unlike cyclic imaging approaches, PhenoImager HT performs multiplexed imaging in a single imaging step, enabling streamlined workflows and reduced assay complexity. This one-shot imaging approach is intended to support applications where moderate levels of multiplexing are sufficient and where workflow simplicity, reproducibility, and compatibility with existing laboratory practices are important considerations.

Image data generated by PhenoImager HT are processed into our proprietary QPTIFF file format, as well as additional standard image formats, to support downstream analysis using our software solutions and third-party image analysis platforms. The system is commonly used in translational research, biomarker validation, and LDT workflows, and has historically supported applications bridging discovery research and clinical investigation.

Spatial Biology Assays

Our Spatial Biology assays are based primarily on proprietary barcoding chemistry designed to support multiplexed protein detection in spatial biology applications. This chemistry utilizes barcoded antibodies in combination with cyclic signal detection workflows, enabling multiplexed analysis of protein expression while preserving tissue architecture and spatial context. These assays are designed for use across our Spatial Biology platforms, including PhenoCycler, PhenoImager Fusion, and PhenoImager HT, depending on the assay format and level of multiplexing required.

We offer a portfolio of ready-to-use, preconfigured antibody panels under our PhenoCode brand. For the PhenoCycler platform, these include curated discovery panels designed for high-plex spatial phenotyping applications, such as the PhenoCode IO60 panel, Mouse IO panel, Human Neuro panel, and Mouse Neuro panel. These panels are designed to support standardized implementation of multiplexed spatial assays and are intended to reduce assay development complexity for customers.

For our PhenoImager platforms, we offer PhenoCode Signature Panels, which are designed for single-round, low- to mid-plex imaging workflows. These panels are intended to support translational research, biomarker validation, and clinical research workflows where streamlined assay execution and reproducibility are important considerations.

In addition to ready-to-use panels, we sell a broad range of reagents on an à la carte basis, including barcoded antibodies, reporters, buffers, and ancillary reagents. These offerings allow customers to design and optimize custom panels and workflows tailored to specific research objectives and experimental requirements. This modular reagent approach is intended to support flexibility across discovery, translational, and applied research use cases.

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We also support Opal ‘classic’ chemistry, an immunofluorescence method based on unconjugated primary antibodies, secondary antibodies conjugated to polymer HRP, and a suite of TSA-conjugated fluorophores. Opal chemistry protocols for multiplexed measurements can be automated on industry-standard autostainers. The signal amplification provides enhanced sensitivity. Opal chemistry is compatible with standalone PhenoImager Fusion and PhenoImager HT systems. This chemistry is commonly used in established immunohistochemistry and immunofluorescence workflows and provides continuity for customers with existing assay investments.

Services

Through our CLIA-certified Accelerator Laboratory, we provide research customers contract research services and we provide medical providers clinical laboratory testing services. The Accelerator Laboratory supports multiple projects and services, including:

•Research and Clinical Trial Testing: Utilizing either our commercially available reagent kits, or customer specific custom assays, our Accelerator Laboratory provides customers access to our Simoa and Spatial Biology platforms by running studies ranging from thousands of specimens to small de novo experiments with just a few samples. Partnering with clients to address critical needs on sample volume, custom assay development, and unique study designs, we support a broad range of programs from large scale clinical trial data generation to research focused cohorts supporting discovery, validation, and clinical testing of predictive biomarkers in translational research and enabling patient stratification and selection in clinical studies.

•Lucent Diagnostics: In July 2023, we launched Lucent Diagnostics, a suite of clinical laboratory testing services for neurology healthcare providers, initially focused on Alzheimer’s disease. To support a streamlined provider workflow, Lucent Diagnostics includes a web portal where healthcare providers can order sample collection materials, order a test, track the status of a test, and retrieve the test report. The process for testing involves a healthcare provider drawing a blood sample from an individual and shipping the sample to our Accelerator Laboratory to analyze the sample and communicate the result back to the provider. Healthcare providers can currently order the following tests through Lucent Diagnostics:

1.LucentAD p-Tau 181: an LDT to quantitatively measure p-Tau 181 in plasma as an aid in diagnosis of Alzheimer’s disease.

2.Simoa NfL LDT: an LDT to quantitatively measure neurofilament light chain ("NfL") in serum as an aid in the evaluation of individuals for possible neurodegenerative conditions or other causes of neuronal or central nervous system damage.

3.LucentAD p-Tau 217: an LDT to quantitatively measure p-Tau 217 in plasma to aid in diagnosis of Alzheimer’s disease.

4.LucentAD Complete: a multi-marker (p-Tau 217, amyloid β 42 ("Aβ42"), amyloid β 40 ("Aβ40"), NfL, and glial fibrillary acidic protein ("GFAP")) algorithmic LDT for high accuracy plasma detection of amyloid pathology to aid in diagnostic evaluation of patients with cognitive issues who may have Alzheimer’s disease. By using a proprietary algorithm to score five Alzheimer's disease-related biomarkers, LucentAD Complete provides significantly better amyloid classification compared to single-marker tests alone and has lowered the intermediate zone of a single-marker test from approximately 30% to 10%, while maintaining high sensitivity, specificity, and accuracy.

Extended Warranty and Service Contracts

We also generate revenues through extended-warranty and service contracts for our installed base of instruments.

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Our Strategy

Our commercial strategy is based on three core growth vectors: (i) Grow menu; (ii) Expand into adjacencies; and (iii) Translate into diagnostics. Our plans to achieve this GET strategy include:

•Growing through rapid internal menu expansion. In 2024 and 2025, we launched 20 and 11 new Simoa assays, respectively that were developed using improved protocols, manufacturing efficiencies, and reagent improvements to provide more consistent results and improved lot-to-lot consistency. In 2025, we also launched two Spatial Biology panels. We expect that the expansion of our assay menu to increase average consumable pull-through as additional assays become available for use on our existing installed base.

•Continuing to grow our leadership position in the measurement of neuro-based biomarkers. We intend to leverage the growing importance of neurological biomarkers to advance the development of therapeutics and diagnostics for neurodegenerative conditions, including Alzheimer’s disease. The importance of neurological biomarkers, such as NfL, p-Tau 181, p-Tau 217 and GFAP, has increased significantly in recent years, and our ultra-sensitive Simoa platforms have allowed research of neurological disorders, previously limited primarily to cerebrospinal fluid ("CSF"), to expand significantly.

•Expanding further into indications beyond neurology. The ability of our Simoa technology to detect and quantify low abundance proteins with exquisite sensitivity is a distinct advantage in detecting disease earlier in other indications, in particular oncology and immunology. There are over 1020 scientific publications that reference Simoa technologies in non-neurology indications. We expect to expand our Simoa product offerings into adjacencies through internal research and development investment. The acquisition of Akoya establishes us in the spatial biology market with applications across research and clinical trial settings. The acquisition diversifies our revenues by disease type, shifting from over 90% neurology to a diversified mix of approximately 60% neurology and 40% oncology. Furthermore, we believe researchers will be able to combine the capabilities of our multiplexed biomarker detection in tissue with our ultra-sensitive biomarker detection in blood to achieve new discoveries about disease onset and progression in oncology and immunology.

•Expanding our presence in diagnostics. Our ultra-sensitive Simoa platforms have enabled the development of a new category of less-invasive diagnostic tests that could replace current invasive, expensive, and inconvenient diagnostic methods, including spinal tap and diagnostic imaging. We currently offer four neurological LDTs through our Accelerator Laboratory.

•Helping to build the global infrastructure for Alzheimer’s disease testing and diagnosis. There are over 55 million people living with Alzheimer’s disease, a number that is expected to double by 2050. We believe our ultrasensitive technology can enable earlier detection. We are helping to build the global infrastructure for Alzheimer’s testing in two ways. First, we are enabling partners by providing Simoa technology to a number of the top prescribing hospital networks and reference labs globally. We entered into 13 of these partnerships in 2025 bringing the total number of partners at the end of 2025 to 25 and intend to continue to grow this network in 2026. Second, through Lucent Diagnostics, we are offering best-in-class diagnostic testing through our LucentAD Complete test, which was launched in November 2024.

Our Key Focus Areas

We have focused the application of our technologies on areas of high growth and high unmet need and where existing platforms have significant shortcomings that our technology addresses, including neurology, oncology, and immunology.

Neurology

The ability of Simoa technology to detect neurological biomarkers in blood at ultra-low levels, combined with our multiplexing capability, has significantly advanced neurology research, drug development, and diagnostics test development. Prior to the launch of our p-Tau 181 LDT for clinical use in July 2022, the brain was the only organ in the body for which there was not a blood-based diagnostic test. The challenge with developing blood-based tests for the brain is that the blood-brain barrier, which is formed by endothelial cells lining the cerebral microvasculature, is very tight and severely restricts the movement of proteins and other substances between these endothelial cells and into blood circulation. Accordingly, diagnosis of brain disease and injury has traditionally required either brain imaging or a spinal tap to collect

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CSF. The sensitivity of Simoa technology has enabled researchers to discover that extremely small amounts of critical neural biomarkers diffuse through the blood brain barrier and are released into the blood during injury and in connection with many neurodegenerative brain diseases. However, the concentrations of many of these neural biomarkers in the blood can be so low that they are difficult to detect by conventional, analog immunoassay technologies. Furthermore, neurological pathophysiology is complex, and it has become clear that no single biomarker is sufficient to serve as comprehensive indicator of these processes. For this reason, the capability of Simoa to multiplex blood-based tests for multiple neural biomarkers into a single test has emerged as useful to facilitate biomarker profiling of neurological disorders. This capability has materially contributed to rapid research progress, notably in the Alzheimer’s disease landscape.

Our Spatial Biology platforms enable high-plex, single-cell protein analysis directly within intact brain tissue, making them highly relevant to neurology research and neurodegenerative disease markets. Neurological disorders such as Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, and amyotrophic lateral sclerosis ("ALS") are driven by complex cellular interactions—including neurons, glia, immune cells, and vascular components—that cannot be fully understood through bulk or dissociated assays. Our Spatial Biology technologies allow researchers to localize and quantify dozens of protein biomarkers simultaneously while preserving anatomical context, supporting the identification of disease-associated cell states, pathogenic microenvironments, and therapeutic targets. This capability is increasingly important as pharmaceutical and academic groups prioritize biomarker-driven drug development, patient stratification, and translational research in neurology, positioning spatial biology as a foundational tool in a large, growing, and underserved research and clinical development market.

Developments on the Alzheimer’s Disease Landscape

According to the Alzheimer’s Association, there are over 7 million individuals living with Alzheimer’s disease and other dementias in the United States, and that figure is expected to double by 2060. The FDA's approval of Leqembi and Kisunla as disease-modifying treatments for Alzheimer’s disease has underscored an urgent need for non-invasive, widely available blood tests to facilitate diagnosis in the early stages of the disease to identify patients for treatment when therapeutic intervention is most likely to provide clinical benefit. Established biomarker-based approaches to diagnostic workup for Alzheimer’s include positron emission tomography ("PET") imaging and CSF biomarkers for amyloid and phosphorylated tau, both of which are invasive, expensive, and may not be widely available. Recently two blood tests for assessing the risk of brain amyloid pathology associated with Alzheimer’s disease in individuals with early signs of cognitive impairment were cleared by the FDA. This is an important milestone demonstrating support by regulatory authorities for the use of high quality blood tests as part of Alzheimer’s diagnostic workflows. Assessing the effectiveness of an anti-amyloid Alzheimer’s therapy by testing for amyloid plaque reduction over the course of treatment with serial testing represents another potential opportunity for blood biomarker tests. The availability of a simple blood test for amyloid positivity has the potential to alleviate bottleneck and cost burdens and facilitate the accessibility of Alzheimer’s therapeutic intervention for patients. We believe our Simoa technology is well-suited to meet these critical needs.

Simoa Multi-Marker Algorithmic Test

Leveraging both the multiplexing and high sensitivity capability of Simoa, we have developed a multi-marker algorithmic test that combines five biomarkers (p-Tau 217, Aβ42, Aβ 40, NfL, and GFAP) and uses a proprietary algorithm for high accuracy plasma detection of amyloid pathology. Researchers have extensively studied these biomarkers to advance the understanding of how blood-based biomarkers reflect different aspects of Alzheimer’s pathology, to both further the basic knowledge of the disease pathophysiology, and to explore the potential of these biomarkers to predict disease state, severity, and progression. This work has resulted in a large body of published evidence that has advanced the understanding of the disease and facilitated drug development through the use of these biomarkers as exploratory indicators of drug target engagement. From a diagnostic test standpoint, a central concept has emerged: since these biomarkers reflect different aspects of Alzheimer’s pathology, combining their signals through logistic regression can enhance overall test accuracy. This information, together with clinical evaluations and cognitive testing, can help determine whether cognitive symptoms are the result of Alzheimer’s disease or another type of dementia.

We have partnered with the Alzheimer’s Drug Discovery Foundation to develop and clinically implement a multi-marker blood test to aid Alzheimer’s diagnosis and differential diagnosis of patients presenting with cognitive symptoms of uncertain origin. Validation data for the clinical performance of the test for amyloid detection was presented at the Clinical Trials on Alzheimer’s Disease annual meeting late 2024. The data across more than 1,000 patients showed that the test delivered best-in-class performance for amyloid detection accuracy as well as reduced uncertainty in borderline cases. We launched this multi-marker algorithmic test as an LDT in November 2024 under the brand name LucentAD Complete.

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Additionally, in November 2025 CMS approved a reimbursement rate of $897 for this test. A version of this multi-analyte algorithmic blood test received Breakthrough Device designation by the FDA, and we submitted a 510(k) premarket notification to the FDA earlier this year.

Other Neurological Conditions

Our ultra-sensitive Simoa technology has also been instrumental in advancing research into other neurological conditions, such as multiple sclerosis and traumatic brain injury ("TBI"). Evidence of the potential clinical utility of NfL as a biomarker in multiple sclerosis has progressed rapidly, and Simoa’s role in that progression has been foundational. In April 2022, the FDA granted our Simoa NfL serum test Breakthrough Device designation as a prognostic aid in assessing the risk of disease activity in patients diagnosed with relapsing-remitting multiple sclerosis ("RRMS"). The test has shown promise to be used in conjunction with clinical, imaging and laboratory findings as an aid in identifying RRMS patients who are at lower or higher risk for relapse within four years. We believe this prognostic information could be clinically useful in tailoring the therapeutic approach to more effectively treat the disease.

Current methods of TBI diagnosis involve CT scans that fail to diagnose approximately 90% of mild TBI. Simoa technology has demonstrated the sensitivity to identify relevant neurological biomarkers, such as NfL, tau, GFAP, and ubiquitin C-terminal hydrolase L1 ("UCH-L1"), to more adequately aid in diagnosis of TBIs and overall brain health. Researchers in neurology have used Simoa technology to study biomarkers in the blood of athletes after concussion in many high-impact sports. Simoa can measure critical neural biomarkers in blood that correlate to repeated head trauma from both concussions and subconcussive events with poor patient outcomes, including the potential development of Chronic Traumatic Encephalopathy, which currently can only be diagnosed after death via a brain autopsy.

Additional assays for blood-based biomarkers with potential utility in Alzheimer’s research and diagnostics have either been launched or are in development. These include brain-derived Tau, p-Tau 231, p-Tau 212, sTREM2, and PSD95.

Oncology and Immunology

Our Spatial Biology platforms are highly relevant to oncology research due to their ability to resolve the tumor microenvironment at single-cell resolution while preserving tissue architecture. Cancer progression, immune evasion, and therapeutic response are driven by spatially organized interactions among tumor cells, immune infiltrates, stromal cells, and vasculature—features that are not captured by bulk or non-spatial assays. Our technologies enable simultaneous measurement of dozens of protein biomarkers within intact tumor tissue, supporting biomarker discovery, mechanism-of-action studies, and identification of predictive and pharmacodynamic markers for immuno-oncology and targeted therapies. As oncology drug development increasingly relies on biomarker-guided patient selection and translational insights linking tissue biology to clinical outcomes, spatial biology has become a critical enabling technology, underpinning demand from pharmaceutical companies, translational research centers, and clinical research laboratories in one of the largest and fastest-growing life sciences markets.

Cancer immunotherapy is a promising new area that is significantly affecting cancer remission rates. One challenge of immunotherapy approaches is that the elicited immune responses are not always predictable and can vary from person to person and protocol to protocol. There exists a significant need to develop biomarker tools to monitor these drugs and their effects. Circulating protein biomarkers (serum and plasma) have the potential to be used in the field of health-oncology to stratify patients, predict response, predict recurrence, reveal mechanism of action and monitor for adverse effects. One technical challenge facing the health-oncology drug development process has been the availability of immunoassays with sufficient sensitivity to measure immunomodulatory biomarkers directly in serum and plasma. We have developed a number of tumor biomarker and immune modulation assays (cytokines and chemokines) that can be used to monitor tumor proliferation and host immune response. In particular key immune regulatory cells (T-regs, dendritic cells, macrophages) secrete very low amounts of the protein Interferon gamma (“IFN-gamma”) and these levels cannot be reliably measured in serum and plasma using conventional, immunoassay technology, however they can be tracked with our Simoa IFN-gamma assay. Additionally, we have developed an ultra-sensitive assay for ubiquitin C-terminal hydrolase L1 ("IL-6"), which is one of the cytokines commonly measured for monitoring cytokine release syndrome as an adverse effect in immunotherapies. Several studies have shown that our ultrasensitive assays can be valuable tools for monitoring health-oncology drugs and protocols.

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Inflammation

Inflammation underlies the response of the body to injury in a variety of diseases. Simoa assays can measure inflammatory and anti-inflammatory molecules in serum and plasma with unprecedented sensitivity. This has the potential to enable new discoveries into the role of inflammation in the biology of health and disease. Our Simoa technology measures low levels of inflammatory proteins, including cytokines and chemokines, that characterize a range of inflammatory diseases, including Crohn’s disease, asthma, rheumatoid arthritis, and neuro-inflammation. We believe the sensitivity of Simoa technology can provide a clearer picture of the underlying state of the immune response and disease progression.

Combining the ultra-sensitive capabilities of our Simoa technology with our Spatial Biology platform is highly relevant to inflammation research because inflammatory diseases are driven by localized, cell-to-cell signaling events that vary by tissue compartment and disease stage. Conditions such as autoimmune disorders, fibrosis, cardiovascular disease, and inflammatory bowel disease involve complex interactions among immune cells, parenchymal cells, and stromal elements that cannot be adequately characterized using bulk or non-spatial methods. Our Spatial technologies enable high-plex, single-cell protein analysis within intact tissue, allowing researchers to map inflammatory pathways, immune cell activation states, and spatial biomarkers associated with disease progression and therapeutic response.

Research and Development

We continue to seek to improve our technologies to enable more sensitive detection and measurement of biological molecules. This effort includes examining new assay formats to increase their performance. We intend to expand our assay menu to extend the scope of applications for our platforms to biomarkers of significant interest to the scientific community. Further, we are developing new instrumentation to update our current Simoa platforms, with a design that aims to ultimately have higher sensitivity and multiplexing. For example, in late 2025, we launched an early access program to our next generation instrument "Simoa ONE" to give key evaluators hands-on experience with the technology. We continue to gather feedback on this instrument to innovate its design and determine which features are most important.

Sales and Marketing

We distribute our instruments and consumables via direct field sales and support organizations located in North America and Europe and through a combination of our own sales force and third-party distributors in additional countries, including Australia, Brazil, China, Czech Republic, Cypress, India, Hong Kong, Israel, Japan, New Zealand, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, and UAE. In addition, we sell NfL antibodies and NfL ELISA kits produced by our Swedish subsidiary, UmanDiagnostics AB ("Uman"), directly and in conjunction with a distributor worldwide.

As of December 31, 2025, we had 151 employees in sales, sales support, and marketing, including technical field application scientists and field service personnel. This staff is primarily located in North America and Europe. We expect we will expand our sales, sales support, and marketing efforts in North America as it relates to the commercialization of our LucentAD Complete test. Additionally, we expect to continue to develop a comprehensive distribution and support network in China and other APAC region countries where significant new opportunities exist.

Manufacturing and Supply

We outsource the manufacturing of our Simoa bead-based instruments and Spatial Biology instruments to third-party manufacturers, and we manufacture our planar array instrument and all assay kits in our own facilities.

Instruments

Our HD-X instrument is supplied by STRATEC, based in Birkenfeld, Germany, and is manufactured and shipped from its Birkenfeld and Beringen, Switzerland facilities. Our SR-X instrument is supplied by Paramit, based in Morgan Hill, California, and is shipped to our global customers by Paramit. Our Spatial Biology instruments are manufactured by Columbia Tech, based in Westborough, Massachusetts. See the section titled "Key Agreements" for a description of our agreements with these manufacturers. Installation of, and training on, our instruments is provided by our employees where we conduct direct sales, and by distributors where sales are conducted through distributors.

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We believe this manufacturing strategy is efficient and conserves capital. However, in the event it becomes necessary to utilize a different contract manufacturer for the HD-X, SR-X, or Spatial Biology instruments, we could experience additional costs, delays and difficulties in doing so, and our business could be harmed.

Our SP-X instrument is manufactured, tested, shipped and supported by us from our Billerica, Massachusetts facility. All internal components are sourced domestically except one significant component that is sourced in Germany. These components are sourced from a limited number of suppliers, including certain single-source suppliers. Although we believe that alternatives would be available, it would take time to identify and validate replacement components, which could negatively affect our ability to supply SP-X instruments on a timely basis.

Consumables

We assemble our assay kits for our Simoa bead-based platforms and Spatial Biology platforms in our Billerica, Massachusetts facility. Our bead-based assays include all components required to run an enzyme-based immunoassay, such as beads, capture and detector reagents, enzyme reagents and enzyme substrate. Reagents for our assays are sourced from a limited number of suppliers, including certain single-source suppliers. Although we believe that alternatives would be available, it would take time to identify and validate replacement reagents for our assay kits, which could negatively affect our ability to supply assay kits on a timely basis.

Simoa disks for our bead-based platforms are supplied through a single source supplier pursuant to a long-term supply agreement with STRATEC Consumables GmbH, a subsidiary of STRATEC. We believe that this agreement provides for a sufficient notification period to allow for supply continuity and the identification and tech transfer to a new supplier in the event either party wishes to terminate the relationship. Our cuvettes for our bead-based platforms are single sourced through STRATEC, and the disposable tips used in our bead-based platforms are commercially available.

We assemble our 96-well sample plate kits for our planar array platform in our Billerica, Massachusetts facility. Reagents for our planar array assays include all components required to run an enzyme-based chemiluminescent immunoassay, such as capture antibody printed plates and detector reagents, enzyme reagents and enzyme substrate. These reagents are sourced from a limited number of suppliers, including certain single-source suppliers. Although we believe that alternatives would be available, it would take time to identify and validate replacement reagents for our assay kits, which could negatively affect our ability to supply assay kits on a timely basis. Because our planar array assays have a shelf life of 12 months, we believe we are able to mitigate this risk through inventory control.

NfL antibodies and NfL ELISA Kits

The storage of Uman’s proprietary NfL antibody producing hybridomas, as well as the cultivation and purification of the antibodies, is outsourced to a contract manufacturer, and bulk material of purified antibodies is delivered to Uman’s site in Umeå, Sweden. Functional testing and verification of concentration are performed at Uman before the material is approved for use in production activities. The antibodies currently have a shelf life of 18 months and can be aliquoted and sold as single reagents or used for the production of Uman’s NfL ELISA kits.

All components in Uman’s NfL ELISA kits are manufactured in-house at Uman from starting materials sourced from suppliers that have been evaluated and approved. Uman has entered into supply agreements with critical suppliers. The kit components include buffers (sample diluents and wash solutions), ELISA 96-well plates coated with a capture antibody, detector antibodies, streptavidine conjugates, substrates (TMB) and stop reagents. The final ELISA kit products are subject to quality control procedures, which include testing of human CSF or human serum quality control samples to assure a high batch consistency. After testing and batch record review, the material is released to market. The current shelf-life of the kits is 18 months (NfL ELISA (CSF)) or 13 months (NfL Serum ELISA).

Key Agreements

Development Agreement and Supply Agreement with STRATEC

In August 2011, as amended in November 2016 and July 2025, we entered into a Strategic Development Services and Equity Participation Agreement with STRATEC, pursuant to which STRATEC undertook the development of the Simoa HD instrument. In September 2011, as amended in October 2013, we also entered into a Supply and Manufacturing Agreement with STRATEC (the "STRATEC Supply Agreement"), pursuant to which STRATEC agreed to supply HD instruments to us, and we agreed to procure those instruments exclusively from STRATEC, subject to STRATEC’s ability

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to supply the instruments. We are responsible for obtaining any regulatory approval necessary to sell the instruments. The instrument price stipulated in the STRATEC Supply Agreement was established based on certain specified assumptions and is subject to certain adjustments.

The STRATEC Supply Agreement is terminable by either party on 12 months’ notice to the other party. The STRATEC Supply Agreement may also be terminated on the insolvency of a party or the uncured material breach of a party, or, by us, on a change of control of our company (subject to certain obligations to compensate STRATEC on such termination). On termination by us for STRATEC’s insolvency or uncured material breach or termination by STRATEC for convenience, we are granted a nonexclusive royalty free license of STRATEC intellectual property to manufacture the instruments.

Paramit Manufacturing Services Agreement

In November 2016, we entered into a Manufacturing Services Agreement (the "Paramit Agreement") with Paramit to produce and test our SR-X instrument on an as-ordered basis. We also engaged Paramit to supply spare parts for the SR-X instrument. Paramit has no obligation to maintain inventory in excess of any open purchase orders or materials in excess of the amount Paramit reasonably determines will be consumed within 90 days or within the lead time of manufacturing our instrument, whichever is greater. We have an obligation to purchase any material or instruments deemed in excess pursuant to the Paramit Agreement. The price is determined according to a mutually agreed-upon pricing formula. The parties agreed to review the pricing methodology yearly or upon a material change in cost.

The Paramit Agreement is terminable by either party for convenience with written notice to the other party given at least nine months prior to the end of the then-current annual term. The agreement may also be terminated by us with three months’ notice to Paramit upon the occurrence of (i) a failure of Paramit to obtain any necessary governmental licenses, registrations or approvals required to manufacture our instrument or (ii) an assignment by Paramit of its rights or obligations under the agreement without our consent. The Paramit Agreement is terminable by Paramit with 30 days’ notice to us in the event of a material breach after written notice and a 60-day opportunity to cure the breach.

Columbia Tech Manufacturing Agreement

In July 2019, Akoya entered into a Manufacturing Agreement ("the CT Agreement") with Columbia Tech to manufacture its Spatial Biology instruments on an as-ordered basis. We are responsible for obtaining any regulatory approval necessary to sell the instruments. The instrument price is established by Columbia Tech and is subject to certain adjustments.

The CT Agreement is terminable by either party for convenience upon 90 days' notice to the other party. The CT Agreement may also be terminated by either party with 30 days' notice of an uncured material breach, or by us if Columbia Tech fails to deliver ordered products within 45 days of the delivery date.

Intellectual Property

Our success depends in part on our ability to obtain and maintain intellectual property protection for our products and technology.

We rely primarily on a combination of patent, copyright, trademark, and trade secret laws, as well as contractual provisions with employees and third parties, to establish and protect our intellectual property rights. Our patent strategy is to pursue broad protection for key technologies, supplemented by additional patent filings covering conceptual methods, specific aspects of current and proposed products, and forward-looking applications and technological developments, and licensing of certain patent families from third parties. We also engage in strategic analysis of our owned and licensed patent assets and pursue additional patent claims from our existing portfolio that may provide us with market and other competitive advantages. We do not rely heavily on trade secret protection but do maintain a certain amount of in-house know-how that is not disclosed publicly.

We provide products to customers, commercial, and academic collaborators pursuant to agreements with non-disclosure terms and other conditions that impose restrictions on use and disclosure. We further make use of contractual obligations that require our employees, consultants, and contractors with access to our proprietary information to execute non-disclosure, non-competition and assignment of intellectual property agreements to preserve our intellectual property

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rights. We generally control access to our proprietary and confidential information through the use of internal and external controls that are subject to periodic review.

Our Simoa patent strategy protects but is not limited to: fundamental methods for detecting single molecules independent of the specific analyte to be detected, embodiments of the core technology directed to the detection of specific analytes, novel instrumentation, consumables, and manufacturing processes used in applying the invention to certain commercial products or future product opportunities and specific uses of the core technology (e.g., biomarkers and diagnostics).

Our Spatial Biology patent strategy protects but is not limited to: spatial / tissue multiplexing technologies and spatial / tissue signal amplification technologies for both protein and nucleic acids; selective labeling, RNA sequence identification and error correction visualizing tissues and compartments within cells, image, and signal processing technologies including spectral unmixing, dynamic optical correction, machine classifiers, multiple-image registration, systems and methods for whole-slide imaging, automated adjustment of imaging systems, extraction of pure spectra from sample images, focus determination in imaging systems as well as specific biomarkers or combinations thereof for use in discovery and diagnostics.

Our patent strategy is both offensive and defensive in nature, seeking to protect not only technology we currently practice but also alternative, related embodiments.

As of December 31, 2025, our active patent portfolio (owned or exclusively licensed) included approximately 154 issued patents worldwide with an additional 102 applications pending. Our owned or exclusively licensed patents and patent applications, if issued, are expected to expire between 2026 and 2043, in each case without taking into account any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees.

Our core Simoa technology, directed to general methods and devices for single molecule detection, originated at Tufts University ("Tufts"), in the laboratory of Professor David Walt, who is one of the founders of Quanterix. Professor Walt and his students pioneered the single molecule array technology, including technologies that enabled the detection of single enzyme labels in arrays of microwells, thereby facilitating ultra-sensitive detection. We have exclusively licensed from Tufts the relevant patent rights related to these technologies (see the section titled "Material Licenses").

Our core Spatial Biology labeling technology PhenoCycler (formerly CODEX) originated in the laboratory of Professor Garry P. Nolan at Stanford, who is a former member of Akoya's board of directors. Patent families covering this technology are exclusively licensed from Stanford University (see the section titled "Material Licenses").

Our key Spatial Biology imaging technology PhenoImager (formerly Phenoptics) originated at Cambridge Research and Instrumentation Inc, ("Cambridge Research"), a company that was later acquired by Caliper Life Sciences, Inc. ("Caliper Life Sciences"). Caliper Life Sciences was subsequently acquired by Perkin Elmer, Inc., subsequently known as Revvity ("PKI"). We purchased key patent assets covering this technology from PKI, Cambridge Research, and Caliper Life Sciences, and also licensed certain supplemental patents from PKI, Cambridge Research, and VisEn Medical Inc. ("VisEn Medical"). Some of the supplemental patents are exclusively licensed and others are non-exclusively licensed (see the section titled "Material Licenses").

In addition to our reliance on patent protection for our inventions, products and technologies, we also rely on trade secrets, know-how, confidentiality agreements, and continuing technological innovation to develop and maintain our competitive position. For example, some elements of our manufacturing processes, analytics techniques and processes, as well as computational-biological algorithms, and related processes and software, are based on unpatented trade secrets and know-how that are not publicly disclosed. Although we take steps to protect our proprietary information and trade secrets, including through contractual means with our employees, advisors and consultants, these agreements may be breached or may be unenforceable and we may not have adequate remedies. In addition, third parties may independently develop substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets or disclose our technology. As a result, we may not be able to meaningfully protect our intellectual property. For further discussion of the risks relating to our intellectual property, see the section titled "Risk Factors — Risks Related to our Intellectual Property."

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Material Licenses

Tufts University

In June 2007, as amended in April 2013, August 2017, and September 2020, we entered into a license agreement with Tufts, pursuant to which we obtained an exclusive, worldwide license to all patent rights to the Simoa bead-based technology owned by Tufts, as well as a non-exclusive license to related know-how. The rights licensed to us are for all fields of use and are sublicensable.

Under the terms of the agreement, as amended, we paid a one-time, non-refundable upfront fee and issued Tufts shares of our stock. We are required to pay Tufts low single-digit royalties on all net sales of products and services that use the licensed technology, as well as a portion of any sublicensing revenues. We are also obligated to pay annual maintenance fees, which are fully creditable against any royalty payments made by us, and a milestone payment upon any sublicense by us. We were also required to reimburse Tufts for all patent prosecution costs.

The term of the license agreement will continue on a country-by-country basis so long as there is a valid claim of a licensed patent in such country. Tufts may terminate the agreement or convert to a non-exclusive license in the event (1) we fail to pay any undisputed amount when required and fail to cure such non-payment within 60 days after receipt of notice from Tufts, (2) we are in breach of any material provision of the agreement and fail to remedy such breach within 60 days after receipt of notice from Tufts, (3) we do not demonstrate diligent efforts to develop a product incorporating the licensed technology, (4) we are found on five separate audits to have underpaid pursuant to the terms of the agreement, (5) we cease to carry on the business related to the licensed technology either directly or indirectly, or (6) we are adjudged insolvent, make an assignment for the benefit of creditors or have a petition in bankruptcy filed for or against us that is not removed within 60 days. We may terminate the agreement at any time upon at least 60 days’ written notice. Upon termination of the agreement, all rights revert to Tufts.

Stanford University

In November 2015, Akoya entered into an exclusive (equity) agreement with Stanford University ("Stanford"), pursuant to which Stanford granted Akoya an exclusive, sublicensable (subject to certain requirements), worldwide license under certain patent rights owned by Stanford relating to oligonucleotide-based biological sample labeling to make, use and sell products and services that are covered by such patent rights (the “Stanford Licensed Products”) in all fields of use. The patents are related to oligonucleotide-based labeling technology, and we refer to this technology as the CODEX 1 technology.

In November 2016, the agreement was amended to include an exclusive, sublicensable (subject to certain requirements), worldwide license granted to Akoya by Stanford under additional patent rights owned by Stanford relating to oligonucleotide-based biological sample labeling to make, use, and sell products and services that are covered by such patent rights, in all fields of use (such products and services are also included in the Stanford Licensed Products). We refer to the technology disclosed in the additional patents as the CODEX 2 technology. Akoya is obligated to use commercially reasonable efforts to develop, manufacture, sell and develop markets for Stanford Licensed Products, including with respect to accomplishing specific goals with specific deadlines set forth in the agreement.

Akoya made one-time upfront payments upon the execution of the agreement and amendments. We are required to pay Stanford annual license maintenance fees in the mid-five figures. We further agreed to make certain milestone payments based on specified patent issuance and sales milestone events. We are also obligated to pay Stanford a low single-digit percentage royalty on net sales of Stanford Licensed Products and a portion of any of its sublicensing income.

Subject to Stanford’s approval, we control the prosecution and maintenance of the licensed patents and, if we develop Stanford Licensed Products, we have the first right to institute a suit, or defend any declaratory judgment action, related to third-party infringement of the licensed patents.

The agreement will continue until the expiration, revocation, invalidation or abandonment of the last patent or patent application that is licensed to us, unless terminated earlier in accordance with its terms. The last licensed patent is set to expire in 2036. We may terminate the agreement at any time by providing advance written notice of at least 30 days. Stanford may terminate the agreement if we violate or fail to perform any material terms thereof or for our failure to achieve certain milestones or use commercially reasonable efforts to develop and commercialize the Stanford Licensed Products and fail to cure such violation or failure within 30 days of written notice from Stanford.

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PKI/Revvity, Cambridge Research, and VisEn Medical

In September 2018, in connection with the acquisition of the Quantitative Pathology Solutions ("QPS") technology from PKI, Akoya entered into a license and royalty agreement with PKI, Cambridge Research, and VisEn Medical, (collectively, the "Licensor"), pursuant to which the Licensor granted Akoya an exclusive, nontransferable, sublicensable (subject to certain conditions), worldwide license within certain fields of use under certain patent rights and know-how owned by the Licensor to make, use, and sell products within such fields of use, as well as a similar, non-exclusive license under certain other patent rights. The licensed patents relate to methods and systems for analyzing biological samples, and in particular, slide-mounted tissue samples.

We are obligated to pay the Licensor royalties ranging from low to mid single-digit percentages on net sales of products covered by either license on a decreasing schedule that ends upon the expiration of the last valid claim of the licensed patents, at which point the agreement shall terminate and our rights and licenses thereunder shall survive on a fully-paid up, royalty-free basis. The last licensed patent is set to expire in 2036. Neither we nor the Licensor has the right to terminate the agreement prior to such expiration.

The Licensor has the first right to control the prosecution, maintenance and defense of the licensed patents. We have the first right to enforce any exclusively licensed patent with respect to third-party infringement occurring solely within its licensed field of use, and Licensor has the first right to enforce the license patents with respect to any other third-party infringement. If any exclusively licensed patent is believed to be infringed by the development, manufacture, use, offer for sale, sale or importation of a product by the third-party solely inside field of use worldwide, the Licensor has the first right to institute, prosecute and control any action or proceeding with respect to such infringement of such patent.

University of Washington

In June 2018, Akoya entered into an exclusive patent license agreement with the University of Washington (the "University"), pursuant to which the University granted Akoya an exclusive, sublicensable (subject to certain conditions), worldwide license in certain fields of use under certain patent rights owned by the University relating to technology for molecular profiling of cells and tissue specimens, to make, use and sell products that are covered by such patent rights, or the Washington Licensed Products. The licensed patents are related to the detection of biomolecules, particularly proteins and nucleic acids, in biological samples.

We are obligated to pay the University a low single-digit percentage running royalty on net sales of Washington Licensed Products, subject to certain minimum annual royalty payments and potential reductions based on a royalty-stacking allowance for certain third -party rights that are required to be obtained to make, use, sell or import Washington Licensed Products. We are also obligated to make cumulative one-time payments to the University upon the achievement of certain commercial milestones, as well as sharing a portion of any of its non-royalty sublicensing income.

We are obligated to use commercially reasonable efforts to commercialize the inventions covered by the licensed patent rights and to make and sell Washington Licensed Products as soon as practicable and maximize sales thereof, including with respect to accomplishing specific goals with specific deadlines set forth in the agreement.

The University must conduct the prosecution of the licensed patents per our instructions and at our expense, subject to certain exceptions. We have the first right to defend and enforce the licensed patents at its expense.

The agreement will expire when all licensed patent rights have terminated, unless terminated earlier in accordance with the terms thereof. The last licensed patent is set to expire in 2032. We may terminate the agreement at any time by providing advance written notice of at least 60 days. The University may terminate the agreement if we violate or fail to perform any material term thereof and fail to cure such violation or failure within 60 days of written notice from the University. In addition, the University may terminate the exclusive license agreement upon 10 days’ prior written notice upon certain insolvency-related events involving us or should we challenge the validity of the licensed patents.

Competition

We compete with both established and development-stage life science companies that design, manufacture, and market instruments for proteomics discovery and clinical research applications. Companies such as Bio-Techne, MesoScale Discovery, SEER, Bio-Rad Laboratories, Alamar, Spear Bio, and others, have products for protein measurements in biofluids that compete in certain segments of the market in which we sell our products. In the spatial biology market, there

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are companies, both established and early-stage, that have indicated that they are designing, manufacturing, and marketing products for, among other things, tissue analysis, single-cell analysis and spatial analysis. These companies include 10x Genomics, Vizgen, Bio-Techne, Bruker, Miltenyi Biotec, and Standard BioTools, each of which has products that compete to varying degrees with some but not all of our product solutions, as well as a number of other emerging and established companies.

Our Accelerator Laboratory competes with other research laboratories such as LabCorp, Covance, Q2 Solutions, Rules Based Medicine, Monogram Biosciences, Frontage, Thermo Fisher Scientific, and others, some of which are customers of ours. In addition, as we or our partners expand the applications for our products to include diagnostics, we expect to compete with companies such as Roche, Fujirebio, Danaher, and C2N Diagnostics. Furthermore, our technology and products are showing promise for non-invasive early disease detection, and in the future, we could experience competition from companies that develop and market imaging and other molecular detection technologies.

Many of the companies with which we compete or will compete have substantially greater resources than we have. However, we believe we are differentiated from our competitors for several reasons, including our position as a leader in a large and growing market, proprietary technologies, rigorous product development processes, scalable infrastructure, and positive customer experience. We believe our customers view our products and company favorably because of these differentiators.

The life science instrumentation and lab services industries in which we operate are highly competitive and expected to grow more competitive with the increasing knowledge gained from ongoing research and development. we believe the principal competitive factors for us include:

•sensitivity;

•cost of instruments and consumables;

•reputation among customers and key opinion leaders;

•innovation in product offerings;

•accuracy and reproducibility of results; and

•customer support infrastructure.

We believe that we are well positioned with respect to these competitive factors and expect to enhance our position through ongoing global expansion, innovative new product introductions and ongoing collaborations, and partnerships with key opinion leaders.

For further discussion of the risks we face relating to competition, see the section titled “Risk Factors — Risks Related to our Business and Industry — Our market is highly competitive, and if we cannot compete successfully with our competitors, we may be unable to increase or sustain our revenue, or achieve and sustain profitability.”

Government Regulation

The majority of our products are currently intended for research use only ("RUO") applications, although our customers may use our products to develop their own products that are subject to regulation by the FDA or CMS. Although in vitro diagnostic products intended for RUO are not currently required to obtain premarket clearance or approval by the FDA, products labeled as RUO are subject to the FDA’s premarket review requirements if they are determined to be intended for use for clinical rather than non-clinical research purposes. Consequently, other than our four LDTs intended for clinical testing, our products are labeled and intended “For Research Use Only. Not for Diagnostic Procedures.”

The FDA has issued Final Guidance for Industry and Food and Drug Administration Staff on "Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only" (the "RUO/IUO Guidance"). The purpose of this FDA guidance document is to provide the FDA’s current thinking on when IVD products are properly labeled for RUO or for investigational use only ("IUO") and when products labeled RUO or IUO will be viewed by the FDA as intended for clinical use. The RUO/IUO Guidance explains that the FDA will review the totality of the circumstances when evaluating whether equipment and testing components are properly labeled as RUO. Merely including

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a labeling statement that a product is intended for research use only will not necessarily exempt the device from the FDA’s premarket notification and clearance process (510(k)), premarket approval, or other requirements, if the circumstances surrounding the distribution of the product indicate that the manufacturer intends its product to be used for clinical diagnostic use. These circumstances may include written or verbal marketing claims or links to articles regarding a product’s performance in clinical applications, a manufacturer’s provision of technical support for clinical validation or clinical applications, or solicitation of business from clinical laboratories, all of which could be considered evidence of intended uses that conflict with RUO labeling. We believe that our labeling and promotion of our products, including the custom assay RUO products developed by the Accelerator Laboratory, is consistent with the RUO/IUO Guidance because we have not promoted our products for clinical use in humans.

In vitro diagnostics ("IVD") tests that are commercially distributed and intended for clinical diagnostic use are regulated by the FDA as medical devices, however, the FDA has historically not regulated most laboratory tests referred to as LDTs (as discussed further below). We currently offer four LDTs through our CLIA-certified laboratory: (1) an LDT to quantitatively measure p-Tau 181 in plasma as an aid in diagnostic evaluation of Alzheimer’s disease; (2) an LDT to quantitatively measure NfL in serum as an aid in the evaluation of individuals for possible neurodegenerative conditions or other causes of neuronal or central nervous system damage; (3) an LDT to quantitatively measure p-Tau 217 in plasma to aid in the diagnosis of Alzheimer’s disease; and (4) a multi-marker (p-Tau 217, Aβ42, Aβ40, NfL, and GFAP) algorithmic LDT, under the brand name LucentAD Complete, for high accuracy plasma detection of amyloid pathology to aid in diagnostic evaluation of patients with cognitive issues who may have Alzheimer’s disease.

Clinical Laboratory Improvement Amendments of 1988, Regulation of LDTs and State Regulation

We own and operate a CLIA-certified laboratory. CLIA, along with federal regulations promulgated under CLIA, apply to all clinical laboratory testing performed on humans in the United States (with the exception of research testing that does not report patient specific results). A clinical laboratory is defined by CLIA as any facility that performs examinations of specimens obtained from humans for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of health of, human beings. CLIA requires such laboratories to be certified by the federal government (or a CMS-approved accreditation organization) and mandates compliance with various operational, personnel, facilities administration, quality and proficiency testing requirements intended to ensure that testing services are accurate, reliable and timely. CLIA certification also is a prerequisite to be eligible to bill state and federal health care programs, as well as many private insurers, for laboratory testing services.

In addition, CLIA requires certified laboratories to enroll in an approved proficiency testing program for each of the specialties and subspecialties for which it is certified. If a laboratory fails to achieve a passing score on a proficiency test, then its CLIA certificate may be suspended, limited or revoked, or other sanctions may be imposed.

As a condition of CLIA certification, laboratories are subject to survey and inspection every other year (except laboratories with only a certificate of waiver or certificate of provider-performed microscopy procedures are not subject to biennial inspections), in addition to being subject to additional random inspections. The biennial survey is conducted by CMS, a CMS agent (typically a state agency), or a CMS-approved accreditation organization.

High complexity, CLIA-certified laboratories, such as ours, frequently develop testing procedures to provide diagnostic results to customers. These tests have been offered by high-complexity laboratories for the last few decades as LDTs, the validation and performance of which are subject to CMS oversight through its enforcement of CLIA. The FDA also has claimed that it has regulatory authority over LDTs under the agency’s medical device authorities, but historically did not enforce those requirements with respect to most LDTs. However, in April 2024, the FDA ended its policy of enforcement discretion for LDTs and finalized a rule that would subject nearly all LDTs—including the LDTs that we offer—to regulation as devices under the Federal Food, Drug, and Cosmetic Act ("FDCA"). In response to FDA's final rule, several organizations filed legal challenges, asserting that the FDA rule violated the Administrative Procedure Act because LDTs do not qualify as “devices” under the FDCA. On March 31, 2025, a federal district court agreed with the challengers, holding that LDTs are laboratory services and do not meet the definition of a “device” in the FDCA. Therefore, the district court held that FDA’s rule was invalid and FDA could not regulate LDTs as devices. See ACLA v. FDA, No. 4:24-cv-00479-SDJ (E.D. Tex. Mar. 31, 2025). The FDA did not appeal that district court decision and subsequently withdrew the LDT rule.

Notwithstanding this district court decision, and FDA’s decision to not appeal, it is possible that in the future the FDA could again attempt to assert that LDTs are medical devices and must comply with the requirements of the FDCA. It is also possible that the FDA could attempt to assert that some LDTs do qualify as an “LDT.” Historically, FDA defined an

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LDT as a test that is intended for clinical use and is designed, manufactured, and used within a single high-complexity, CLIA-certified laboratory. If a diagnostic test commercialized by a clinical laboratory does not meet all elements of this definition, it is possible that the FDA could assert that the test is not an LDT and is subject to its jurisdiction as a medical device.

If a laboratory is out of compliance with state laws or regulations governing licensed laboratories or with CLIA, it may be subject to enforcement actions that may include suspension, limitation, or revocation of the license or CLIA certificate, assessment of financial penalties or fines, or imprisonment. Loss of a laboratory’s CLIA certificate or state license may also result in the inability to receive payments from state and federal health care programs as well as private third-party payors.

When we perform clinical diagnostic testing, we may be subject to HIPAA, depending on the types of transactions we engage in, as well as additional federal and state laws that impose a variety of fraud and abuse prohibitions on healthcare providers, including clinical laboratories.

Europe/Rest of World Government Regulation

We must obtain the requisite approvals from regulatory authorities in non-U.S. countries prior to the commencement of clinical trials or marketing of our product for clinical diagnostic use in those countries. The regulations in other jurisdictions vary from those in the U.S. and may be easier or more difficult to satisfy and are subject to change. For example, in the European Union ("E.U.") new regulations recently entered into force that introduce greater regulation of medical devices and IVDs. The IVD regulation is significantly different from the IVD Directive that it replaces in that it ensures that the new requirements apply uniformly and on the same schedule across the member states, includes a risk-based classification system and increases the requirements for conformity assessment.

The CE registration for the NfL ELISA assay kit of our subsidiary Uman was approved in March 2014 under the IVD Directive. Under the IVD Directive, the assay is classified as a general IVD product and required self-certification with no involvement of a notified body/authority. The IVD Regulation introduces a new classification system for IVDs and assessment by a notified body is required for class B, C, and D products. Uman’s NfL ELISA assay kit is classified as a class B product and must fully comply with (and have a CE mark issued under) the IVD Regulation by May 2027 (subject to extension of the transitional periods in the IVD Regulation). The new requirements include an ISO 13485 certification of the quality system (which Uman received in July 2018) and increased technical evidence and follow-up of performance of the specific product (e.g., clinical evidence and post-market activities). The work to evaluate and to meet the new technical requirements is on-going. When all requirements are met, a notified body will be contacted, and the certification initiated.

The NF-light Serum ELISA is currently sold only as a RUO product (not intended for diagnostic use). Work is on-going to prepare a technical file compliant with the IVD Regulation for this product as well.

Other Governmental Regulation

Privacy and Data Security Laws and Regulations

As a business with a global footprint, compliance with evolving regulations and standards in privacy and data security has resulted, and may continue to result, in increased costs, new compliance challenges, and the threat of increased regulatory enforcement activity. Our business relies on various safeguards to secure electronic transmission, storage and hosting of sensitive information, including personal information, protected health information, financial information, intellectual property, and other sensitive information related to our customers and workforce.

For example, in the U.S., the collection, maintenance, protection, use, transmission, disclosure, and disposal of certain personal information and the security of medical devices are regulated at the U.S. federal and state, international, and industry levels. U.S. federal and state laws protect the confidentiality of certain patient health information, including patient medical records, and restrict the use and disclosure of patient health information by health care providers. Privacy and Security Rules under HIPAA, as amended by HITECH, govern the use, disclosure, and security of protected health information by “Covered Entities,” (which include health care providers that submit electronic claims, health plans, and health care clearinghouses) and by their “Business Associates” (which is anyone that performs a service on behalf of a Covered Entity involving the use or disclosure of protected health information and is not a member of the Covered Entity’s workforce). Rules under HIPAA and HITECH include specific security standards and breach notification requirements. The U.S. Department of Health and Human Services (through the Office for Civil Rights) has direct civil enforcement

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authority against Covered Entities and Business Associates with regard to both the Security and Privacy Rules. The U.S. Department of Justice has criminal enforcement authority against Covered Entities, Business Associates, and certain other entities and individuals. In addition, State Attorneys General may bring enforcement actions under HIPAA. Generally we are not a Covered Entity, however, we may operate as a Business Associate to Covered Entities under certain circumstances.

In addition, a number of states have also adopted laws and regulations that may affect our privacy and data security practices for personal information, such as comprehensive state privacy laws that govern the use, disclosure and protection of personal information, such as certain health information, Social Security numbers, and credit card account data. State consumer protection laws and consumer health privacy laws also establish privacy and security standards for use and management of personal information or consumer health data, including information related to consumers and care providers.

Outside the U.S., we are impacted by the privacy and data security requirements at the international, national, and regional level, and on an industry specific basis. Legal requirements in foreign countries relating to the collection, storage, handling and transfer of personal data and potentially intellectual property continue to evolve with increasingly strict enforcement regimes. More privacy and security laws and regulations are being adopted, and more are being enforced, with potential for significant financial penalties. In the E.U., stringent data protection and privacy rules which substantially impact the use of patient data across the healthcare industry became effective in May 2018. The General Data Protection Regulation ("GDPR") applies uniformly across the E.U. and includes, among other things, a requirement for prompt notice of data breaches to data subjects and supervisory authorities in certain circumstances and significant fines for non-compliance. The GDPR also requires companies processing personal data of individuals residing in the E.U. to comply with E.U. privacy and data protection rules. In the area of health data, the GDPR is supplemented by national laws and regulations that are less harmonized.

Because data privacy laws and regulations continue to expand, differ from jurisdiction to jurisdiction, and are subject to evolving (and at times inconsistent) governmental interpretation, compliance with these laws and regulations may require significant additional expenditures or changes in products or business that increase competition or reduce revenue. Noncompliance could result in the imposition of fines, penalties, or orders to stop noncompliant activities.

Environmental Health and Safety Laws

We are subject to federal, state, and local laws and regulations related to the protection of the environment, the health and safety of employees and the handling, transportation, storage and disposal of medical specimens, infectious and hazardous waste and radioactive materials. For example, the U.S. Occupational Safety and Health Administration (“OSHA”), has established extensive requirements relating specifically to workplace safety for healthcare employers in the U.S. This includes requirements to develop and implement multi-faceted programs to protect workers from exposure to blood-borne pathogens, including preventing or minimizing any exposure through needle stick injuries. OSHA also regulates the use of hazardous chemicals in the workplace. Likewise, we are subject to the U.S. Environmental Protection Agency and state requirements relating to the management and disposal of hazardous waste, and state requirements relating to the disposal of regulated medical waste. For purposes of transportation, some biological materials and laboratory supplies are classified as hazardous materials and are subject to regulation by one or more of the following agencies: the U.S. Department of Transportation, the U.S. Public Health Service, the U.S. Postal Service, and the International Air Transport Association. We generally use third-party vendors to dispose of regulated medical waste, hazardous waste, and radioactive materials that we may use during our research and services.

Employees and Human Capital

As of December 31, 2025, we had 450 full-time employees, of which 151 worked in sales, sales support, field service, and marketing, 24 worked in engineering and research and development, 198 worked in manufacturing and operations and 77 worked in general and administration. Of our 450 full-time employees, 382 were located in the United States and 68 were located in 14 foreign countries. None of our employees are represented by a labor union or subject to a collective bargaining agreement. Our culture emphasizes the impact our work has on the detection of neurological and other critical disorders.

Our success depends upon our ability to attract and retain highly qualified employees. Talent management is critical to our ability to execute our long-term growth strategy, and we seek to cultivate a high performing pool of talent by providing career growth, on-the-job learning opportunities and competitive total rewards.

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Workforce Compensation and Pay Equity

We provide competitive compensation and benefits programs to help recruit and retain our high performing employees. We utilize third party benchmark compensation data to assist in the evaluation of market wages. Our compensation is designed to attract, retain, and motivate employees to achieve results while balancing short- and long-term company performance. All our employees are eligible for an annual bonus and/or commission plan, a matching 401(k) Plan (in the case of U.S. employees), healthcare and insurance benefits, paid time off, family leave, employee assistance programs, and behavioral health services. Additionally, some of our employees are eligible for annual equity-based grants with vesting conditions designed to award our employees’ performance and encourage retention.

Company Culture

We are committed to an inclusive culture which is grounded on our values of integrity, respect, and equality. In support of our inclusive culture, we sponsor an internal group of culture champions comprised of employees and executives whose mission is to provide respectful workplace training and awareness to strengthen employee understanding and knowledge of these values. As of December 31, 2025, approximately 45% of our employees were women and approximately 33% of our employees were people of color.

We expect all personnel working at Quanterix, employees, interns, and contractors, to observe the highest levels of business ethics, integrity, and mutual respect. Our employee handbook and Corporate Code of Conduct and Ethics set forth policies that reflect our values and provide guidance for registering complaints in the event of any violation of our policies. An “open door” policy is maintained at all levels of the organization, and any form of retaliation against an employee for making a good faith complaint is strictly prohibited.

Employee Engagement and Wellness

The success of our business is dependent on the physical and mental well-being of our employees. Accordingly, we are committed to creating a safe and healthy workplace for all personnel. We provide our employees with a wide range of policies and practices to ensure an environment of physical and psychological safety and well-being.

Corporate Information

We were incorporated under the laws of the State of Delaware in April 2007 under the name "Digital Genomics, Inc.". In August 2007, we changed our name to "Quanterix Corporation". Our principal executive offices are located at 900 Middlesex Turnpike, Billerica, Massachusetts 01821, and our telephone number is (617) 301-9400.

Information Available on the Internet

Our Internet website address is www.quanterix.com. The information contained on, or that can be accessed through, our website is not a part of or incorporated by reference in this Annual Report on Form 10-K. We have included our website address in this Annual Report on Form 10-K solely as an inactive textual reference. We make available free of charge through our website our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Sections 13(a) and 15(d) of the Securities Exchange Act of 1934, as amended ("Exchange Act"). We make these reports available through the "Investors—Financial Information—SEC Filings" section of our website as soon as reasonably practicable after we electronically file such reports with, or furnish such reports to, the SEC. We also make available, free of charge on our website, the reports filed with the SEC by our executive officers, directors and 10% stockholders pursuant to Section 16 under the Exchange Act as soon as reasonably practicable after copies of those filings are provided to us by those persons. Our electronically filed reports and other information that we file with the SEC can be viewed on the SEC’s website at www.sec.gov.

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