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

Key Terms

510(k) regulatory

A 510(k) is a U.S. regulatory submission that a medical device maker uses to show a new device is as safe and effective as an already-approved device, allowing the regulator to clear it for sale rather than requiring the longer, more stringent approval process. For investors, a cleared 510(k) usually means lower regulatory risk and a faster path to market, which can speed revenue generation and reduce uncertainty—similar to proving a new appliance works like a trusted existing model.

breakthrough device designation regulatory

A breakthrough device designation is a regulatory program that gives promising medical devices for serious or life‑threatening conditions priority support and faster review from a health authority (e.g., the U.S. FDA). Think of it as a “fast lane” or VIP pass through development and review: it can shorten time to market, lower regulatory uncertainty, and boost a company’s commercial prospects — but it is not an approval by itself.

amyloid brain plaques medical

Clumps of a protein that build up between nerve cells in the brain, similar to sticky residue that clogs a pipe or lint that gathers on a sweater. They matter to investors because these plaques are a key target for drugs, tests and treatments; evidence that a therapy reduces or clears plaques can drive regulatory approvals, change projected healthcare costs and dramatically affect the market value of companies developing diagnostics or medicines.

p-Tau 217 medical

p-tau 217 is a form of the tau protein that carries a specific chemical tag at one spot (site 217) and can be measured in blood or spinal fluid as an early signal of Alzheimer’s-type brain damage. Like a smoke alarm sensing early signs of a fire, rising p-tau 217 levels help doctors and researchers spot disease earlier, guide who qualifies for trials, and influence the demand for diagnostics and therapies—factors that affect healthcare spending and investment opportunities.

Aβ42 medical

aβ42 is a specific form of a small protein fragment made of 42 building blocks that can clump together in the brain; those clumps are a hallmark of Alzheimer’s disease. Investors watch aβ42 levels because tests, drugs or trial results that change its amount or distribution act like key evidence about whether a treatment or diagnostic is working—similar to seeing whether a stain-removal product actually removes stubborn, sticky crumbs.

Aβ40 medical

Aβ40 is a small protein fragment produced when a larger brain protein is sliced into pieces; one of these pieces is 40 amino acids long. It is measured as a biomarker because abnormal levels or balances of Aβ40 versus other amyloid fragments can signal processes linked to neurodegenerative diseases, so changes in Aβ40 in trials or diagnostic tests can materially affect the perceived success of therapies and thus investor valuations in neuroscience-related companies.

Submission utilizes the comprehensive five-analyte panel and algorithm that formed the basis for Quanterix’s LucentAD® Complete LDT

BILLERICA, Mass.--(BUSINESS WIRE)-- Quanterix Corporation (Nasdaq: QTRX), a company transforming healthcare by accelerating biomarker breakthroughs from discovery to diagnostics, today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for a 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 AD. The 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. The test 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.

The multi-analyte algorithmic blood test utilizes Quanterix’s proprietary Simoa® technology to measure a panel of five key analytes: p-Tau 217, Aβ42, Aβ40, GFAP, and NfL. By integrating these AD-relevant biomarkers of amyloid pathology, tau pathology, neuroinflammation, and axonal damage into a single algorithmic result, the test provides a more comprehensive assessment of the biological drivers of Alzheimer’s disease than single-analyte assays. This multi-analyte approach is designed to improve diagnostic clarity, particularly in the early stages of disease progression where single-analyte levels can often fall into an "intermediate" or inconclusive range.

The submission is supported by extensive clinical evidence recently published in Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring spanning three independent cohorts and over 1,800 symptomatic patients. Simoa digital sensitivity enables a quantitative test result for every patient, overcoming the sensitivity limitations often found in conventional analog immunoassay methods and mass spectrometry. Furthermore, the unique inclusion of multiplexed GFAP and NfL can enable potential differential and prognostic insights, extending patient risk evaluations beyond a static amyloid status readout as provided by p-Tau 217 and ratio tests.

“The strong execution of the Quanterix team has resulted in this submission, a watershed moment for Quanterix and millions of families seeking clearer answers in the fight against Alzheimer’s disease,” said Mike Miller, Chief Operating Officer of Quanterix. “Both research and extensive clinical validation evidence confirm that a comprehensive, multi-analyte panel is essential for capturing the complexity and trajectory of this disease. This filing is the next step in our strategy to establish our technology as a gold standard in clinical diagnostics, offering a scalable solution that bridges the gap between early detection and the emerging class of disease-modifying therapies.”

About Quanterix

Quanterix is a global leader in ultra-sensitive biomarker detection, enabling breakthroughs in disease research, diagnostics, and drug development. Its proprietary Simoa® technology delivers industry-leading sensitivity, allowing researchers to detect and quantify biomarkers in blood and other fluids at concentrations far below traditional limits. With approximately 6,000 peer-reviewed publications, Quanterix has been a trusted partner to the scientific community for nearly two decades. In 2025, Quanterix acquired Akoya Biosciences, The Spatial Biology Company®, adding multiplexed tissue imaging with single-cell resolution to its portfolio and 1,396 installed instruments. Together, the combined company offers a uniquely integrated platform that connects biology across blood and tissue—advancing precision medicine from discovery to diagnostics. Learn more at www.quanterix.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release are based on Quanterix’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause Quanterix’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Quanterix’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein. Except as required by law, Quanterix assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

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Source: Quanterix Corporation