Quanterix Submits FDA 510(k) for Multi-Analyte Alzheimer's Blood Test

Quanterix QTRX recently announced the submission of a 510(k) premarket notification to the FDA for its multi-analyte algorithmic blood test designed to aid in the evaluation of patients with cognitive symptoms for possible Alzheimer’s disease. The submission underscores progress in the company’s effort to deliver non-invasive, high-performance diagnostic solutions for the clinical assessment of patients with Alzheimer’s disease.

Per management, the 510(k) submission reflects strong operational execution and represents a pivotal step for Quanterix in addressing the diagnostic needs associated with Alzheimer’s disease. Research and extensive clinical validation support the use of a comprehensive, multi-analyte approach to better characterize disease complexity and progression. The filing advances Quanterix’s strategy to position its technology as a clinical diagnostic standard, providing a scalable solution that supports earlier identification and aligns with the growing availability of disease-modifying therapies.

Likely Trend of QTRX Stock Following the News

Following the announcement, shares of QTRX lost 0.8% at yesterday’s closing. Over the past six months, shares of the company have climbed 8.2% against the industry’s 9.4% decline. However, the S&P 500 has risen 13.7% during the same time frame.

In the long run, the 510(k) submission represents a value-creating catalyst for QTRX’s multi-analyte, algorithmic blood test for Alzheimer’s disease, reinforcing its transition from a research-focused platform provider toward regulated clinical diagnostics. Extensive clinical validation across large patient cohorts and FDA Breakthrough Device Designation enhance the credibility and regulatory visibility of the company’s Simoa technology. Pending FDA clearance would expand Quanterix’s addressable market by enabling broader adoption of non-invasive Alzheimer’s diagnostics, particularly in earlier disease stages where clinical need is high. The integrated multi-biomarker approach also differentiates the company from single-analyte competitors, supporting potential pricing power and long-term clinical relevance in Alzheimer’s diagnosis and treatment decisions.

QTRX currently has a market capitalization of $303.62 million.

More on the FDA Submission

The multi-analyte test had earlier received FDA Breakthrough Device Designation, reflecting its potential to improve the diagnosis of serious and irreversibly debilitating conditions. The test is designed to assess whether patients with cognitive symptoms are likely to have amyloid plaque pathology in the brain — a defining feature of Alzheimer’s disease — by providing diagnostic insight through a non-invasive blood test.

The multi-analyte, algorithm-based blood test is built on Quanterix’s Simoa technology and measures five Alzheimer’s disease-related biomarkers — p-Tau 217, Aβ42, Aβ40, GFAP and NfL. By combining markers of amyloid pathology, tau pathology, neuroinflammation and axonal injury into a single algorithmic readout, the test delivers a more holistic view of underlying disease biology compared with single-biomarker tests. This approach is expected to enhance diagnostic interpretability in earlier disease stages where individual biomarker readings may fall into intermediate or inconclusive ranges.

The 510(k) submission is supported by clinical data published in Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring, encompassing three independent cohorts and more than 1,800 symptomatic patients. The sensitivity of Simoa technology enables quantitative results across the full patient population, addressing limitations associated with traditional immunoassays and mass spectrometry. In addition, the inclusion of multiplexed GFAP and NfL is intended to provide potential differential and prognostic insights, expanding assessment beyond amyloid status alone.

Industry Prospects Favoring the Market

Going by the data provided by Precedence Research, the Alzheimer’s disease diagnostics and treatment market was valued at $7.72 billion in 2025 and is expected to witness a CAGR of 9% through 2032. Factors like increasing use of neuroimaging technologies such as PET scans for early and accurate diagnosis, the development of monoclonal antibodies targeting amyloid and tau proteins, and the integration of AI in diagnostics and drug discovery are driving the market’s growth.

Other News

Quanterix announced the publication of a study in JAMA Network Open evaluating the prognostic value of a multi-biomarker approach in Alzheimer’s disease. Conducted by researchers at Amsterdam UMC, the study found that combining multiple biomarkers at baseline, together with their longitudinal trends, provided a more robust assessment of clinical risk than individual markers alone. Using the company’s Simoa ultra-sensitive platform, investigators measured biomarkers across four key disease pathways — amyloid, tau, neuroinflammation and neurodegeneration. Results showed that a multi-analyte model delivered the highest predictive accuracy, achieving a C-index of 0.90 for identifying individuals with Subjective Cognitive Decline.

Quanterix Corporation Price

Quanterix Corporation price | Quanterix Corporation Quote

QTRX’s Zacks Rank & Other Stocks to Consider

Currently, QTRX carries a Zacks Rank #2 (Buy).

Some other top-ranked stocks from the broader medical space are Veracyte VCYT, AtriCure ATRC and Boston Scientific BSX.

Veracyte, sporting a Zacks Rank #1 (Strong Buy) at present, reported third-quarter 2025 adjusted earnings per share (EPS) of 51 cents, which surpassed the Zacks Consensus Estimate by 59.4%. Revenues of $131.8 million beat the Zacks Consensus Estimate by 5.5%. You can see the complete list of today’s Zacks #1 Rank stocks here.

VCYT has an estimated earnings recession rate of 3% for 2026 compared with the industry’s 17.6% rise. The company beat earnings estimates in the trailing four quarters, the average surprise being 45.1%.

AtriCure, currently carrying a Zacks Rank #2, reported a third-quarter 2025 adjusted loss of 1 cent per share, surpassing the Zacks Consensus Estimate by 90.9%. Revenues of $134.3 million beat the Zacks Consensus Estimate by 2.1%.

ATRC has an estimated earnings growth rate of 91.7% for 2026 compared with the industry’s 17.5% rise. The company beat earnings estimates in the trailing four quarters, the average surprise being 67.1%.

Boston Scientific, currently carrying a Zacks Rank #2, reported a third-quarter 2025 adjusted EPS of 75 cents, which surpassed the Zacks Consensus Estimate by 5.6%. Revenues of $5.07 billion beat the Zacks Consensus Estimate by 1.9%.

BSX has an estimated long-term earnings growth rate of 16.4% compared with the industry’s 13.3% rise. The company’s earnings beat estimates in the trailing four quarters, the average surprise being 7.4%.

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

This article originally published on Zacks Investment Research (zacks.com).

Zacks Investment Research