Quanterix Announces FDA 510(k) Submission for a Multi-Analyte Algorithmic Blood Test for Alzheimer’s Disease Detection
Quanterix Corporation (QTRX)
US:NASDAQ Investor Relations:
ir.quanterix.com/investor-relations
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Source: Business Wire
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
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News
- Mercy BioAnalytics Appoints Darrin Crisitello as Chief Commercial Officer [Yahoo! Finance]Yahoo! Finance
- Quanterix Announces FDA 510(k) Submission for a Multi-Analyte Algorithmic Blood Test for Alzheimer's Disease Detection [Yahoo! Finance]Yahoo! Finance
- Quanterix Announces Landmark JAMA Study Highlighting Prognostic Value of Multi-Analyte Approach to Blood-Based Alzheimer’s Risk ProfilingBusiness Wire
- Quanterix Corporation Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) [Yahoo! Finance]Yahoo! Finance
- Quanterix Corporation Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)Business Wire
QTRX
Earnings
- 11/10/25 - Miss
QTRX
Analyst Actions
- 12/22/25 - Canaccord Genuity
QTRX
Sec Filings
- 1/21/26 - Form 4
- 1/21/26 - Form 3
- 1/20/26 - Form 4
- QTRX's page on the SEC website