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

Reuters02-03 21:33

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

Quanterix Corporation has announced the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its multi-analyte algorithmic blood test designed for Alzheimer's disease detection. The test, which previously received Breakthrough Device Designation from the FDA, utilizes Quanterix's Simoa® technology to measure five key biomarkers associated with Alzheimer's disease. The submission represents a step toward regulatory review aimed at providing a non-invasive diagnostic tool to aid in evaluating patients with cognitive symptoms for possible Alzheimer's disease. No other beneficiary organizations were mentioned.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Quanterix Corporation published the original content used to generate this news brief via Business Wire (Ref. ID: 20260203562016) on February 03, 2026, and is solely responsible for the information contained therein.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

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