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.

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