Quanterix Corporation (QTRX) on Tuesday said it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for a multi-analyte algorithmic blood test to detect Alzheimer's disease (AD).
The test is designed to help determine if patients with memory or thinking problems have amyloid brain plaques, a key sign of Alzheimer's, using a simple blood sample. Quanterix said it provides a more comprehensive assessment of the biological factors of Alzheimer's disease than traditional single-analyte assays.
The multi-analyte test had previously received Breakthrough Device Designation from the FDA.
Quanterix shares rose 2.5% to close at $6.50 on Monday.
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