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FDA Grants Breakthrough Device Designation to Quanterix for Innovative Blood-Based p-Tau 217 Test Targeting Alzheimer's Disease Detection

Quanterix Corporation, a prominent provider of advanced research products and high-definition diagnostics, has announced a significant achievement: its Simoa® phospho-Tau 217 (p-Tau 217) blood test has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). This designation recognizes the test's potential to revolutionize Alzheimer's Disease (AD) diagnostics by addressing an urgent medical need.

p-Tau 217 has emerged as a promising biomarker for detecting Alzheimer's pathology, singled out by the NIA-AA criteria as the primary plasma biomarker for accurately diagnosing amyloid pathology. Traditional diagnostic methods like positron emission tomography (PET) and cerebrospinal fluid (CSF) biomarker analysis are invasive and not always accessible, making the emergence of high-performing blood-based biomarker tests a welcome development for patient care.

Quanterix is at the forefront of AD biomarker research, committed to advancing sensitive assay tests and improving clinical AD diagnostics by making blood biomarker tests more accessible. Early detection is critical for effective care strategies and better patient outcomes, and advancements in blood-based biomarkers owe much to sensitive technologies like Quanterix's Simoa®.

The Simoa p-Tau 217 test, outlined in the Breakthrough Device application, is a semi-quantitative in vitro diagnostic immunoassay intended for measuring p-Tau 217 concentration in plasma using the Quanterix HD-X immunoassay system. Proposed indications include using test results in patients with cognitive impairment undergoing AD risk assessment to aid in diagnostic evaluation. It's important to note that the test is not intended for standalone diagnosis and must be interpreted alongside other diagnostic methods. The Breakthrough Device designation for the p-Tau 217 test underscores its potential to significantly impact AD diagnosis and treatment, offering promise for enhanced patient care and outcomes.


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