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0.000711743772241978 0.000355871886120926 0.00355871886120989 0.00355871886120989 -0.0217081850533808 -0.0106761565836299 -0.0158362989323844 -0.0277580071174378
Stock impact report

Quanterix Granted Breakthrough Device Designation from U.S. FDA for Blood-Based p-Tau 217 Test for Alzheimer's Disease [Yahoo! Finance]

Quanterix Corporation (QTRX) 
US:NASDAQ Investor Relations: ir.quanterix.com/investor-relations
Company Research Source: Yahoo! Finance
high-definition diagnostics, announced today that its Simoa ® phospho-Tau 217 (p-Tau 217) blood test has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) as an aid in diagnostic evaluation of Alzheimer's Disease (AD). The FDA's Breakthrough Device designation is granted to products that have the potential to offer more effective diagnosis of life-threatening diseases with an unmet medical need. p-Tau 217 has emerged as a top-performing biomarker for Alzheimer's pathology, with the NIA-AA criteria identifying p-Tau 217 as the only plasma biomarker appropriate for accurately diagnosing amyloid pathology. Given that traditional testing methods of positron emission tomography (PET) or lumbar puncture for cerebrospinal fluid (CSF) biomarkers are invasive and commonly inaccessible, high-performing blood-based biomarker tests may be an appropriate alternative for patient care. As a pioneer in the AD biomarker field, Quanterix is dedicated to the d Show less Read more
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