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Quanterix Launches High Accuracy p-Tau 217 Blood Biomarker Test to Aid Physician Diagnosis of Alzheimer’s Disease
New test elevates the performance standard for blood biomarker tests intended for detecting amyloid pathology in individuals with cognitive impairment
About this update from Quanterix Corporation
[{"type":"text","content":"\nNew test elevates the performance standard for blood biomarker tests intended for detecting amyloid pathology in individuals with cognitive impairment\n\n\n BILLERICA, Mass.--(BUSINESS WIRE)--\nLucent Diagnostics, a diagnostics brand of Quanterix Corporation (NASDAQ: QTRX), today announced expansion of its LucentAD product line with the addition of a high accuracy p-Tau 217 blood test for Alzheimer’s disease – LucentAD p-Tau 217. This lab developed test marks a major advance in the performance of scalable immunoassay-based blood biomarker tests intended for assessing amyloid pathology in individuals with memory complaints.\n\n\np-Tau 217 has emerged as a top performing biomarker for Alzheimer’s pathology, enabling clinical sensitivity and specificity in blood. Traditional methods include positron emission tomography (PET) or lumbar puncture for cerebrospinal fluid (CSF) biomarkers, which are expensive, invasive, and lack wide availability. The recent approval of new therapies has highlighted an urgent need for improved diagnostic methods. Highly sensitive and specific blood-based biomarker tests have the potential to speed diagnosis and expand access to treatments for millions of individuals with early Alzheimer’s disease.\n\n\nLucentAD p-Tau 217 leverages the combination of Quanterix’s ultra-sensitive Simoa® technology and J&J Innovative Medicine’s extensively studied p-Tau 217 antibodies to provide high accuracy with a simplified workflow. Samples can be shipped unfrozen to the Lucent laboratory in packaging provided by Lucent, streamlining the testing process for providers. Training and clinical validation were performed in a combined cohort of over 500 subjects with a range of cognitive status, including subjective cognitive decline, mild cognitive impairment, and early AD. The validation compared the test output to amyloid status determined by CSF biomarker testing. The LucentAD p-Tau 217 test achieved an overall accuracy exceeding 90%, which meets the stringent requirements set forth in the most recent NIA-AA Revised Criteria for Diagnosis and Staging of Alzheimer's Disease. Furthermore, the NIA-AA criteria identify p-Tau 217 as the only plasma biomarker appropriate for accurately diagnosing amyloid pathology.\n\n\n“The LucentAD p-Tau 217 test provides industry leading performance combined with a simplified workflow for ...