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
p-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.
LucentAD 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.
“The LucentAD p-Tau 217 test provides industry leading performance combined with a simplified workflow for the provider,” said
“LucentAD p-Tau 217 has the potential to dramatically change the clinical workflow for diagnosing and treating Alzheimer’s patients. High accuracy blood biomarker tests can reduce the reliance on PET and CSF testing availability and simplify the process of determining the presence of AD pathophysiology,” said Tharick Pascoal MD, PhD (neurologist and Associate Professor of Neurology and Psychiatry at the
The LucentAD product line consists of a menu of laboratory developed tests run under CLIA and focused on applications supporting Alzheimer’s diagnosis and treatment.
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For more information about Quanterix’s work in neurology, visit: https://www.quanterix.com/therapeutic-areas/neurology/.
The LucentAD test was developed and validated by
The Lucent test measures tau protein phosphorylated at threonine 217. Circulating levels of p-Tau 217 have been shown to be a marker of Alzheimer’s Disease (AD) pathology. The test results are intended as an aid in the diagnostic evaluation of AD, to be used in adults presenting with cognitive impairment who are being evaluated for AD. LucentAD test results must be interpreted in conjunction with other diagnostic tools. This test is not intended as a standalone screening or diagnostic assay.
Committed to transforming the landscape of Alzheimer’s Disease (AD) diagnostic testing,
From discovery to diagnostics, Quanterix’s ultrasensitive biomarker detection is fueling breakthroughs only made possible through its unparalleled sensitivity and flexibility. The Company’s Simoa® technology has delivered the gold standard for earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins that are far lower than the Limit of Quantification (LoQ) of conventional analog methods. Its industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology and infectious disease.
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