Lucent Diagnostics, a diagnostics brand of Quanterix Corp., announced the expansion of its LucentAD product line with the addition of a high-accuracy p-Tau 217 blood test for Alzheimer’s disease.
This lab-developed test (LDT), the LucentAD p-Tau 217, marks a major advance in the performance of scalable immunoassay-based blood biomarker tests intended for assessing amyloid pathology in individuals with memory complaints, the company says.
The p-Tau 217 protein 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 company says. 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.
The LucentAD p-Tau 217 Test
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,” says Masoud Toloue, CEO of Quanterix. “The launch of LucentAD p-Tau 217 is an important milestone in our efforts to build broad-based non-invasive testing for amyloid pathology. We believe that Simoa technology offers the world’s only full range scalable clinical solution, overcoming the complexities and limitations of less sensitive single-plexed analog immunoassay platforms that struggle to measure this important biomarker. We will make this test available worldwide to all, in our pursuit of improving access to life changing diagnostics and treatments for the millions of individuals and their families living with Alzheimer’s disease.”
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.
“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,” says Tharick Pascoal MD, PhD (neurologist and Associate Professor of Neurology and Psychiatry at the University of Pittsburgh School of Medicine). “These advances will provide significant benefits to patients, providers, and health systems as new therapies become available.”
Lucent Diagnostics will announce additional tests aimed at improving the diagnosis and management of Alzheimer’s and other neurological disorders. The LucentAD test is available through a healthcare provider’s order.