Lucent Diagnostics, a brand of Quanterix, has introduced LucentAD p-Tau 217, its new high-accuracy p-Tau 217 blood test to detect Alzheimer’s disease (AD).
The test expands Lucent’s LucentAD portfolio and advances the scalable immunoassay-based blood biomarker tests for evaluating amyloid pathology in people with memory complaints.
Recently, Quanterix signed a licence agreement with Johnson & Johnson (J&J)’s subsidiary Janssen Sciences Ireland UC, to advance the blood-based testing of AD.
Quanterix has obtained non-exclusive rights to J&J’s p-Tau 217 antibodies and assay designs for potential use in clinical research and diagnostic products.
The LucentAD p-Tau 217 test leverages a combination of Quanterix’ Simoa technology and J&J Innovative Medicine’s p-Tau 217 antibodies to provide high accuracy with a simplified workflow.
Quanterix CEO Masoud Toloue said: “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.”
According to the company, p-Tau 217 has emerged as a top biomarker for assessing Alzheimer’s pathology, with clinical sensitivity and specificity.
Traditional methods such as positron emission tomography (PET) or lumbar puncture for cerebrospinal fluid (CSF) biomarkers are expensive, invasive, and not widely available.
Its LucentAD p-Tau 217 blood test can speed up the diagnosis and expand access to treatments for individuals with early Alzheimer’s disease, said Lucent.
The company said that the test has been validated in a clinical trial cohort comprising more than 500 subjects with subjective cognitive decline, mild cognitive impairment, and early AD.
When compared to the amyloid status determined by CSF biomarker testing, the LucentAD p-Tau 217 test achieved an overall accuracy of more than 90%, said the diagnostics company.
