Quanterix launches diagnostic test aiding early Alzheimer’s detection

Quanterix, a biomarker detection firm powering scientific research and breakthrough diagnostics, has introduced LucentAD, a new test designed to aid in the evaluation of patients exhibiting cognitive symptoms indicative of early Alzheimer’s disease (AD).

This test allows healthcare providers to quickly assess the likelihood of a patient exhibiting amyloid pathology, a significant marker of Alzheimer’s disease, providing a convenient tool for use alongside other diagnostic methods.

Operated from Quanterix‘s CLIA laboratory, the LucentAD test is geared to support the medical trials related to Alzheimer’s. Quanterix has also launched Lucent Diagnostics, a portal facing healthcare providers, responding to patient needs at a time when therapy for the disease is becoming more accessible.

The LucentAD test gauges the concentration of an isoform of phosphorylated tau protein in plasma (p-Tau 181), a marker associated with the presence of amyloid pathology in the brain.

The LucentAD leverages the Simoa p-Tau 181 assay, which has undergone thorough examination in large longitudinal and cross-sectional cohorts. This assay demonstrates high specificity for amyloid pathology for AD, having been validated against the gold standard for AD diagnosis, amyloid positron emission tomography.

Masoud Toloue — Quanterix CEO said: “A year ago, Quanterix announced the validation of our laboratory developed test to quantitatively measure p-Tau 181 in plasma as an aid in diagnostic evaluation of Alzheimer’s disease.

“The launch of Lucent Diagnostics and availability of the LucentAD test expands access to our p-Tau 181 test for healthcare providers and marks an important step in our goal to help build a global Alzheimer’s disease testing infrastructure.”

The recent findings also show correlation of Simoa plasma p-Tau 181 measurements with the reduction in amyloid load in the brains of patients on anti-amyloid drug therapy, as demonstrated in the lecanemab (Leqembi) Clarity AD drug trial.

The unveiling of LucentAD aligns with the exciting advancements in AD treatment and discovery, particularly the recent FDA full approval of Leqembi, the first disease-modifying drug for Alzheimer’s. This approval was expedited earlier this year based on compelling early clinical trial data.

The plasma p-Tau 181 biomarker, measured using Quanterix’s Simoa platform, was among several biomarkers used to monitor response to therapy, as specified in the Leqembi accelerated approval labelling.

In the coming times, Lucent Diagnostics plans to introduce more tests aimed at improving the diagnosis and management of Alzheimer’s and other neurological disorders. Currently, the LucentAD test is available through an order from a healthcare provider.