Lucent Diagnostics, a division of Quanterix Corporation (NASDAQ: QTRX), has launched LucentAD Complete, an innovative multi-marker blood test aimed at enhancing Alzheimer’s Disease (AD) detection across a wider patient population.
Recent guidelines from the Alzheimer’s Association suggest using plasma p-Tau 217 tests with two cutoffs to distinguish between patients with and without amyloid pathology, a key indicator of AD. However, this method leaves an “intermediate zone” of uncertainty, requiring further invasive testing, such as lumbar punctures or costly amyloid PET scans, for affected patients. LucentAD Complete reduces the number of patients falling into this intermediate zone by threefold. It employs a proprietary algorithm that analyzes five AD-related biomarkers (p-Tau 217, Aβ42/40, NfL, GFAP), yielding significantly improved amyloid classification compared to single-marker tests.
“In over 1,000 patients across three independent clinical cohorts, we met guideline performance standards for blood-based Alzheimer’s diagnostics while increasing conclusive results compared to p-Tau 217 alone,” stated Masoud Toloue, CEO of Quanterix. “This confirms our multi-marker strategy as the next evolution in blood testing for AD, and we look forward to presenting our findings at the Clinical Trials on Alzheimer’s Disease (CTAD) conference.”
The development of this test was supported by the Alzheimer’s Drug Discovery Foundation’s Diagnostics Accelerator.
“Alzheimer’s is a complex disease that requires a multi-biomarker approach to detect its various underlying pathologies. Platforms like Quanterix’s Simoa offer a path toward precision medicine,” said Howard Fillit, MD, Co-Founder and Chief Science Officer at the Alzheimer’s Drug Discovery Foundation. “LucentAD’s ability to minimize the intermediate zone in pTau testing reinforces that Alzheimer’s is not defined by a single biomarker.”
Lucent Diagnostics’ tests are developed and validated by Quanterix Corporation (CLIA# 22D1053083) in compliance with CLIA requirements.
About Lucent Diagnostics
Lucent Diagnostics, launched in 2023 as a commercial brand of Quanterix, aims to provide groundbreaking tools for the early detection of cognitive diseases. Utilizing the ultra-sensitive Simoa® technology, Lucent Diagnostics bridges research and clinical application, offering tailored products and services for institutions and healthcare providers. With over a decade of success in neurology research and extensive partnerships, Quanterix is committed to transforming the landscape of cognitive disease through Lucent Diagnostics.
About Quanterix
Quanterix is revolutionizing biomarker detection from discovery to diagnostics with its ultra-sensitive technology. The Simoa® platform sets the standard for early biomarker detection in blood, serum, or plasma, enabling the quantification of proteins at levels below conventional methods’ limits. With industry-leading precision instruments and a CLIA-certified Accelerator laboratory, Quanterix supports research that advances understanding and management across various medical fields, including neurology, oncology, immunology, cardiology, and infectious disease. Quanterix has partnered with the scientific community for nearly two decades, contributing to research published in over 2,900 peer-reviewed journals.