Summary: Lucent Diagnostics has launched LucentAD Complete, a blood test using five Alzheimer’s-related biomarkers to improve detection accuracy and reduce the need for invasive testing.
Takeaways:
- Enhanced Detection Accuracy: LucentAD Complete combines five biomarkers to reduce ambiguous results, improving amyloid classification over single-marker tests.
- Reduced Invasive Testing Needs: The test minimizes the “intermediate zone” that often necessitates follow-up with lumbar punctures or costly PET scans, offering a less invasive diagnostic approach.
- Validated Across Multiple Cohorts: Tested on over 1,000 patients, LucentAD Complete meets performance guidelines for blood-based Alzheimer’s diagnostics, signaling a breakthrough in AD screening and early detection.
Lucent Diagnostics, a brand of Quanterix Corporation, has introduced LucentAD Complete, a new multi-marker blood test designed to help detect Alzheimer’s Disease (AD) in a broader range of patients.
Improving Alzheimer’s Diagnosis
Recent Alzheimer’s Association criteria for diagnosing Alzheimer’s recommend that plasma p-Tau 217 tests be designed with two cutoffs to confidently differentiate between patients with or without amyloid pathology, a hallmark of AD. However, this approach leaves an “intermediate zone” of uncertainty, requiring patients that fall into this zone follow up with cerebral spinal fluid measurement via invasive lumbar puncture or costly amyloid PET scans.
LucentAD Complete addresses this by reducing the number of patients that fall into the intermediate zone by threefold. The test uses a proprietary algorithm to score five AD-related biomarkers (p-Tau 217, Aβ42/40, NfL, GFAP) providing significantly better amyloid classification compared to single-marker tests alone.
Further reading: Mount Sinai Expands Early Alzheimer’s Detection with Blood-Based Biomarkers
The LucentAD Complete Test
“In over 1,000 patients across three independent clinical cohorts, we achieved guideline performance standard for a blood-based Alzheimer’s diagnostic test, while significantly increasing conclusive results for more patients versus p-Tau 217 alone,” says Masoud Toloue, CEO of Quanterix. “This test confirms our multi-marker approach as the next phase in the evolution of blood-based testing for AD, and we are excited to present our results at the Clinical Trials on Alzheimer’s Disease (CTAD) conference.”
The test development was funded by the Alzheimer’s Drug Discovery Foundation’s Diagnostics Accelerator.
“Alzheimer’s is a multifaceted disease and as such, we will need a multi biomarker approach to detect the various underlying pathologies. Multiplex platforms, like Quanterix’s Simoa platform, offer the potential to move us closer to a precision medicine approach,” says Howard Fillit, MD, co-founder and chief science officer at Alzheimer’s Drug Discovery Foundation. “The ability of LucentAD’s test to reduce the intermediate zone of pTau testing further demonstrates that Alzheimer’s is not a single biomarker disease.”