LucentAD^TM Complete improves on single biomarker tests, significantly reducing the intermediate zone, providing results for more patients

Lucent Diagnostics, a brand of Quanterix Corporation (NASDAQ: QTRX), has introduced LucentAD Complete, a new multi-marker blood test designed to help detect Alzheimer’s Disease (AD) in a broader range of patients.

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.

“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,” said 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,” said 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.”

Healthcare providers interested in learning more about Lucent Diagnostics or how to access LucentAD Complete, please visit: https://www.lucentdiagnostics.com/

For more information about Quanterix’s work in neurology, visit: https://www.quanterix.com/therapeutic-areas/neurology/.

The Lucent Diagnostics’ tests have been developed and validated by Quanterix Corporation (CLIA# 22D1053083) in a manner consistent with CLIA requirements.

About Lucent Diagnostics

Lucent Diagnostics, a commercial brand of Quanterix, was created in 2023 to deliver revolutionary tools that aid in the earlier detection of cognitive disease. Powered by the ultra-sensitive Simoa® technology, Lucent Diagnostics bridges the gap between research and clinical use by offering products and services designed specifically to meet the separate needs of institutions and healthcare providers. With more than a decade of proven success within the neurology research space, supported by thousands of publications and partnerships, Quanterix aims to directly impact the landscape of cognitive disease through its commercial brand, Lucent Diagnostics. For more information, please visit www.LucentDiagnostics.com

About Quanterix

From discovery to diagnostics, Quanterix’s ultrasensitive biomarker detection is fueling breakthroughs only made possible through its unparalleled sensitivity and flexibility. The Company’s Simoa® technology has delivered the gold standard for earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins that are far lower than the Limit of Quantification (LoQ) of conventional analog methods. Its industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology and infectious disease. Quanterix has been a trusted partner of the scientific community for nearly two decades, powering research published in more than 2,900 peer-reviewed journals. Find additional information about the Billerica, Massachusetts-based company at https://www.quanterix.com or follow us on Twitter and LinkedIn.

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