• Quanterix improves on its best-in-class p-Tau 217 standalone test with new multi-marker approach reducing the number of patients receiving uncertain results

BILLERICA, Mass. / Jul 29, 2024 / Business Wire / Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery through ultrasensitive biomarker detection, today presented new data at the Alzheimer’s Association International Conference (AAIC), supporting a novel multi-marker approach to test for Alzheimer’s disease (AD). For the first time, new data show that applying a combination of AD-relevant biomarkers with p-Tau 217 significantly reduces the intermediate zone of a two-cutoff p-Tau 217 test, while preserving high accuracy above 90%.

Recent Alzheimer’s Association criteria for diagnosing Alzheimer’s recommends that plasma p-Tau 217 tests be designed with two cutoffs to confidently differentiate between patients with or without AD pathology. This two-cutoff approach maximizes the accuracy of a p-Tau 217 test but leaves a zone of intermediate risk between the two cutoffs representing inconclusive borderline amyloid status. It is desirable to reduce this intermediate region while preserving a test’s accuracy to reduce the number of patients receiving inconclusive results.

Quanterix investigated whether interrogating intermediate samples with a panel of additional Alzheimer’s-associated plasma biomarkers, including combinations of amyloid β 42, amyloid β 40, GFAP, and NfL, together with p-Tau 217 in an algorithm that provides a single risk score, would improve the amyloid classification of uncertain results compared to a stand-alone p-Tau 217 test. The research found that this multi-marker approach enabled accurate amyloid classifications for 151 of 228 previously uncertain results across a large, high-diversity cohort of symptomatic individuals, reducing the intermediate zone 3-fold from 31.2% to 10.5% compared to p-Tau 217 alone. This finding highlights a potential key benefit of a multi-marker approach to blood-based Alzheimer’s testing, which is to provide diagnostic certainty for a significantly greater number of patients undergoing evaluation for AD.

“Quanterix’s Simoa technology is an exceptionally sensitive platform, which when combined with our digital p-Tau 217 assay, has provided a result for all samples tested,” said Masoud Toloue, CEO of Quanterix. “In over 2,000 samples tested, our LucentAD p-Tau 217 assay has yet to encounter a single result that is unreadable and combines this sensitivity with an overall accuracy above 90%. With these novel multi-marker results, we are leveraging the best of our p-Tau 217 test along with other AD-relevant biomarkers. We believe that a multi-marker approach is the next phase in the evolution of blood-based testing, not only for identifying and staging Alzheimer’s pathology, but also for informing important differential treatment pathways that include non-Alzheimer’s neurodegenerative diseases. The latter is an important consideration given approximately 30% of Alzheimer’s patients have pathologies other than AD.”

Quanterix is currently investing in further studies to evaluate multi-marker testing and expects to launch a multi-marker laboratory developed test later this year through its LucentAD product line. LucentAD consists of a menu of laboratory developed tests run under CLIA and focused on applications supporting Alzheimer’s diagnosis and treatment.

This work is being presented in a virtual poster entitled, “Multi-Marker Approach to Reducing the Intermediate Range of a High Accuracy 2-Cutoff Plasma p-Tau 217 Test for Amyloid Detection,” poster 95706, throughout AAIC. Quanterix will be at AAIC (7/28 – 8/1) at booth #730. Interested parties can schedule time to meet with Quanterix team members onsite using the event website: (https://www.quanterix.com/conferences/alzheimers-association-international-conference-aaic-2024/).

To learn more about Lucent Diagnostics, visit: https://www.lucentdiagnostics.com/.

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

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.