Quanterix presents new Alzheimer’s disease data at AAIC

Quanterix presented new data at the Alzheimer’s Association International Conference, or AAIC, supporting a novel multi-marker approach to test for Alzheimer’s disease, or 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 ss 42, amyloid ss 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 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.