Roche, which currently has investigational Alzheimer’s disease drug trontinemab in phase 3 trials, has secured FDA clearance of its blood-based biomarker test for the condition.
The minimally invasive Elecsys pTau181 test was developed in collaboration with Eli Lilly. It’s designed to help assess early signs of Alzheimer’s and other causes of cognitive decline in primary care settings for patients 55 years and older, by ruling out Alzheimer’s-related amyloid pathology, according to an Oct. 13 release.
Roche said it currently has more than 4,500 instruments in U.S. clinical labs that can handle the new blood test, giving primary care clinicians a jump on early diagnoses that could lead to improved treatments.
Alzheimer’s impacts more than 7 million Americans and has multiple pathologies, contributing to the estimated 92% of patients with mild cognitive impairment who go undiagnosed, per Roche.
“By bringing Alzheimer’s blood-based biomarker testing into primary care, we can help patients and their clinicians get answers sooner to support them earlier in their journeys,” Brad Moore, Roche’s president and CEO of North American diagnostics, said in the release.
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The test—touted by the company as the first of its kind—measures phosphorylated Tau (pTau) 181 protein in human plasma, which is a key biomarker for Alzheimer’s pathology, including amyloid plaque and tau aggregate pathology.
The FDA clearance comes in the wake of the test garnering CE mark certification in Europe in July.
Earlier this month, Lilly called for European countries to make urgent improvements to their Alzheimer’s disease diagnostic testing practices. That callout came after the company received new approval on the continent for its Alzheimer’s therapy Kisunla, which was approved stateside last year.