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The Elecsys pTau217 test can help doctors assess amyloid pathology in people 55 and older showing signs of cognitive decline
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Roche announced Monday that the U.S. Food and Drug Administration has cleared its Elecsys pTau217 blood test, developed with Eli Lilly $LLY, to help identify amyloid pathology associated with Alzheimer's disease in people 55 and older who show signs or complaints of cognitive decline.
The test is the first FDA-cleared, single-biomarker blood test designed to support both rule-in and rule-out assessment of amyloid pathology using the same validated cutoffs across primary and specialty care settings, the company said. Clinicians receive one of three result categories — positive, negative, or intermediate — and are expected to weigh those findings together with the patient's broader clinical picture rather than treat the test result alone as definitive.
