Roche announces FDA clearance of Elecsys pTau217 blood test
Roche announced that the U.S. FDA has cleared the Elecsys Phospho-Tau (217P) Plasma (pTau217) blood test, a single-biomarker assay developed with Eli Lilly to aid identification of amyloid pathology in individuals aged 55 and older with cognitive decline. Roche states the test is the first and only FDA-cleared single-biomarker blood test to support both rule-in and rule-out assessment using the same validated clinical cutoffs and is designed for use across Roche's more than 4,500 cobas laboratory instruments in the U.S.
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