Roche announced on Monday that the U.S. Food and Drug Administration has granted approval for its Elecsys pTau217 blood test, designed to aid in the evaluation of Alzheimer's disease in adults aged 55 and older presenting signs of cognitive decline.
The test, developed in collaboration with Eli Lilly, is the first FDA-cleared single-biomarker blood assay capable of indicating both the presence and absence of amyloid pathology, a hallmark of Alzheimer's disease. Roche stated the diagnostic tool is intended to streamline Alzheimer's assessment in primary care and specialist settings.
The Elecsys pTau217 test measures the protein Phospho-Tau 217 (pTau217), a biomarker linked to Alzheimer's-associated amyloid pathology. Current diagnostic methods, including PET scans and cerebrospinal fluid analysis, are typically more complex, costly, or invasive, according to Roche. The company did not disclose financial terms related to the test's development or commercialization.
