Another Alzheimer’s blood test gets OK from FDA | CNN

The US Food and Drug Administration has cleared Roche and partner Eli Lillyâs blood test to help âidentify signs of Alzheimerâs disease in people age â55 and older with cognitive decline. The test, Elecsys pTau217, is a biomarker blood test that can help doctors identify patients who are âlikely or unlikely to have Alzheimerâs-related brain changes, âRoche said Monday. The FDA clearance follows European â approval for the test in May. The test can be ârun on more than 4,500 Roche laboratory analyzers already installed âacross the United States, which the company said could help broaden access. Labcorp and Quest Diagnostics have said they plan to offer âthe test through their laboratory networks, potentially expanding availability. Roche did not disclose the testâs price. The FDA clearance âcomes as â drugmakers and diagnostic companies race to develop simpler tests for Alzheimerâs disease to meet growing âdemand for earlier diagnosis and treatment. Fujirebioâs Lumipulse became âthe â first blood test cleared by the FDA to aid in the assessment of Alzheimerâs disease in 2025. Roche and Lillyâs Elecsys pTau181 test, which measures a different pr
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