The U.S. Food and Drug Administration (FDA) has approved Roche and Eli Lilly’s blood test, Elecsys pTau217. This test helps identify Alzheimer’s disease in people aged 55 and older who show signs of cognitive decline. The approval was announced on Monday and follows the test's earlier approval in Europe in May. The test can be performed on over 4,500 Roche laboratory analyzers already in use across the United States. Roche stated this could improve access to the test.
Key Details
Labcorp and Quest Diagnostics plan to offer Elecsys pTau217 through their lab networks, which could increase its availability. Roche has not shared the test's price. The FDA's approval comes as demand grows for simpler ways to diagnose Alzheimer’s. Traditional methods, like positron emission tomography (PET) scans and spinal taps, can be costly and invasive.
Background
Fujirebio's Lumipulse was the first blood test cleared by the FDA for Alzheimer’s assessment in 2025. Roche noted that Elecsys pTau217 is not meant to be a standalone diagnostic tool. Results should be interpreted with other clinical information. Rachel Buckley, an associate professor of neurology at Harvard Medical School, said tests measuring phosphorylated tau 217 (p-tau217) can strongly predict the buildup of beta-amyloid plaques in the brain. These plaques are linked to Alzheimer’s disease.
The approval of the Elecsys pTau217 test could affect healthcare stocks, especially those of Roche and Eli Lilly. Companies involved in diagnostic testing may also see an impact. The move towards less invasive testing methods may lead to higher demand for such products in healthcare. Investors will look for more updates on the test's integration into clinical practice and its pricing strategy.
Based on reporting by: us.cnn.com, cnn.com