FDA Approves Roche Blood Test for Alzheimer's Signs in People 55 and Older
Roche announced on August 24 that the U. S. Food and Drug Administration approved its Elecsys pTau-217 blood test to detect signs of Alzheimer's disease. The test is intended for people aged 55 and older with cognitive decline symptoms or complaints, and can be used by primary care and specialist physicians. It measures the plasma phosphorylated tau 217 biomarker. Labcorp and Quest Diagnostics will offer the test.
Roche announced on August 24 that the U. S. Food and Drug Administration (FDA) has approved its blood test, Elecsys pTau-217, for detecting signs of Alzheimer's disease. The test is intended for individuals aged at least 55 who are showing signs of cognitive decline or have reported such decline, and it can be used by primary care physicians and specialists. The test measures the plasma phosphorylated tau 217 biomarker.
A study conducted from 2004 to 2025 and published in the Journal of the American Medical Association found that higher levels of this biomarker were associated with an increased risk of progression to cognitive impairment. The FDA has previously approved several other Alzheimer's tests, including one from Fujirebio Diagnostics in 2025 that measures both pTau217 and another protein. Roche said its test is the first of its kind to measure a single biomarker.
Labcorp and Quest Diagnostics said they will offer the test. After a physician orders it, patients can have blood drawn at a doctor's office, a Labcorp service center, or a Quest center. Alzheimer's disease is a brain disorder that progressively destroys memory and thinking abilities, eventually leaving patients unable to perform basic tasks such as eating and walking. Many people begin experiencing symptoms such as memory difficulties between the ages of 60 and 70.