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FDA Approves New Blood Test for Alzheimer's Disease Detection

Health7 sourcesAug 25, 2026
ContestedRigor 517 sources

The Story

The U.S. Food and Drug Administration (FDA) approved a new blood test to detect signs of Alzheimer’s disease. Roche announced Sunday that the FDA granted approval to its Elecsys Phospho-Tau blood test for diagnosing Alzheimer’s disease. This marks the fourth such blood test approved in less than two years. The FDA cleared the Elecsys Phospho-Tau (217P) Plasma blood test, developed by Roche and Eli Lilly, on Monday. Roche and Lilly state this is a single-biomarker blood test designed to test for the likelihood of amyloid pathology, a brain symptom linked with Alzheimer’s disease. The test is designed to help identify symptoms related to Alzheimer’s disease in patients over age 55. Doctors previously diagnosed amyloid pathology using PET imaging or cerebrospinal fluid testing, which are described as expensive and invasive procedures. The new test is designed to be minimally invasive and to work easily alongside existing laboratory workflows, not requiring labs to purchase additional equipment, according to Roche and Lilly. However, the test is not designed to be a standalone diagnostic for Alzheimer’s and should be interpreted for patients with other clinical information. Both Labcorp and Quest Diagnostics, large companies offering blood testing services, plan to offer the new test. The FDA previously cleared the first blood test for Alzheimer’s last May. That test, developed by Japanese biotech firm Fujirebio, also tests for amyloid plaques in plasma and can reliably predict amyloid pathology. The Centers for Disease Control and Prevention estimates 6.7 million older adults live with diagnosed Alzheimer’s disease in the U.S., making it the most common form of dementia, comprising 60% to 80% of all cases. The CDC projects this figure will double by 2060.

The Spread

What they agree on

  • The U.S. Food and Drug Administration (FDA) approved a new blood test for Alzheimer's disease.
  • The approved test is the Elecsys Phospho-Tau (217P) Plasma blood test, developed by Roche and Eli Lilly.
  • The test is designed to identify the likelihood of amyloid pathology, a brain symptom linked with Alzheimer’s disease.
  • This is the fourth blood test for Alzheimer's disease approved by the FDA in less than two years.
  • The test is intended for patients over age 55 and is not a standalone diagnostic for Alzheimer's.

Where they split

  • The Washington Post and The Hill lead with the general FDA approval of "a new blood test" for Alzheimer's, while CNN, Forbes, and The Wall Street Journal specifically name Roche and Eli Lilly in their headlines.
  • Forbes provides details on the test's design, stating it is "minimally invasive" and will not require labs to purchase additional equipment, a detail not present in other headlines or leads.
  • Medical Xpress (2026-08-24T11:00) focuses on the FDA clearing the PrecivityAD2 test, developed at Washington University School of Medicine, which is a different test than the Roche/Eli Lilly test emphasized by other outlets.
  • ScienceAlert and Medical Xpress (2026-08-25T01:20) discuss broader research topics related to Alzheimer's, such as potential transmission through blood transfusions or early detection via walking patterns, which are outside the scope of the FDA approval of a specific blood test.

Source Perspectives

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