FDA Approves New Blood Test for Alzheimer's Disease Detection

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.