FDA Clears Roche And Eli Lilly's Alzheimer's Blood Test

The Food and Drug Administration has cleared a new blood test from Roche and Eli Lilly designed to help identify symptoms related to Alzheimer’s disease in patients over age 55, Roche said on Monday morning.

The FDA cleared the Elecsys Phospho-Tau (217P) Plasma blood test, which Roche and Lilly say is the single-biomarker blood test designed to test for the likelihood of amyloid pathology, a brain symptom linked with Alzheimer’s disease. Doctors could previously diagnose amyloid pathology using PET imaging or cerebrospinal fluid testing—both expensive and invasive procedures.The test was designed to be “minimally invasive” and to work easily beside “existing laboratory workflows,” Roche and Lilly said, and won’t require labs to purchase additional equipment. However, the test was not designed to be a standalone test for Alzheimer’s and should be interpreted for patients with other clinical information. Both Labcorp and Quest Diagnostics, two large companies that offer blood testing services, said they planned to start offering the new test.