Labcorp to offer FDA-cleared Alzheimer's blood test nationwide
Labcorp (NYSE: LH) announced it will offer the Elecsys® pTau-217 blood test, developed by Roche Diagnostics, following clearance by the U.S. Food and Drug Administration.
According to a company statement, the test is intended for individuals 55 and older who show signs, symptoms, or complaints of cognitive decline. It measures phosphorylated Tau 217 (pTau-217), a biomarker associated with amyloid pathology linked to Alzheimer's disease.
Labcorp describes the Elecsys® pTau-217 as the first and only FDA-cleared single-biomarker blood test capable of both ruling in and ruling out amyloid pathology across primary and specialty care settings. The test uses the same clinical cutoffs in both settings and delivers positive, intermediate, and negative result categories.
The company said patients can have blood drawn at a physician's office or at one of Labcorp's more than 2,200 patient service centers. Labcorp plans to make the test available nationwide in the coming months.
The Elecsys® pTau-217 joins Labcorp's existing Alzheimer's testing portfolio, which includes the FDA-cleared Elecsys® pTau-181 test and the Lumipulse® pTau-217/Beta-Amyloid 42 Ratio test.
