Labcorp Launches First FDA-Cleared Blood Test For Alzheimer’s Disease

Labcorp announced the availability of the Lumipulse® pTau-217/Beta Amyloid 42 Ratio, the first blood-based in-vitro diagnostic (IVD) test cleared by the U.S. Food and Drug Administration (FDA) to aid in the diagnosis of Alzheimer's disease through early detection. Developed by Fujirebio Diagnostics, Inc., the test is now available nationwide through Labcorp, the announcement stated.

The test offers results that are comparable to existing methods that support a diagnosis of Alzheimer's disease–cerebrospinal fluid (CSF) testing obtained through lumbar puncture and positron emission tomography (PET) scans–but from a simple blood draw, making it . . .