Labcorp launches first FDA-cleared blood test for Alzheimer’s disease

Labcorp (LH) announced the availability of the Lumipulse pTau-217/Beta Amyloid 42 Ratio, the first blood-based in-vitro diagnostic test cleared by the U.S. FDA to aid in the diagnosis of Alzheimer’s disease through early detection of the amyloid plaques associated with the disease in appropriate patients. Developed by Fujirebio Diagnostics, the test is now available nationwide through Labcorp. The test offers results that are comparable to existing methods that support a diagnosis of Alzheimer’s disease – cerebrospinal fluid testing obtained through lumbar puncture and positron emission tomography scans – but from a simple blood draw, making it more affordable, more accessible and less invasive. Fujirebio reports that in clinical studies, the test demonstrated a positive predictive value of 92% and a negative predictive value of 97%.