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

BURLINGTON, N.C., Aug. 18, 2025 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today 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.

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 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%.

“The path to an Alzheimer’s diagnosis has long meant a diagnostic journey requiring years of invasive procedures and expensive imaging,” said Dr. Brian Caveney, chief medical and scientific officer at Labcorp. “Clinicians need better ways to diagnose their patients more quickly, enroll them in clinical trials, or start therapies. By offering this FDA-cleared blood test nationwide, Labcorp is leading the way in delivering innovative solutions for Alzheimer’s disease and other neurological conditions by helping patients, families and physicians get answers sooner.” 

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