Labcorp, a global leader of innovative and comprehensive laboratory services, has announced the nationwide availability of the Lumipulse pTau-217/Beta Amyloid 42 Ratio, the first blood-based in-vitro diagnostic (IVD) test cleared by the US Food and Drug Administration (FDA) to aid in the diagnosis of Alzheimer's disease.

Developed by Fujirebio Diagnostics, Inc., the test can detect amyloid plaques associated with Alzheimer's disease in appropriate patients.   

It 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.

In clinical studies, Fujirebio reported a 92 percent positive predictive value and a 97 percent negative predictive value.

"The path to an Alzheimer's diagnosis has long meant a diagnostic journey requiring years of invasive procedures and expensive imaging. 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,” said Dr. Brian Caveney, chief medical and scientific officer at Labcorp.

The launch of this test follows the release of a new clinical guideline from the Alzheimer's Association, which supports the use of blood-based biomarkers to help evaluate patients suspected of Alzheimer's disease in specialty care settings.

The Lumipulse pTau-217/Beta Amyloid 42 Ratio is intended for adults aged 50 years and older presenting at a specialized care setting with signs and symptoms of cognitive decline. It is not intended as a screening or stand-alone diagnostic test and must be interpreted in conjunction with other clinical information of the patient.

The FDA-cleared test builds on and replaces a similar pTau-217/Beta Amyloid 42 Ratio test that the company introduced in April 2025.