Labcorp , a global leader in laboratory services, has announced the nationwide availability of the Lumipulse® pTau-217/Beta Amyloid 42 Ratio test, the first FDA-cleared blood-based in-vitro diagnostic (IVD) test to aid in the diagnosis of Alzheimer’s disease. Developed by Fujirebio Diagnostics, Inc., the test helps detect amyloid plaques linked to the disease in appropriate patients.
Unlike traditional methods such as cerebrospinal fluid (CSF) testing or PET scans, this blood test is simpler, more affordable, and less invasive, while providing comparable accuracy. In clinical studies, the test showed a positive predictive value of 92% and a negative predictive value of 97%.
“The path to an Alzheimer’s diagnosis has long involved invasive procedures and costly imaging. This FDA-cleared blood test allows clinicians to diagnose sooner, enabling faster access to clinical trials and therapies,” said Dr. Brian Caveney, Chief Medical and Scientific Officer, Labcorp.
The launch follows the Alzheimer’s Association’s new clinical guidelines, which support the use of blood-based biomarkers in evaluating patients with suspected Alzheimer’s in specialty care settings.
The test is designed for adults aged 50 and older who show symptoms of cognitive decline in specialized care settings. It is not a stand-alone diagnostic tool and must be interpreted alongside other clinical findings. Patients can complete a simple blood draw at a healthcare provider’s office or any of Labcorp’s 2,200+ Patient Service Centers nationwide.
This FDA-cleared version builds on and replaces the earlier pTau-217/Beta Amyloid 42 Ratio test introduced by Labcorp in April 2025.