The test offers a less invasive alternative to cerebrospinal fluid testing and PET scans for detecting amyloid plaques.
Labcorp has launched the first US Food and Drug Administration (FDA)-cleared blood test for Alzheimer’s disease, Lumipulse pTau-217/Beta Amyloid 42 Ratio, a blood-based in-vitro diagnostic test to aid in the diagnosis of Alzheimer’s disease through early detection of the amyloid plaques associated with the disease in appropriate patients.
The Lumipulse pTau-217/Beta Amyloid 42 Ratio, developed by Fujirebio Diagnostics Inc, is now available nationwide through Labcorp’s network.
Fujirebio reports that, in clinical studies, the test demonstrated a positive predictive value of 92% and a negative predictive value of 97%. The performance matches existing diagnostic methods including cerebrospinal fluid testing obtained through lumbar puncture and positron emission tomography scans, while offering greater affordability and accessibility.
“The path to an Alzheimer’s diagnosis has long meant a diagnostic journey requiring years of invasive procedures and expensive imaging,” says Dr Brian Caveney, chief medical and scientific officer at Labcorp, in a release. “Clinicians need better ways to diagnose their patients more quickly, enroll them in clinical trials, or start therapies.”
Regulatory and Clinical Context
The launch follows the recent release of clinical guidelines from the Alzheimer’s Association supporting blood-based biomarkers for evaluating patients suspected of having Alzheimer’s disease in specialty care settings. The guidelines reflect growing clinical consensus around these diagnostic tools and emphasize expanding access.
The FDA-cleared test is intended for adults aged 50 years and older presenting at specialized care settings with signs and symptoms of cognitive decline. It is not designed as a screening or standalone diagnostic test and must be interpreted alongside other clinical information.
Patients can complete the blood draw at healthcare provider offices or any of Labcorp’s more than 2,200 Patient Service Centers nationwide. The test builds on and replaces a similar pTau-217/Beta Amyloid 42 Ratio test that Labcorp launched in April 2025.
“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,” says Caveney in a release.
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