Labcorp推出FDA批准的阿尔茨海默病血液检测

2025-08-18 19:52

Labcorp (NYSE:LH) announced on Monday the availability of the Lumipulse pTau-217/Beta Amyloid 42 Ratio, a blood-based in-vitro diagnostic test cleared by the U.S. Food and Drug Administration 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 (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 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.

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