Labcorp Launches FDA-Approved Blood Test for Alzheimer's Diagnosis

Labcorp announced the availability of a blood-based test to aid in the diagnosis of Alzheimer's disease. The Lumipulse pTau-217/Beta Amyloid 42 Ratio test, developed by Fujirebio Diagnostics, has a positive predictive value of 92% and a negative predictive value of 97%. This is the first of its kind test approved by the US FDA. The test is now available nationwide, with Labcorp leading the way in delivering innovative solutions for Alzheimer's disease and other neurological conditions.

Labcorp (NYSE: LH) has announced the nationwide availability of the Lumipulse® pTau-217/Beta Amyloid 42 Ratio test, 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 [1]. Developed by Fujirebio Diagnostics, Inc., the test offers results comparable to existing methods such as cerebrospinal fluid (CSF) testing and positron emission tomography (PET) scans, but from a simple blood draw, making it more affordable, accessible, and less invasive.

The Lumipulse pTau-217/Beta Amyloid 42 Ratio test demonstrated a positive predictive value of 92% and a negative predictive value of 97% in clinical studies [2]. It is intended for adults aged 50 years and older presenting at a specialized care setting with signs and symptoms of cognitive decline. The test is not a stand-alone diagnostic tool and must be interpreted in conjunction with other clinical information.

The launch of this test follows 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 [1]. The guideline highlights the growing clinical consensus around these tools and reinforces the importance of expanding access.

Labcorp, a global leader in innovative and comprehensive laboratory services, offers this test through its extensive network of more than 2,200 Patient Service Centers (PSCs) nationwide. The test builds on and replaces a similar pTau-217/Beta Amyloid 42 Ratio test that Labcorp launched in April 2025 [2].

References:
[1] https://finance.yahoo.com/news/labcorp-launches-first-fda-cleared-110000976.html
[2] https://www.prnewswire.com/news-releases/labcorp-launches-first-fda-cleared-blood-test-for-alzheimers-disease-302531885.html