Labcorp now offers blood-based test for Alzheimer's disease nationwide.

Labcorp announces the availability of the Lumipulse pTau-217/Beta Amyloid 42 Ratio, a blood-based in-vitro diagnostic test cleared by the FDA for early detection of Alzheimer's disease. Developed by Fujirebio Diagnostics, the test is now available nationwide through Labcorp, offering comparable results to existing methods like CSF testing and PET scans, but from a simple blood draw, making it more affordable and accessible.

Labcorp (NYSE: LH) has announced the nationwide availability of the Lumipulse® pTau-217/Beta Amyloid 42 Ratio, the first FDA-cleared blood test for the early detection of Alzheimer's disease. Developed by Fujirebio Diagnostics, this groundbreaking test offers comparable diagnostic accuracy to traditional methods such as cerebrospinal fluid (CSF) testing and positron emission tomography (PET) scans, but through a simpler, more affordable, and less invasive blood draw.

The Lumipulse® pTau-217/Beta Amyloid 42 Ratio demonstrated a 92% positive predictive value and a 97% negative predictive value in clinical studies, according to Labcorp [1]. This test is designed for adults aged 50 and older presenting with symptoms of cognitive decline in specialized care settings. It is not intended as a screening test or stand-alone diagnostic but must be interpreted in conjunction with other clinical information.

The test's significance lies in its potential to accelerate Alzheimer's diagnosis and treatment initiation, overcoming barriers posed by traditional diagnostic methods. Labcorp's extensive nationwide distribution network of over 2,200 Patient Service Centers (PSCs) facilitates rapid market penetration, ensuring that the test is widely accessible [2].

The launch of this test aligns with new Alzheimer's Association clinical guidelines that support the use of blood-based biomarkers in specialty care settings. This regulatory and clinical endorsement strengthens the market positioning and adoption potential of the Lumipulse® pTau-217/Beta Amyloid 42 Ratio test.

Labcorp's progressive improvement in its diagnostic portfolio, with the replacement of its earlier version launched in April 2025, underscores its commitment to innovation and patient care. For patients aged 50 and older experiencing cognitive decline, this test offers a less invasive and more affordable diagnostic tool while maintaining clinical accuracy.

References:
[1] https://www.stocktitan.net/news/LH/labcorp-launches-first-fda-cleared-blood-test-for-alzheimers-disease-a9t0kgzeby3v.html
[2] https://www.prnewswire.com/news-releases/labcorp-launches-first-fda-cleared-blood-test-for-alzheimers-disease-302531885.html