Labcorp Launches FDA-Cleared Blood Test for Early Alzheimer's Detection.

Labcorp has launched a FDA-cleared blood test for Alzheimer's disease, called the Lumipulse pTau-217/Beta Amyloid 42 Ratio. The test aids in early detection of the disease through measurement of tau protein and beta-amyloid levels in the blood. The test is intended for use in diagnosing Alzheimer's disease in symptomatic adults 60 years of age or older.

Labcorp (NYSE: LH), a global leader in innovative and comprehensive laboratory services, has announced the nationwide availability of the Lumipulse® pTau-217/Beta Amyloid 42 Ratio, the first FDA-cleared blood-based in-vitro diagnostic (IVD) test for aiding in the diagnosis of Alzheimer's disease. This test, developed by Fujirebio Diagnostics, Inc., offers a more accessible and less invasive alternative to existing methods such as cerebrospinal fluid (CSF) testing and positron emission tomography (PET) scans [1].

The Lumipulse pTau-217/Beta Amyloid 42 Ratio test is designed for adults aged 50 years and older presenting at a specialized care setting with signs and symptoms of cognitive decline. It is not intended for screening or as a stand-alone diagnostic tool, and results must be interpreted in conjunction with other clinical information [2]. The test demonstrated a positive predictive value of 92% and a negative predictive value of 97% in clinical studies, indicating high accuracy in identifying Alzheimer's disease [1].

Dr. Brian Caveney, chief medical and scientific officer at Labcorp, noted that the test aims to accelerate the diagnostic process and facilitate earlier intervention, clinical trial enrollment, or therapy initiation. This launch coincides with a new clinical guideline from the Alzheimer's Association, which supports the use of blood-based biomarkers for evaluating patients suspected of Alzheimer's disease in specialty care settings [1].

The availability of this test nationwide through Labcorp's extensive network of over 2,200 Patient Service Centers (PSCs) will significantly enhance accessibility for patients and healthcare providers. This development is part of Labcorp's broader strategy to provide innovative solutions for Alzheimer's disease and other neurological conditions [1].

The stock of Labcorp (NYSE: LH) has traded in a range of $209.38 to $283.47 over the past year, with the stock closing at $270.38 on the last trading day [2].

References:
[1] https://www.prnewswire.com/news-releases/labcorp-launches-first-fda-cleared-blood-test-for-alzheimers-disease-302531885.html
[2] https://www.nasdaq.com/articles/first-fda-cleared-blood-test-alzheimers-diagnosis-now-available-us