Labcorp Launches First FDA-Cleared Blood Test for Alzheimer's Disease

Core Insights - Labcorp has launched the Lumipulse® pTau-217/Beta Amyloid 42 Ratio, the first FDA-cleared blood-based IVD test for aiding in the diagnosis of Alzheimer's disease through early detection of amyloid plaques [1][2] - The test is designed to be more affordable, accessible, and less invasive compared to traditional methods like cerebrospinal fluid testing and PET scans, with a positive predictive value of 92% and a negative predictive value of 97% [2][3] - The launch aligns with new clinical guidelines from the Alzheimer's Association, emphasizing the importance of blood-based biomarkers in evaluating suspected Alzheimer's patients [3] Company Overview - Labcorp is a global leader in laboratory services, providing insights and advancing science to improve health, with nearly 70,000 employees serving clients in approximately 100 countries [5] - The company supports over 75% of new drugs and therapeutic products approved by the FDA in 2024 and performs more than 700 million tests annually [5] Test Details - The Lumipulse pTau-217/Beta Amyloid 42 Ratio is intended for adults aged 50 and older showing cognitive decline symptoms and must be interpreted alongside other clinical information [4] - Patients can have the blood draw done at healthcare provider offices or any of Labcorp's over 2,200 Patient Service Centers nationwide [4]