Labcorp launches first FDA-cleared blood test for Alzheimer’s disease

Published 18/08/2025, 12:10
Labcorp launches first FDA-cleared blood test for Alzheimer’s disease

BURLINGTON, N.C. - Labcorp (NYSE:LH), a prominent $22.5 billion healthcare services provider with a strong financial health rating according to InvestingPro, announced Monday the nationwide availability of the Lumipulse pTau-217/Beta Amyloid 42 Ratio, the first blood-based test cleared by the U.S. Food and Drug Administration to aid in diagnosing Alzheimer’s disease.

The test, developed by Fujirebio Diagnostics, Inc., detects amyloid plaques associated with Alzheimer’s through a simple blood draw, offering a less invasive alternative to traditional diagnostic methods such as cerebrospinal fluid testing and PET scans.

According to clinical studies cited in the press release, the test demonstrated a positive predictive value of 92% and a negative predictive value of 97%.

"The path to an Alzheimer’s diagnosis has long meant a diagnostic journey requiring years of invasive procedures and expensive imaging," said Dr. Brian Caveney, chief medical and scientific officer at Labcorp.

The test is intended for adults aged 50 and older who show signs of cognitive decline in specialized care settings. It is not designed as a standalone diagnostic tool and must be interpreted alongside other clinical information.

This launch follows the recent release of new clinical guidelines from the Alzheimer’s Association supporting the use of blood-based biomarkers for evaluating patients suspected of having Alzheimer’s disease in specialty care settings.

Patients can access the test through a healthcare provider’s order and complete the blood draw at any of Labcorp’s more than 2,200 Patient Service Centers nationwide.

The FDA-cleared test replaces a similar ratio test that Labcorp launched in April 2025, according to the company’s statement.

In other recent news, Laboratory Corporation of America reported strong financial results for the second quarter of 2025, with an adjusted earnings per share (EPS) of $4.35, surpassing the anticipated $4.17. The company also exceeded revenue expectations, recording $3.53 billion compared to the projected $3.48 billion. Following these results, Jefferies raised its price target for the company to $300, maintaining a Buy rating, highlighting a 1% top-line beat driven by its Base Business segment. Evercore ISI also increased its price target to $300, emphasizing the company’s solid second-quarter performance and strong diagnostic growth from organic sources and acquisitions. Additionally, Leerink Partners raised its price target to $323, citing an impressive earnings season for Labcorp’s diagnostics business and biopharma laboratory services division. These developments reflect the positive outlook from various analysts on Labcorp’s recent performance.

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