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Labcorp Launches First-of-its-Kind Immunoassay to Accelerate Path to Diagnosis of Alzheimer's Disease

02 Apr 2025

Labcorp's pTau-217/Beta Amyloid 42 Ratio blood test meets the performance criteria to confirm amyloid pathology consistent with Alzheimer's disease

BURLINGTON, N.C., April 2, 2025 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the nationwide launch of its pTau-217/Beta Amyloid 42 Ratio, a powerful new blood-based biomarker test to aid in the diagnosis of Alzheimer's disease. The new test further expands Labcorp's leading blood-based biomarker portfolio for Alzheimer's disease and dementia.

The pTau-217/Beta Amyloid 42 Ratio supports neurologists, dementia specialists and their patients by offering results that are comparable to positron emission tomography (PET) imaging and cerebrospinal fluid (CSF) testing obtained through lumbar puncture. Labcorp's test meets performance criteria to confirm the presence of amyloid pathology consistent with Alzheimer's disease, and, in connection with clinical findings, supports an accelerated path to diagnosis in patients being evaluated for Alzheimer's disease and other causes of cognitive decline.

An estimated 6.9 million Americans are living with Alzheimer's disease, a number expected to nearly double by 2050. The average time between onset of symptoms and diagnosis of Alzheimer's disease is approximately 2.8 years. Today, an Alzheimer's diagnosis often involves amyloid PET imaging and invasive CSF testing, which can be costly, time-consuming and uncomfortable.

"For too many patients and their families, the journey from symptoms to diagnosis of Alzheimer's disease can be long, difficult and uncertain," said Dr. Brian Caveney, Labcorp's chief medical and scientific officer. "Our pTau-217/Beta Amyloid 42 Ratio is a significant breakthrough, improving the diagnostic process for a complex disease. This test has the potential to reduce the time and anxiety associated with identifying Alzheimer's disease, enabling patients and their families to make more timely and informed treatment decisions."

Key Features of Labcorp's pTau-217/Beta Amyloid 42 Ratioi

  • A first-of-its-kind immunoassay measuring two distinct biomarkers known as indicators of Alzheimer's disease: pTau-217 and Beta Amyloid 42, in ratio.
  • Offers a sensitivity and specificity of 95%, which is substantially equivalent to the performance of amyloid PET imaging and CSF testing.
  • Patient blood draws can be completed in a physician's office or any of Labcorp's more than 2,000 Patient Service Centers (PSCs) nationwide.
  • Available for use in clinical trials in addition to clinical patient care.

Labcorp will present data related to the pTau-217/Beta Amyloid 42 Ratio at the American Association of Neurology's 2025 Annual Meeting April 5 – 9 in San Diego.

For more information, visit Labcorp's Alzheimer's disease testing portfolio.

About Labcorp
Labcorp (NYSE: LH) is a global leader of innovative and comprehensive laboratory services that helps doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. We provide insights and advance science to improve health and improve lives through our unparalleled diagnostics and drug development laboratory capabilities. The company's nearly 70,000 employees serve clients in approximately 100 countries, provided support for more than 75% of the new drugs and therapeutic products approved in 2024 by the FDA, and perform more than 700 million tests annually for patients around the world. Learn more about us at www.labcorp.com.

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i This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration. This test is not intended as a screening test for Alzheimer's disease in asymptomatic individuals.

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SOURCE Labcorp

Media, Alissa Lawver, Media@Labcorp.com; Investors, Nickolo Russo, Investor@Labcorp.com