Labcorp Launches First-of-its-Kind Immunoassay to Accelerate Path to Diagnosis of Alzheimer's Disease
Rhea-AI Summary
Labcorp (NYSE: LH) has launched a groundbreaking blood-based biomarker test nationwide to aid in Alzheimer's disease diagnosis. The pTau-217/Beta Amyloid 42 Ratio test offers results comparable to PET imaging and CSF testing, with 95% sensitivity and specificity.
This innovative immunoassay measures two distinct biomarkers: pTau-217 and Beta Amyloid 42 in ratio, meeting performance criteria to confirm amyloid pathology consistent with Alzheimer's. The test is available at physician offices and Labcorp's 2,000+ Patient Service Centers nationwide, offering a less invasive alternative to current diagnostic methods.
With 6.9 million Americans living with Alzheimer's and diagnosis typically taking 2.8 years from symptom onset, this breakthrough aims to accelerate the diagnostic process. The test is available for both clinical trials and patient care, with data presentation scheduled at the American Association of Neurology's 2025 Annual Meeting in San Diego.
Positive
- First-of-its-kind blood test with 95% accuracy for Alzheimer's diagnosis
- Nationwide availability through 2,000+ Patient Service Centers
- Less invasive and potentially more cost-effective than current diagnostic methods
- Dual application for clinical trials and patient care
Negative
- None.
News Market Reaction 1 Alert
On the day this news was published, LH gained 1.60%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Labcorp's pTau-217/Beta Amyloid 42 Ratio blood test meets the performance criteria to confirm amyloid pathology consistent with Alzheimer's disease
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
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
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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