Labcorp Launches First FDA-Cleared Blood Test for Alzheimer's Disease
Rhea-AI Summary
Labcorp (NYSE:LH) has launched the Lumipulse® pTau-217/Beta Amyloid 42 Ratio, the first FDA-cleared blood test for Alzheimer's disease diagnosis. This groundbreaking test demonstrates 92% positive predictive value and 97% negative predictive value in clinical studies.
The blood-based diagnostic test provides comparable results to traditional methods like CSF testing and PET scans, but through a simpler, more affordable, and less invasive blood draw. Available nationwide through Labcorp's 2,200+ Patient Service Centers, the test is designed for adults 50 and older showing cognitive decline symptoms in specialized care settings.
Positive
- First FDA-cleared blood test for Alzheimer's disease diagnosis
- High accuracy with 92% positive and 97% negative predictive values
- More affordable and accessible alternative to traditional diagnostic methods
- Nationwide availability through 2,200+ Patient Service Centers
Negative
- Test cannot be used as a standalone diagnostic tool
- Limited to specialized care settings only
- Restricted to patients 50 years and older with existing cognitive decline symptoms
News Market Reaction
On the day this news was published, LH gained 0.04%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Lumipulse® pTau-217/Beta Amyloid 42 Ratio now available nationwide through Labcorp
The test offers results that are comparable to existing methods that support a diagnosis of Alzheimer's disease – cerebrospinal fluid (CSF) testing obtained through lumbar puncture and positron emission tomography (PET) scans – but from a simple blood draw, making it more affordable, more accessible and less invasive. Fujirebio reports that in clinical studies, the test demonstrated a positive predictive value of
"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. "Clinicians need better ways to diagnose their patients more quickly, enroll them in clinical trials, or start therapies. By offering this FDA-cleared blood test nationwide, Labcorp is leading the way in delivering innovative solutions for Alzheimer's disease and other neurological conditions by helping patients, families and physicians get answers sooner."
The launch of this test closely follows the release of a new clinical guideline from the Alzheimer's Association, which supports the use of blood-based biomarkers to help evaluate patients suspected of Alzheimer's disease in specialty care settings. The guideline highlights the growing clinical consensus around these tools and reinforces the importance of expanding access.
The Lumipulse pTau-217/Beta Amyloid 42 Ratio is intended for adults aged 50 years and older presenting at a specialized care setting with signs and symptoms of cognitive decline. It is not intended as a screening or stand-alone diagnostic test and must be interpreted in conjunction with other clinical information of the patient. Once ordered, patients can complete the blood draw in a healthcare provider's office or any of Labcorp's more than 2,200 Patient Service Centers (PSCs) nationwide.
The FDA-cleared test builds on and replaces a similar pTau-217/Beta Amyloid 42 Ratio test that the company launched in April 2025.
For more information about Labcorp's portfolio of blood-based biomarkers for Alzheimer's disease and dementia, visit https://www.labcorp.com/treatment-areas/neurology/conditions/neurodegenerative/alzheimers
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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SOURCE Labcorp
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