Labcorp launches FDA-cleared blood test to support initial Alzheimer's disease assessment in primary care
Elecsys pTau-181 test helps clinicians rule out Alzheimer's disease by identifying patients unlikely to have amyloid pathology
5 May 2026Product news
Labcorp, a provider of innovative and comprehensive laboratory services, has announced the availability in the United States of the Elecsys® pTau-181 test, the first and only blood test cleared by the U.S. Food and Drug Administration (FDA) to aid in the initial assessment of Alzheimer’s disease in the primary care setting.
This launch expands Labcorp’s portfolio of Alzheimer’s disease blood tests, providing primary care and specialty care clinicians with new tools to support earlier assessment and diagnosis.
Expanding access to Alzheimer’s disease testing in primary care
Primary care clinicians are often the first point of contact for patients experiencing cognitive symptoms, yet Alzheimer’s disease testing has historically required a visit to a specialist. By offering the Elecsys pTau-181 test nationwide, Labcorp enables primary care clinicians across the U.S. to integrate an FDA-cleared blood test into the initial assessment of patients with suspected Alzheimer’s disease.
The Elecsys pTau-181 test was developed by Roche Diagnostics and received FDA clearance in 2025. Labcorp now offers this test through its extensive national network, including more than 2,200 patient service centers.
How the Elecsys pTau-181 test supports Alzheimer’s assessment
The Elecsys pTau-181 test helps clinicians rule out Alzheimer’s disease by identifying which symptomatic patients aged 55 and older are unlikely to have amyloid pathology, the abnormal protein buildup in the brain associated with Alzheimer’s disease, in the context of all clinical findings.
Patients with negative Elecsys pTau-181 test results can be evaluated for other potential causes of cognitive decline, while patients with positive results can be referred for additional testing. This approach supports more targeted use of specialist referrals and advanced diagnostic procedures.
Key benefits of the Elecsys pTau-181 test
- It offers 97.9% negative predictive value, helping clinicians more confidently rule out Alzheimer’s pathology in symptomatic patients.
- It is performed via a simple blood draw, which can be completed in a doctor’s office or at any of Labcorp’s more than 2,200 patient service centers nationwide.
- It provides an alternative to traditional approaches that require brain scans or lumbar punctures, which can be costly, invasive or difficult to access.
- It helps reduce unnecessary referrals amid a national shortage of neurologists, supporting timely evaluation of other causes of cognitive decline.
Expert perspective on primary care Alzheimer’s testing
“Primary care clinicians are often the first point of contact for patients with concerns related to cognitive symptoms, yet Alzheimer’s testing has historically required a visit to a specialist,” said Dr. Brian Caveney, chief medical and scientific officer at Labcorp. “By making this first-of-its-kind blood test available nationwide, Labcorp is giving primary care clinicians a powerful tool to help patients get answers sooner and guide next steps with confidence.”
Labcorp’s commitment to innovative Alzheimer’s testing
With an estimated 7.2 million Americans living with Alzheimer’s disease, Labcorp is committed to expanding access to blood-based biomarkers that support earlier assessment and diagnosis. The Elecsys pTau-181 test strengthens Labcorp’s portfolio of blood-based biomarker tests for Alzheimer’s disease and other forms of dementia, supporting clinicians across neurology, geriatrics and primary care.
Want the latest science news straight to your inbox? Become a SelectScience member for free today>>
Frequently asked questions
What is the Elecsys® pTau-181 blood test and how does it support the initial assessment of Alzheimer’s disease in primary care?
The Elecsys® pTau-181 test is the first and only blood test cleared by the U.S. Food and Drug Administration (FDA) to aid in the initial assessment of Alzheimer’s disease in the primary care setting. Developed by Roche Diagnostics and made available nationwide in the United States through Labcorp’s network of more than 2,200 patient service centers, this blood-based biomarker test helps primary care and specialty care clinicians assess symptomatic patients aged 55 and older.
By identifying which patients are unlikely to have amyloid pathology — the abnormal protein build up in the brain associated with Alzheimer’s disease — in the context of all clinical findings, the Elecsys pTau-181 test supports earlier assessment, more confident clinical decision-making, and more efficient use of specialist referrals.
How does Labcorp’s nationwide availability of the Elecsys pTau-181 test improve access to Alzheimer’s disease testing for symptomatic patients?
Labcorp’s nationwide launch of the Elecsys pTau-181 test expands access to Alzheimer’s disease testing by bringing an FDA-cleared blood test into the primary care setting, where clinicians are often the first point of contact for patients with cognitive symptoms.
Instead of relying solely on specialist visits, brain scans, or lumbar punctures, which can be costly, invasive, or difficult to access, primary care clinicians across the U.S. can now order a simple blood draw in their offices or at any of Labcorp’s more than 2,200 patient service centers.
This approach helps rule out Alzheimer’s pathology with a 97.9% negative predictive value, reduces unnecessary referrals amid a national shortage of neurologists, and allows patients with negative results to be evaluated promptly for other potential causes of cognitive decline.
What are the key clinical benefits of the FDA-cleared Elecsys pTau-181 test for Alzheimer’s disease offered by Labcorp?
The Elecsys pTau-181 test offers several key clinical benefits for assessing Alzheimer’s disease. It provides a 97.9% negative predictive value, enabling clinicians to more confidently rule out Alzheimer’s-related amyloid pathology in symptomatic patients aged 55 and older.
The test is performed via a simple blood draw, which can be completed in a doctor’s office or at any Labcorp patient service center nationwide, offering a less invasive and more accessible alternative to brain imaging or lumbar punctures.
By distinguishing patients who are unlikely to have amyloid pathology from those who may need further evaluation, the test supports more targeted use of specialist referrals and advanced diagnostic procedures, helping address the national shortage of neurologists and promoting timely evaluation of other causes of cognitive decline.