Labcorp将上线Roche获FDA许可的阿尔茨海默病pTau-217血检

- Elecsys® pTau-217 is the first and only FDA-cleared single-biomarker blood test to both rule in and rule out amyloid pathology across specialty and primary care settings
- Measures phosphorylated Tau 217 (pTau-217), an indicator of amyloid pathology and a hallmark of Alzheimer's disease
- Intended for individuals 55 and older with signs, symptoms or complaints of cognitive decline
BURLINGTON, N.C., Aug. 24, 2026 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today it will offer the Elecsys® pTau-217 test following clearance by the U.S. Food and Drug Administration (FDA). Developed by Roche Diagnostics, the blood test aids in identifying amyloid pathology associated with Alzheimer's disease in individuals 55 and older with signs, symptoms or complaints of cognitive decline. Elecsys® pTau-217 is the first and only FDA-cleared single-biomarker blood test to both rule in and rule out amyloid pathology across specialty and primary care settings
For many individuals experiencing cognitive decline, evaluation for Alzheimer's disease often involves multiple tests, care settings and healthcare providers. As blood-based biomarkers for neurological conditions continue to advance, pTau-217 has emerged as a leading biomarker to help clinicians rule in or rule out amyloid pathology in people presenting with symptoms or concerns of cognitive decline. While several pTau-217 assays are commercially available, standardization across care settings remains an important consideration for clinicians. The Elecsys® pTau-217 test provides a single, standardized assay with the same clinically validated cutoffs across primary and specialty care settings, supporting a consistent approach to patient assessment.
"The best advances in Alzheimer's disease testing should make the diagnostic process simpler, more accessible and more consistent for both patients and clinicians," said Dr. Brian Caveney, chief medical and scientific officer at Labcorp. "For individuals and families seeking answers about cognitive changes, the path to evaluation can be long and uncertain. By making the Elecsys® pTau-217 test available nationwide, Labcorp is expanding access to innovative blood-based testing and helping clinicians provide more timely assessments and informed next steps for patients."
Key Features of the Elecsys® pTau-217 Test
- Uses the same clinical cutoffs across primary and specialty care settings, providing a standardized approach to patient assessment.
- Provides positive, intermediate and negative result categories to support assessment of the likelihood of amyloid pathology.
- Offers a convenient, minimally invasive blood-based testing option with performance comparable to cerebrospinal fluid (CSF) testing and positron emission tomography (PET) imaging.
- Once ordered by a clinician, patients can have their blood drawn in a physician's office or at one of Labcorp's more than 2,200 patient service centers nationwide.
- Results are interpreted alongside clinical information and other relevant findings as part of a comprehensive evaluation.
Advancing Labcorp's Alzheimer's Disease Testing Portfolio
The addition of Elecsys® pTau-217 expands Labcorp's Alzheimer's disease testing portfolio. The test joins Labcorp's existing offerings, including the FDA-cleared Elecsys® pTau-181 test and the Lumipulse® pTau-217/Beta-Amyloid 42 Ratio.
Labcorp plans to make the test available nationwide in the coming months. For more information about Labcorp's Alzheimer's disease testing, 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 71,000 employees serve clients in approximately 100 countries, provided support for more than 85% of the new drugs and therapeutic products approved by the FDA in 2025 and performed more than 750 million tests for patients around the world. Learn more at www.labcorp.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements with respect to the expected availability, utility, and benefits of the Elecsys® pTau217 test to detect Alzheimer's disease pathology.
Each of the forward-looking statements is subject to change based on various important factors, many of which are beyond the company's control. These factors, in some cases, have affected and in the future (together with other factors) could affect the company's ability to implement the company's business strategy, and actual results could differ materially from those suggested by these forward-looking statements. As a result, readers are cautioned not to place undue reliance on any of the forward-looking statements.
The company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Further information on potential factors, risks and uncertainties that could affect operating and financial results is included in the company's most recent Annual Report on Form 10-K under the heading RISK FACTORS and in the company's other filings with the SEC. The information in this press release should be read in conjunction with a review of the company's filings with the SEC including the information in the company's most recent Annual Report on Form 10-K under the heading "MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS."
SOURCE Labcorp