Labcorp Launches First FDA-Cleared Blood Test for Alzheimer's Disease Assessment in Primary Care

Rhea-AI Summary

Labcorp (NYSE: LH) announced nationwide availability of the Elecsys® pTau-181 blood test cleared by the FDA to aid initial assessment of Alzheimer’s disease in primary care for symptomatic patients aged 55 and older. The test offers a 97.9% negative predictive value, is performed by simple blood draw at Labcorp's >2,200 patient service centers, and aims to reduce reliance on brain scans or lumbar punctures. Developed by Roche Diagnostics and FDA-cleared in 2025, the test complements Labcorp's biomarker portfolio and supports diagnostic and therapeutic workflows, including contributions to >90 Alzheimer's protocols across 45 countries.

Positive

• Offers 97.9% negative predictive value to help rule out Alzheimer’s pathology
• Available nationwide in primary care and at >2,200 patient service centers
• Simple blood draw alternative to costly or invasive scans and lumbar punctures
• Supports therapeutic development: contributed to >90 Alzheimer's protocols in 45 countries

Negative

• Indicated only for symptomatic patients aged 55 and older, limiting broader screening use
• Positive results require referral for additional testing; not diagnostic on its own

Key Figures

Negative predictive value: 97.9% Patient age threshold: 55+ years Service centers: More than 2,200 +3 more

6 metrics

Negative predictive value 97.9% Elecsys pTau-181 test performance for ruling out Alzheimer’s pathology

Patient age threshold 55+ years Intended for symptomatic primary care patients

Service centers More than 2,200 Labcorp patient service centers where the blood draw can be performed

Americans with Alzheimer’s 7.2 million Estimated U.S. population living with Alzheimer’s disease

Alzheimer’s protocols More than 90 Therapeutic development protocols supported over last five years

Countries in protocols More than 45 Countries involved in Alzheimer’s protocols over last five years

Market Reality Check

Price: $289.89 Vol: Volume 1,017,386 is 1.23x...

normal vol

$289.89 Last Close

Volume Volume 1,017,386 is 1.23x the 20-day average of 830,096, indicating elevated interest ahead of and around this launch. normal

Technical Price $284.50 is trading above the 200-day MA at $263.07, reflecting a pre-existing upward trend.

Peers on Argus

LH gained 3.83% while key peers were mixed: DGX up 5.46%, NTRA up 0.71%, MTD up ...

LH gained 3.83% while key peers were mixed: DGX up 5.46%, NTRA up 0.71%, MTD up 0.9%, WAT down 0.24%, IQV down 5.45%. The mixed directions and lack of momentum flags suggest a stock-specific reaction to Labcorp’s Alzheimer’s test news rather than a broad sector move.

Historical Context

5 past events · Latest: Feb 09 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 09	Board appointment	Positive	-1.1%	New director with medical leadership background joined Labcorp’s board.
Jan 14	Dividend declaration	Positive	+3.2%	Company announced a quarterly cash dividend of $0.72 per share.
Jan 13	Oncology test expansion	Positive	+1.4%	Expanded MRD testing portfolio for breast, lung and colon cancer risk.
Jan 08	Partnership/product access	Positive	+0.4%	Broadened access to at-home FDA-authorized STI PCR test via Labcorp.
Jan 08	Asset divestiture	Neutral	+0.4%	Sale of early development device testing assets to NAMSA completed.

Pattern Detected

Recent news tied to strategic expansion, dividends and partnerships more often coincided with positive price reactions, with only one notable divergence on a board appointment.

Recent Company History

Over the last few months, Labcorp has focused on strategic portfolio moves and shareholder returns. A board appointment on Feb 9, 2026 saw a modest -1.15% reaction, while a $0.72 quarterly dividend declared on Jan 14, 2026 aligned with a 3.16% gain. Expansion of MRD cancer testing on Jan 13, 2026 and broader access to an at-home STI PCR test on Jan 8, 2026 both coincided with positive moves. The asset sale of an early development device testing business also saw a mild uptick, suggesting the market has generally welcomed Labcorp’s portfolio optimization and diagnostic innovations.

Market Pulse Summary

This announcement introduced the first FDA-cleared blood test to aid Alzheimer’s assessment in prima...

Analysis

This announcement introduced the first FDA-cleared blood test to aid Alzheimer’s assessment in primary care, offering a 97.9% negative predictive value for ruling out amyloid pathology in symptomatic patients aged 55+. With access via more than 2,200 service centers and experience across over 90 Alzheimer’s protocols in 45 countries, Labcorp extended its neurology-focused diagnostics strategy. Investors may watch uptake in primary care, integration with specialist pathways, and future updates on performance and reimbursement.

Key Terms

pTau-181, U.S. Food and Drug Administration, biomarkers

3 terms

pTau-181 medical

"nationwide availability of the Elecsys® pTau-181 test, the first and only blood test"

ptau-181 is a specific form of the brain protein tau that carries a chemical tag at one precise spot (position 181); it can be measured in cerebrospinal fluid or blood and rises when Alzheimer’s-type brain damage is present. Think of it as a smoke alarm for a particular kind of brain injury: higher readings raise concern about disease activity, help doctors and researchers track progression, and are often used to judge whether treatments are working—information that can materially affect biotech valuations and investment decisions.

U.S. Food and Drug Administration regulatory

"only blood test cleared by the U.S. Food and Drug Administration (FDA) to aid"

The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

biomarkers medical

"expanding access to blood-based biomarkers that support earlier assessment and diagnosis"

Biomarkers are measurable indicators found in the body, such as substances in blood or tissues, that reveal information about health or disease. For investors, they can signal how well a medical treatment is working or whether a disease is developing, helping to assess the potential success or risks of healthcare companies or innovations. Think of biomarkers as biological signals that provide clues about a person’s health status.

AI-generated analysis. Not financial advice.

• Elecsys® pTau-181 test helps clinicians rule out Alzheimer's disease by identifying patients unlikely to have amyloid pathology
• Now available nationwide in primary care settings for patients aged 55 and older experiencing symptoms of cognitive decline
• Expands Labcorp's comprehensive portfolio of Alzheimer's disease blood tests across both primary and specialty care settings

BURLINGTON, N.C., Feb. 11, 2026 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the nationwide availability 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 further expands Labcorp's comprehensive portfolio of Alzheimer's disease blood tests, offering clinicians solutions across both primary and specialty care settings.

"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."

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—abnormal protein buildup in the brain associated with Alzheimer's disease—in the context of all clinical findings. Patients with negative results can be evaluated for other potential causes of cognitive decline, while patients with positive results can be referred for additional testing. The test was developed by Roche Diagnostics and cleared by the FDA in 2025.

Key Benefits of the Elecsys pTau-181 Test:

• Offers 97.9% negative predictive value, helping clinicians more confidently rule out Alzheimer's pathology in symptomatic patients
• 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
• Provides an alternative to traditional approaches that require brain scans or lumbar punctures, which can be costly, invasive or difficult to access
• Helps reduce unnecessary referrals amid a national shortage of neurologists, supporting timely evaluation of other causes of cognitive decline

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. To learn more, visit: https://www.labcorp.com/treatment-areas/neurology‑based biomarker tests for Alzheimer's disease and

Labcorp's deep expertise in Alzheimer's biomarkers extends into therapeutic development, supporting more than 90 Alzheimer's disease protocols across more than 45 countries over the last five years. To learn more, visit: https://www.labcorp.com/treatment-areas/neurology/biomarker-development

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.

View original content to download multimedia:https://www.prnewswire.com/news-releases/labcorp-launches-first-fda-cleared-blood-test-for-alzheimers-disease-assessment-in-primary-care-302684545.html

SOURCE Labcorp

FAQ

What does Labcorp's (LH) Elecsys pTau-181 test do for primary care clinicians?

It helps primary care clinicians identify symptomatic patients aged 55+ who are unlikely to have amyloid pathology. According to Labcorp, the test is intended to rule out Alzheimer’s pathology as part of overall clinical evaluation and guide next steps.

How accurate is the Elecsys pTau-181 test that Labcorp (LH) now offers nationwide?

The test has a 97.9% negative predictive value for ruling out amyloid pathology in symptomatic patients. According to Labcorp, this high NPV supports clinician confidence in excluding Alzheimer’s-related amyloid buildup.

Where can patients get the Elecsys pTau-181 blood test from Labcorp (LH)?

Patients can receive the test via a simple blood draw in a doctor's office or at any Labcorp patient service center nationwide. According to Labcorp, the test is available at more than 2,200 patient service centers.

Does a positive Elecsys pTau-181 result from Labcorp (LH) confirm Alzheimer’s disease?

No, a positive result does not confirm Alzheimer’s disease and typically prompts further testing and specialist referral. According to Labcorp, positive findings warrant additional diagnostic evaluation within the broader clinical context.