Labcorp Holdings Inc. has made its Elecsys® pTau‑181 blood test available across the United States, marking the first FDA‑cleared assay designed for initial Alzheimer’s disease assessment in primary care settings.
The test, developed by Roche Diagnostics in partnership with Eli Lilly, received FDA clearance on October 13, 2025. It delivers a 97.9% negative predictive value and enables clinicians to rule out amyloid pathology in symptomatic patients aged 55 and older, providing a non‑invasive alternative to PET scans and lumbar punctures.
Labcorp’s Alzheimer’s biomarker portfolio now includes the Lumipulse® pTau‑217/Beta‑Amyloid 42 Ratio test, launched in April 2025 and made nationwide in August 2025. The addition of the Elecsys® pTau‑181 expands the company’s high‑complexity diagnostics offering and supports its strategy to capture early‑stage Alzheimer’s care pathways.
The launch is expected to broaden Labcorp’s specialty testing mix and drive higher‑margin revenue. In Q1 2025, the Diagnostics Laboratories segment grew 6% in revenue, with total revenue of $3.345 billion versus $3.177 billion a year earlier and net income of $212.8 million versus $228 million a year earlier, underscoring the company’s momentum in this high‑growth area.
Dr. Brian Caveney, Labcorp’s chief medical and scientific officer, said, “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. 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 Alzheimer’s blood‑test market is projected to grow at a CAGR of about 15% from 2025 to 2035, and the FDA clearance legitimizes widespread adoption. Roche’s President and CEO of Diagnostics North America, Brad Moore, added, “By bringing Alzheimer’s blood‑based biomarker testing into primary care, we can help patients and their clinicians get answers sooner to support them earlier in their journeys. This milestone reflects Roche’s leadership in diagnostics and our commitment to expanding access to innovative testing for patients and their clinicians.”
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