Broader reach of blood-based biomarkers for Alzheimer’s can shift dynamics of access

Healio spoke with Labcorp chief medical and scientific officer Brian Caveney, MD, who discussed how his company will meet this need for access, particularly for underrepresented populations in underserved locations.

Healio: Explain briefly how Labcorp’s network was able to broaden the release of the new blood-based biomarker.

Caveney: Labcorp’s national infrastructure enables us to quickly scale access to new, advanced diagnostics.

Following FDA clearance of the Lumipulse pTau-217/beta amyloid 42 ratio, we quickly validated the new test and integrated it across our national network. In addition, our experience with the launch earlier this year of a similar laboratory-developed test (LDT) provided us with valuable experience and insight to help prepare us to make the FDA-cleared test available.

Our infrastructure includes:

• integrated partnerships with major hospitals and health systems and regional/local laboratories;
• high-capacity laboratories strategically located across the country, equipped with advanced technology to process millions of tests efficiently and accurately;
• digital platforms and logistics systems that support specimen tracking, data reporting, and provider connectivity, ensuring timely and secure delivery of results; and,
• mobile and at-home collection services, expanding access for patients who need flexible options.

Patients can now complete a simple blood draw in a physician’s office or in any Labcorp center.

Healio: How does Labcorp plan to address existing gaps among underserved groups or underrepresented populations with this new distribution effort?

Caveney: One of the biggest barriers to AD diagnosis has been access, including access to specialists, advanced imaging or even a clear path forward. Blood-based tests like this have the potential to shift that dynamic.

By offering the test through a standard blood draw and through specimen collection at the point of care, Labcorp is helping to remove some of the cost, travel and logistical barriers that disproportionately affect so many patients and their families.

Healio: What would the company’s recommendations be to clinicians who deal with Alzheimer’s disease, in light of the biomarker’s wider availability?

Caveney: We recommend clinicians consider this FDA-cleared test as part of their broader evaluation toolkit for patients aged 50 and older presenting with signs or symptoms of cognitive decline.

The test is intended to support the diagnostic process, not replace clinical judgment, and may be especially helpful in specialty care settings where early insight into amyloid pathology can guide next steps.

Brian Caveney

Used in the right setting, it can help speed up the traditionally lengthy diagnostic process and bring clarity to an often difficult journey for patients and their families.

Healio: In what ways does this new pTau-217/amyloid-beta 42 ratio biomarker improve upon or differentiate itself from the one launched in April?

Caveney: The test Labcorp launched in April was an LDT, validated and performed under Clinical Laboratory Improvement Amendments (CLIA) regulations. It used the same biomarker combination, pTau-217 and beta amyloid 42 in plasma, in the same ratio and on the same platform as the Lumipulse pTau-217/beta amyloid 42 ratio.

However, the newly launched Lumipulse pTau-217/beta amyloid 42 ratio is an FDA-cleared assay developed by Fujirebio. Unlike an LDT, this test offers the added value of being reviewed and authorized by the FDA, supporting broader clinical confidence and national standardization.

Physicians can also use Labcorp Test Finder, a first-of-its-kind generative AI tool used to simplify lab test search. By asking questions or describing conditions in plain language, physicians can receive a detailed list of suggested tests and descriptions based on their input. Healio: With recent research focusing on detection at earlier stages of life, do you anticipate rolling back the age limit for its utilization? Would future approvals of blood-based biomarkers allow for use at an earlier age?

Caveney: The age range is based on the clinical study population submitted for FDA review, and that’s standard practice. As research continues and additional data are generated, future iterations or new biomarkers may expand to younger populations. Labcorp is closely following developments in this space and will continue evolving its offerings to reflect the latest science and regulatory guidance.

Healio: Does Labcorp anticipate engaging in future agreements for the distribution of additional FDA-approved blood-based biomarkers?

Caveney: As more blood-based biomarkers are developed, cleared and validated, we want to be the lab that makes those tools available to clinicians and patients, whether they are developed internally, in collaboration with partners, or through FDA-approved products.

Labcorp is committed to expanding access to these innovative diagnostics and will continue to evaluate new technologies and partnerships that support earlier, more accurate and more equitable care for patients. We are always exploring new opportunities to advance diagnostics, but we don’t comment on potential launches or partnerships until they are publicly announced.

Reference:

Labcorp launches first FDA-cleared blood test for Alzheimer’s disease. https://www.labcorp.com/education-events/press-releases/labcorp-launches-first-fda-cleared-blood-test-alzheimers-disease. Published Aug. 18, 2025, Accessed Aug, 20, 2025.

For more information:

Brian Caveney, MD, can be reached at neurology@healio.com.