Blood Biomarkers for Alzheimer’s: Expanding Access & Impact
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Labcorp launches FDA-Cleared Blood Test for Alzheimer’s Disease - Q&A with Brian Caveney,MD
What does the newly launched Lumipulse pTau-217/beta amyloid 42 ratio test do to improve upon or differentiate itself from the one launched in April?
Caveney: The test Labcorp launched in April was a Laboratory developed Test (LDT),validated and performed under Clinical Laboratory Enhancement Amendments (CLIA) regulations. It utilized 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 having undergone FDA review and authorization, fostering broader clinical confidence and national standardization.
Physicians can also utilize Labcorp test finder, a first-of-its-kind generative AI tool designed to simplify lab test searches. By asking questions or describing conditions in plain language, physicians can receive a detailed list of suggested tests and descriptions based on their input.
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 current age range is based on the clinical study population submitted for FDA review, which is standard practice. As research progresses and additional data become available, future iterations or new biomarkers may expand to younger populations. Labcorp is closely monitoring developments in this space and will continue to evolve its offerings to reflect the latest science and regulatory guidance.
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,Labcorp aims to be the laboratory that makes these 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 do not 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[contactInformation-[contactInformation-[contactInformation-[contactInformation-This was missing from the original text]
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Added Placeholder: Noted that contact information for Dr.Caveney was missing.This revised version is more suitable for publication or distribution as a formal Q&A document. Let me know if you’d like any further refinements!