Q&A: Broader reach of blood-based biomarkers for Alzheimer’s can shift dynamics of access

By Admin

09 Sep, 2025

Alzheimer’s disease remains one of the most challenging health conditions worldwide, with diagnosis often delayed due to limited access to specialists, imaging, and advanced diagnostic tools. The arrival of blood-based biomarker testing promises to reshape this landscape by making early detection easier, faster, and more widely available.

Recently, Labcorp launched the Lumipulse pTau-217/beta amyloid 42 ratio test, developed by Fujirebio Diagnostics the first FDA-cleared blood test for Alzheimer’s disease. With a positive predictive value of 92% and a negative predictive value of 97%, the test provides a highly reliable indication of amyloid pathology, a hallmark of Alzheimer’s.

To understand the impact of this launch, Healio spoke with Brian Caveney, MD, chief medical and scientific officer at Labcorp, about how this innovation could transform access to Alzheimer’s diagnostics in the U.S.

Expanding Access Through Labcorp’s National Network

Caveney explained that Labcorp’s national infrastructure enables rapid distribution of new diagnostics. Following FDA clearance, the Lumipulse test was quickly validated and integrated across Labcorp’s network, building on earlier experience with a laboratory-developed test (LDT) launched in April.

Labcorp’s infrastructure includes:

• Partnerships with hospitals, health systems, and local labs
  
  

• High-capacity labs nationwide, equipped with advanced technology
  
  

• Digital platforms for specimen tracking, data reporting, and provider connectivity
  
  

• Mobile and at-home collection services
  
  

This network ensures that patients can access the test through a simple blood draw in a physician’s office or at any Labcorp facility.

Addressing Gaps for Underserved Populations

A major barrier in Alzheimer’s diagnosis has long been limited access to specialists and costly imaging. By shifting diagnostics toward a simple blood test, Labcorp helps remove cost, travel, and logistical hurdles that disproportionately affect underserved communities.

Caveney noted, “Blood-based tests like this have the potential to shift that dynamic. By offering the test through a standard blood draw and collection at the point of care, Labcorp is helping to reduce barriers for many patients and families.”

Guidance for Clinicians

Labcorp recommends that clinicians consider this FDA-cleared test as part of their diagnostic toolkit, particularly for patients aged 50 and older presenting with cognitive decline.

The test supports, but does not replace, clinical judgment. It can provide valuable insight earlier in the diagnostic journey, helping specialists decide on next steps and reducing the traditionally lengthy timeline to diagnosis.

How It Differs from Earlier Tests

The test introduced in April was an LDT, validated under CLIA regulations, using the same biomarker combination (pTau-217 and beta amyloid 42). The key difference is that the new Lumipulse version is FDA-cleared, bringing:

• Greater clinical confidence
  
  

• National standardization of results
  
  

• Wider adoption among physicians
  
  

Additionally, Labcorp has introduced Labcorp Test Finder, a generative AI-powered platform that helps physicians identify and order appropriate tests by simply describing patient conditions in plain language.

Looking Ahead: Future of Blood-Based Biomarkers

While the current test is intended for patients 50 and older, future research may support expanding use to younger populations. Labcorp is actively monitoring new studies and evolving its offerings as science and regulatory guidance advance.

Caveney confirmed that Labcorp intends to play a central role in distributing future FDA-approved blood-based biomarkers, whether developed internally, in partnerships, or through external innovations. The company’s goal remains clear: make advanced diagnostics accessible, equitable, and impactful for patients nationwide.

Key Takeaways

• Labcorp’s nationwide network expands access to FDA-cleared Alzheimer’s blood testing.
  
  

• The Lumipulse pTau-217/beta amyloid 42 ratio test shows strong predictive accuracy (92% PPV, 97% NPV).
  
  

• Blood-based biomarkers support, not replace, clinical judgment.
  
  

• Access improvements can particularly benefit underserved populations.
  
  

• FDA clearance boosts clinical confidence and standardization across the U.S.