Accelerating Alzheimer's diagnosis with a new blood test, introduced by Labcorp.
In a groundbreaking development, Labcorp, a leading diagnostic company, has launched a new blood-based biomarker test to support the diagnosis of Alzheimer's disease in the United States. This test, if approved, could revolutionise the timely diagnosis of Alzheimer's, reducing the reliance on imaging and cerebrospinal fluid assays.
The test measures the ratio of ptau-217 and beta amyloid 42, two distinct biomarkers of Alzheimer's. Labcorp claims that the performance of the ptau-217/beta amyloid 42 ratio test is substantially equivalent to CSF assays and PET imaging cleared by the Food and Drug Administration.
Patients can provide blood samples at their physician's office or any of Labcorp's more than 2,000 patient service centers in the U.S. The sensitivity and specificity of the test are both 95%, according to Labcorp.
The competitive landscape for blood-based biomarker tests for Alzheimer's disease is intensifying, with several diagnostic companies submitting IVD applications. Among the key players, Roche Diagnostics stands out with its Elecsys® pTau217 assay, which has gained significant attention as a reliable blood biomarker test for Alzheimer's.
Roche's pTau217 assay provides results comparable to PET scans and cerebrospinal fluid (CSF) biomarkers. The test has received Breakthrough Device Designation by the FDA and is being used in Roche's TRONTIER clinical studies. Roche emphasises that this test can transform Alzheimer's diagnosis by enabling simple blood draw-based testing with routine lab analysis, facilitating earlier and more accessible diagnosis globally.
Fujirebio Diagnostics also made headlines when its Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test received FDA approval in May 2025, making it the first blood biomarker test approved to assist in Alzheimer's diagnosis.
ALZpath, Quest Diagnostics, Amprion, Labcorp, and Quanterix also offer blood biomarker tests with high sensitivity (≥90%) targeting amyloid and tau pathology, broadening the options in this competitive space.
The Global CEO Initiative on Alzheimer's Disease has called ptau-217 one of the most promising blood-based biomarkers for amyloid status. The average time between the onset of symptoms and the diagnosis of Alzheimer's is approximately 2.8 years, according to a paper published in 2002. Early and accurate diagnosis is crucial for effective treatment and management of the disease.
The current competitive dynamics may evolve further with ongoing collaborative research such as the FNIH Biomarkers Consortium's AD Biosignature Project, focusing on developing panels of blood-based tests to predict Alzheimer's risk and cognitive decline earlier in the disease course.
In conclusion, the launch of Labcorp's blood test for neurodegenerative disease biomarker marks a significant shift towards more accessible, less invasive Alzheimer's diagnosis in diverse healthcare settings. The competition for blood-based ptau-217 tests among Alzheimer's diagnostics is robust, with Roche and Fujirebio leading with FDA Breakthrough Device and approval status respectively. These developments offer hope for earlier and more accurate diagnosis of Alzheimer's, improving the lives of millions of patients worldwide.
[1] Labcorp Press Release. (2022, July 14). Labcorp Launches Blood-Based Biomarker Test in the U.S. to Support the Diagnosis of Alzheimer's Disease. Retrieved from https://www.labcorp.com/news/articles/labcorp-launches-blood-based-biomarker-test-in-the-us-to-support-the-diagnosis-of-alzheimer-s-disease
[2] Alzheimer's Association. (2022). Blood-Based Biomarkers for Alzheimer's Disease. Retrieved from https://www.alz.org/alzheimers-dementia/research_progress/blood-based-biomarkers
[3] FNIH Biomarkers Consortium. (n.d.). AD Biosignature Project. Retrieved from https://www.fnih.org/programs/ad-biosignature-project
[4] Fujirebio Diagnostics Press Release. (2025, May). Fujirebio Diagnostics Receives FDA Approval for Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio Test. Retrieved from https://www.fujirebio-diagnostics.com/en/news/2025/05/press-release-fujirebio-diagnostics-receives-fda-approval-for-lumipulse-g-ptau217beta-amyloid-1-42-plasma-ratio-test/
- The diagnostic landscape for Alzheimer's disease is undergoing a transformation with the launch of Labcorp's new blood-based biomarker test, offering more accessible and less invasive diagnostic options.
- The competitive environment for blood-based biomarker tests for Alzheimer's disease is intensifying, with several diagnostic companies vying for approval, including Roche Diagnostics, Fujirebio Diagnostics, and ALZpath.
- Roche Diagnostics' Elecsys® pTau217 assay and Fujirebio Diagnostics' Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test have received significant attention as reliable blood biomarker tests for Alzheimer's detection.
- Scientific organizations, such as the Global CEO Initiative on Alzheimer's Disease, consider ptau-217 to be a promising blood-based biomarker for amyloid status.
- The diagnostic breakthroughs in medtech, including blood-based biomarker tests for Alzheimer's disease, have significant implications for the early and accurate diagnosis of medical-conditions like Alzheimer's, neurological disorders, and other health-and-wellness concerns.
- These advances could potentially revolutionize the treatment and management of diseases like Alzheimer's by enabling earlier intervention,leading to better patient outcomes.
- News outlets and patient advocacy groups eagerly report on these developments in AI, science, and medical-conditions like Alzheimer's disease, keeping the public informed about the latest therapies-and-treatments.
- As companies like Labcorp, Roche Diagnostics, and Fujirebio Diagnostics continue to innovate in Alzheimer's diagnostics, there is hope for the development of more accurate and accessible tests, ultimately benefiting millions of patients worldwide.
