Global Alzheimer’s Platform Foundation Applauds FDA Authorization of the First Blood-Based Diagnostic Test for Assessing Alzheimer’s Disease

/EIN News/ -- WASHINGTON, May 20, 2025 (GLOBE NEWSWIRE) -- The Global Alzheimer’s Platform Foundation® (GAP) applauds the FDA's clearance of the first blood test to diagnose Alzheimer’s disease. Fujirebio’s Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio invitro diagnostic (IVD) represents the first blood-based test available to physicians and their patients for early detection of amyloid plaques associated with Alzheimer’s—a critical element in accurately diagnosing Alzheimer’s disease (AD). This new test presents a faster, less invasive and much more accessible method for diagnosis, in contrast with tests based on a PET scan or collection of cerebral spinal fluid (CSF).

GAP is proud that its AD biomarker study, Bio-Hermes-001, played a principal role in the dataset used to support Fujirebio’s FDA application for clearance of the first groundbreaking blood based IVD available for the diagnosis of Alzheimer’s Disease (AD). Bio-Hermes-001 was designed to provide head-to-head comparisons of data available on leading Alzheimer’s blood tests and PET tests from 1,000 highly characterized and representative study volunteers demonstrating signs and symptoms associated with Alzheimer's disease.

John Dwyer, President of the Global Alzheimer’s Platform Foundation stated, “We commend the FDA’s clearance of Fujirebio’s Lumipulse submission, as this IVD is poised to fundamentally change the Alzheimer’s diagnostic process and significantly improve the ability of physicians to accurately access and treat AD and empower people to take action to address their condition. GAP is extremely proud that its Bio-Hermes-001 biomarker study materially contributed to this landmark IVD. We intentionally designed that unique study to drive forward new technologies and treatment processes for Alzheimer’s and related dementias. We want to thank the thousand volunteers who participated in Bio-Hermes 1; the numerous clinical trial sites that tirelessly worked with us on the study as well as the dozens of technology, pharmaceutical, and philanthropy partners that collaborated with us to support Bio-Hermes. GAP celebrates this remarkable clearance, which has the potential to transform the future of AD diagnostics and treatments.”

About the Global Alzheimer’s Platform Foundation (GAP)
The nonprofit Global Alzheimer’s Platform Foundation was founded to speed the delivery of Alzheimer’s treatments with a commitment to promoting diversity in clinical research, as well as lowering the cost and improving the efficacy of ADRD clinical trials to ensure that no one is left behind. As part of its mission, GAP supports more than 100 clinical research sites worldwide through study start-up and recruitment activities, promoting diversity in research studies, and giving attention to the citizen scientists who make research possible.

Contact: media@globalalzplatform.org