Blood tests for diagnosing Alzheimer's disease are eagerly awaited, but it may be a couple of years before they become a routine diagnostic tool.
While several blood tests for Alzheimer's diagnosis are in development, none are approved by regulators or insurance reimbursement.
Some are currently used to screen participants enrolling in Alzheimer's trials.
There is an ongoing debate about which blood biomarkers accurately signal the presence of amyloid and tau in the brain.
Currently, patients who could benefit from Eisai Co Ltd's ESALY / Biogen Inc's BIIB new Alzheimer's drug, Leqembi, rely on cognitive assessments or invasive cerebrospinal fluid tests, often inaccessible in some regions.
Citing Dr. Sarah Kremen, director of the neurobehavior program at Cedars-Sinai Medical Center, Reuters noted warnings associated with amyloid alone is an unreliable marker for Alzheimer's since it accumulates in aging brains without causing dementia.
Laboratory Corporation Of America Holdings LH and Quest Diagnostics Incorporated DGX have introduced blood tests measuring amyloid, tau, and neurodegeneration, but concerns about accuracy and overuse led neurology centers to caution against consumer tests for those without risk factors or symptoms.
Eli Lilly And Co LLY is working with Quanterix on an experimental tau biomarker blood test. It has also partnered with Roche Holdings AG RHHBY to develop a test measuring blood levels of a different tau protein and a gene associated with Alzheimer's risk.
Citing Roche Diagnostics' executive, Reuters reported that the company expects to have results from a large trial and file for the U.S. approval of its Elecsys Amyloid Plasma Panel in 2025.
Accurate blood tests are anticipated to help distinguish Alzheimer's from other causes of dementia. The Alzheimer's Association estimates that 6.7 million Americans have the disease, but biological testing could reduce this by up to 30%.
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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