FDA OKs first blood test that can help diagnose Alzheimer’s disease

U.S. health authorities have approved the first blood test capable of diagnosing Alzheimer’s disease, providing crucial information for identifying patients who may benefit from medications that can help slow down the progression of the condition. The test can assist physicians in determining whether memory issues in a patient are related to Alzheimer’s or other medical conditions that can affect cognitive function. The FDA has authorized the test for individuals aged 55 and above who are displaying early signs of the disease. Alzheimer’s, the most prevalent form of dementia, affects over 6 million people in the U.S. and millions more worldwide.

Developed by Fujirebio Diagnostics, Inc., the new test can detect beta-amyloid, a sticky brain plaque that serves as a critical indicator of Alzheimer’s. Previously, invasive spinal fluid tests or costly PET scans were the only FDA-approved methods for detecting amyloid. The introduction of a more affordable and convenient blood test could lead to wider use of two recently developed drugs, Leqembi and Kisunla, which have been shown to slow down the progression of Alzheimer’s by removing amyloid from the brain.

Dr. Michelle Tarver from the FDA’s center for devices noted that the approval of this test marks a significant advancement in Alzheimer’s disease diagnosis, potentially making it more accessible to patients in the U.S. at an earlier stage of the disease. While numerous hospitals and labs have created their own tests for amyloid, these tests lack FDA review and insurance coverage. Additionally, larger companies like Roche, Eli Lilly, and C2N Diagnostics are working on developing their own tests for FDA approval.

It is important to emphasize that these tests are only to be ordered by a physician and are not meant for individuals without any symptoms of the disease.