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First Alzheimer’s Test Hit Market Sans FDA Approval

The new blood test costs about 75% less than current brain scans.

A recent CBS News article noted an important milestone in the fight against Alzheimer’s: the first blood test to diagnose it has hit the market. The test was developed by C2N Diagnostics in St. Louis, and the founders are doctors from Washington University School of Medicine. It costs $1,250 and produces results in about 10 days, but the company offers discounts based on income. While the test aims to provide patients with easier diagnoses, the facts that key test results have yet to be published, and the test isn’t FDA approved raise accuracy concerns.

Alzheimer’s is characterized by memory loss and the buildup of a specific protein in the brain called beta-amyloid. Current tests involve $5,000 brain scans to search for evidence of the protein, which typically aren’t covered by insurance. A spokesperson at the Alzheimer’s Association said that it won’t endorse the test until it receives FDA approval.

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