Abbott Blood Test To Evaluate Mild Concussions Wins FDA Clearance (ArcaMax)

Abbott Blood Test To Evaluate Mild Concussions Wins FDA Clearance

Doctors soon will have a new way to evaluate patients with concussions: a rapid blood test made by Abbott Laboratories that has been cleared by the U.S. Food and Drug Administration. It’s an advancement that could eliminate the need for some patients to get costly CT scans and the radiation exposure that accompanies them.

The FDA approved a similar blood test in 2018, but that test, made by UF startup and UF Innovate | Sid Martin Biotech graduate Banyan Biomarkers, was never made widely available to hospitals and doctors. Banyan licensed the University of Florida technology to Abbott, which was able to use the prior FDA approval by Banyan as a predicate for their traumatic brain injury test.

The test works by measuring proteins that can be present in the blood after a traumatic brain injury. It uses blood drawn from the arm and can be performed on a handheld device. It can produce results in 15 minutes after the plasma is extracted from the blood, which typically takes place in a lab. The test has been approved for use in people ages 18 years and older.

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