Abbott Reaches Concussion Testing Milestone

FDA clearance of Abbott’s traumatic brain injury blood test marks a significant advancement in concussion assessment.

Strategy and Strength|Mar.31, 2023

Abbott's diagnostic portfolio has reached new heights with the recent U.S. Food and Drug Administration (FDA) clearance of the first commercially available laboratory blood test to help evaluate traumatic brain injuries (TBIs), including concussions.

The test, which runs on Abbott’s Alinity i laboratory instrument already in use in a significant number of labs across the United States, measures two biomarkers in the blood that are tightly correlated to brain injury. Reliable results are generated in as few as 18 minutes, and a negative result helps rule out the need for a CT scan.

Concussion evaluation has been substantively unchanged since the Glasgow Coma Scale was introduced in 1974, making Abbott’s blood test a game-changer that could ultimately transform the standard of care due to its speed, accuracy and objectivity.

Leading the Industry

This latest clearance complements Abbott’s i-STAT TBI Plasma test, the first rapid blood test on a portable analyzer to help evaluate mild TBI, which received FDA clearance in 2021. Now, however, TBI blood tests can be run on the high-throughput Alinity i, which will broaden access and allow clinicians to quickly assess individuals with mild TBIs. Having a blood test available could help reduce the number of unnecessary CT scans by up to 40%.

This test puts Abbott at the forefront of diagnostic innovation and reinforces its position as a leader in TBI testing.