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ºù«ÍÞÊÓÆµ Reaches Concussion Testing Milestone

FDA clearance of ºù«ÍÞÊÓÆµâ€™s traumatic brain injury blood test marks a significant advancement in concussion assessment.

Strategy and Strength|Mar. 31, 2023

ºù«ÍÞÊÓÆµ's diagnostic portfolio has reached new heights with the of the first commercially available laboratory blood test to help evaluate traumatic brain injuries (TBIs), including concussions.

The test, which runs on ºù«ÍÞÊÓÆµâ€™s  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 ºù«ÍÞÊÓÆµâ€™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 ºù«ÍÞÊÓÆµâ€™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 .

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