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BioMérieux: head injury test cleared by FDA

( - bioMérieux announces that it has received 510(k) clearance from the US FDA to market Vidas TBI (GFAP, UCH-L1), a serum test for the evaluation and management of patients with mild traumatic brain injury, including concussions.

Based on a unique combination of GFAP and UCH-L1 biomarkers, this test can help limit the number of brain scans for patients with mild traumatic brain injury, by predicting the absence of post-traumatic intracranial injury.

The commercial launch of this test is scheduled for the second half of 2024 in the United States. Also CE marked, it is marketed in certain countries in Europe, North Africa and South America.

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