BioMérieux TBI test receives FDA 510(k) clearance

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BioMérieux has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its assay that screens for mild traumatic brain injury (mTBI), including concussion.

The BioMérieux Vidas TBI test measures the concentration of two biomarkers, GFAP and UCH-L1, that are released into the bloodstream for up to 12 hours after a brain injury. It runs on the firm's Vidas 3 and Vidas Kube immunoanalyzers.

The Vidas TBI assay received the CE Mark in October 2023; it is currently commercialized in select European, North African, and South American countries, according to a statement from BioMérieux.

Suspected TBIs are a frequent reason for ED visits, with mTBIs accounting for 70% to 90% of all TBI diagnoses. According to BioMérieux, an estimated 90% of mTBI patients who undergo computed tomography (CT) scans will be negative for abnormal findings; however, approximately 82% of all TBI patients presenting in emergency departments receive CT scans.

Because the test can aid in ruling out acute intracranial lesions when used with other clinical data, it can help reduce the number of unnecessary, expensive, time- and labor-intensive CT scans employed in the ED, according to BioMérieux. The company said it plans to launch the test commercially in the U.S. in the latter half of 2024.

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