May 28, 2024—BioMérieux received FDA 510(k) clearance for its Vidas TBI (GFAP, UCH-L1), a serum-based test that supports the assessment of patients with mild traumatic brain injury, including concussion. The assay measures the concentration of GFAP and UCH-L1, proteins that enter circulation following cellular injury. When used in conjunction with clinical information, results from the Vidas TBI test can aid clinicians in determining the need for CT imaging of the head in patients 18 years or older up to 12 hours after injury. A negative test result assists in determining the need for a CT scan by predicting the absence of acute intracranial lesions.
Commercial launch of the assay in the United States is planned for the second half of this year. It is available on Vidas 3 and Vidas Kube immunoassay analyzers.