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BioMérieux TBI Immunoassay Gets FDA 510(k) Clearance

NEW YORK – BioMérieux announced Tuesday that it has received 510(k) clearance from the US Food and Drug Administration for an immunoassay to detect two protein biomarkers associated with mild traumatic brain injury (mTBI).

The BioMérieux Vidas TBI (GFAP, UCH-L1) test measures the concentrations of glial fibrillary acidic protein and ubiquitin C-terminal hydrolase-L1 in blood serum. It can be used between one and 12 hours after injury and runs on the firm's Vidas 3 and Vidas Kube immunoanalyzers.

The test, which was also CE marked in October, is expected to shorten head injury work-up time in emergency departments and reduce unnecessary computed tomography (CT) testing in mTBI cases.

The test "enables clinicians to confidently perform fast, efficient triage for mTBIs, resulting in faster and more informed decisions for personalized treatment of patients," said Colin Hill, BioMérieux's general manager and head of clinical operations for North America.

Mild TBI accounts for up to 90 percent of all TBI diagnoses. Approximately 82 percent of all TBI patients get a CT scan, according to a study of emergency department TBI evaluation, but 90 percent of patients will be negative for abnormal findings.

BioMérieux plans to launch the test commercially in the US during the second half of 2024.

As previously reported, BioMérieux partnered with Banyan Biomarkers in 2017 to commercialize its TBI assay. Banyan obtained clearance from the FDA for the GFAP and UCH-L1 biomarker-based test in 2018. It also nonexclusively licensed the test to Abbott in 2019, and that firm subsequently obtained FDA clearance for a rapid handheld TBI test on its I-STAT system as well as a lab-based TBI test.