BioMérieux Receives CE Mark for Biomarker Assay for Mild TBI

BioMérieux has obtained the CE Mark for its assay to detect two biomarkers associated with mild traumatic brain injury (mTBI). On commercial products, the presence of the CE Mark indicates the manufacturer or importer of that product affirms it complies with European Union legislation.

In a statement, the company said that the commercial launch of the test in selected European, North African, and South American markets is planned for the last quarter of 2023; the firm plans to launch the test in the rest of the world throughout 2024 and 2025.

BioMérieux signed an agreement with UF startup Banyan Biomarkers in 2017 to commercialize Banyan’s TBI assay. In 2018, Banyan’s GFAP and UCH-L1 biomarker-based brain trauma indicator test received U.S. Food and Drug Administration (FDA) clearance.

Banyan Biomarkers licensed technology discovered by Kevin Wang, Ronald Hayes, and Stanislav Svetlov and their team of inventors in the College of Medicine and IFAS. The company incubated at UF Innovate | Accelerate at Sid Martin Biotech.

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