BioMérieux Gets CE Mark for Traumatic Brain Injury Immunoassay

Original from: 360dx

BioMérieux announced on Friday that it has obtained CE marking for an assay to detect two biomarkers associated with mild traumatic brain injury (mTBI). Commercial launch of the test is planned in selected European, North African, and South American markets in the last quarter of 2023, the firm said in a statement, and in the rest of the world throughout 2024 and 2025.  

TBI is considered a major public health burden impacting 69 million people globally per year, with as many as 90 percent of cases classed as mild on a head injury measure named the Glasgow Coma Scale. 

The BioMérieux Vidas TBI (GFAP, UCH-L1) measures the concentration of two biomarkers released into the bloodstream for up to 12 hours following a brain injury. 

The test runs on the firm's Vidas 3 and Vidas Kube immunoanalyzers which can enable around-the-clock, on-demand automated testing, BioMérieux said in a statement. The Vidas platform was launched more than 30 years ago and is the most widely used immunoassay system in clinical laboratories worldwide, the firm said, with a menu of chronic and infectious disease assays and a range of tests dedicated for emergency and critical care. The Vidas Kube, which the firm debuted in 2022, is expected to eventually replace its Mini Vidas and Vidas instruments.

The TBI test results can be used along with other clinical information to rule out the presence of intracranial lesions, potentially obviating the need for head CT scans or other costly or invasive procedures in the emergency department, BioMérieux said in a statement.

"Vidas TBI (GFAP, UCH-L1), in combination with a clinical evaluation, provides an objective and accurate blood test result for optimal mTBI management to help clinicians perform fast and efficient ED patient screening with confidence, optimizing CT-scan usage and improving the standard of patient care," Mark Miller, executive VP and chief medical officer at BioMérieux, said in a statement.

Jennifer Zinn, executive VP of clinical operations, added that the test "could be a real game changer" for emergency departments assessing mTBI cases. "It's an important innovation that further strengthens the Vidas test range for emergency and critical care," Zinn added. 

BioMérieux partnered with Banyan Biomarkers in 2017 to commercialize its TBI assay. Banyan obtained clearance from the US Food and Drug Administration for the a 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 iSTAT system as well as a lab-based TBI test.

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Source: BioMérieux Gets CE Mark for Traumatic Brain Injury Immunoassay