bioMérieux, a leading figure in in vitro diagnostics, has just received clearance from the U.S. FDA for VIDAS® TBI (GFAP, UCH-L1), a serum-based test designed to aid in the assessment of patients with mild traumatic brain injury (mTBI), commonly known as concussion. This test utilizes a distinctive combination of two biomarkers, GFAP and UCH-L1, which are proteins released into the bloodstream following cellular injury. By leveraging these biomarkers, the assay aims to reduce the necessity for head Computed Tomography (CT) scans for mTBI patients by predicting the absence of acute intracranial lesions (ICL).
Traumatic brain injury occurs when external mechanical energy is transferred to brain tissue, resulting in cellular damage and dysfunction. It represents a significant public health burden, with approximately 69 million individuals affected worldwide annually. Mild traumatic brain injuries constitute the majority of TBI cases, ranging from 70-90%, although they are less likely to lead to acute medical emergencies compared to moderate or severe cases.
Despite the lower likelihood of significant findings, CT scans are still commonly performed in mTBI cases, with an estimated 82% of patients undergoing such scans. This overuse of imaging not only prolongs patient workup time but also exposes individuals to unnecessary radiation and consumes resources.
VIDAS® TBI (GFAP, UCH-L1) presents a breakthrough in triaging mTBI cases efficiently. Operating within a testing window of up to 12 hours post-injury, this immunoassay measures the concentration of GFAP and UCH-L1 in the bloodstream. When combined with clinical data, the results assist clinicians in deciding whether a CT scan is warranted, potentially shortening emergency department (ED) workup time.
Colin Hill, General Manager and Head of Clinical Operations, North America, expressed the significance of this FDA clearance, highlighting its role in enabling swift and informed decision-making for personalized patient treatment. Dr. Charles K. Cooper, Executive Vice President and Chief Medical Officer, emphasized bioMérieux’s commitment to developing diagnostic solutions that enhance healthcare delivery and contribute to societal well-being.
Available on VIDAS® 3 and VIDAS® KUBE™ immunoanalyzers, VIDAS® TBI (GFAP, UCH-L1) offers automated testing round-the-clock. The assay is slated for commercial launch in the United States in the latter half of 2024 and is already CE-marked and available in select European, North African, and South American countries.