Innovative Test Improves Assessment of Patients with Mild Traumatic Brain Injury

Traumatic brain injury (TBI) occurs when external mechanical energy is transferred to brain tissue, causing cellular damage, dysfunction, and dysregulation. It is a significant public health issue, being a leading cause of death and disability globally, with approximately 69 million people affected each year. For clinicians assessing these patients, it is crucial to quickly ascertain the presence or absence of potentially life-threatening hemorrhages and neurological complications. TBI severity is evaluated using the Glasgow Coma Scale (GCS) and categorized as mild, moderate, or severe. Mild traumatic brain injuries (mTBI) are the most common, comprising 70-90% of all TBI cases, and they are the least likely to lead to acute medical emergencies. It is noted that about 90% of mTBI patients who receive computed tomography (CT) scans show no abnormal findings. Despite this, an estimated 82% of all TBI patients are scanned, many of which could potentially be unnecessary. These scans not only increase the time to diagnose but also expose patients to radiation and utilize significant resources from already strained emergency departments (ED). Now, an innovative test aims to improve the assessment of patients with mTBI.

The VIDAS® TBI (GFAP, UCH-L1) from bioMérieux (Marcy-l’Étoile, France) is a serum-based test to support the assessment of patients with mTBI, including concussion. The assay uses a unique combination of the biomarkers GFAP and UCH-L1, proteins that enter circulation following cellular injury. When used in conjunction with clinical information, VIDAS® TBI (GFAP, UCH-L1) results can aid clinicians in determining the need for CT imaging of the head in adult patients (18 years or older), presenting within a large testing window of up to 12 hours after injury, and help shorten ED workup time. A negative test result assists in determining the need for a CT-scan by predicting the absence of ICL. VIDAS® TBI (GFAP, UCH-L1) is available on VIDAS® 3 and VIDAS® KUBE™ immunoanalyzers, offering on-demand automated testing 24/7. bioMérieux has received the U.S. FDA 510(k) clearance of VIDAS® TBI (GFAP, UCH-L1) and has planned the assay’s commercial launch for the second half of 2024 in the United States. VIDAS® TBI (GFAP, UCH-L1) is also CE-marked and commercialized in selected European, North African and South American countries.

Image: The VIDAS® TBI (GFAP, UCH-L1) has received US FDA 510(k) clearance (Photo courtesy of bioMérieux)

“Securing FDA clearance for the VIDAS® TBI (GFAP, UCH-L1), marks another significant milestone in our journey toward innovative solutions for our customers and improving patient outcomes,” said Colin Hill, General Manager and Head of Clinical Operations, North America. “This enables clinicians to confidently perform fast, efficient triage for mTBI’s, resulting in faster and more informed decisions for personalized treatment of patients.”

“In keeping with the legacy of bioMérieux, we remain committed to developing diagnostic solutions that will improve the delivery of healthcare, have a positive societal impact, and help make the world a healthier place,” said Dr. Charles K. Cooper, Executive Vice President and Chief Medical Officer. “In recognizing the enormity of traumatic brain injury, the VIDAS® TBI (GFAP, UCH-L1) assay contributes to the advancement of current practices in disease evaluation.”