bioMérieux Receives CE-Marking for Blood Test for Traumatic Brain Injury

bioMérieux has announced the CE-marking of VIDAS® TBI (GFAP, UCH-L1), a new blood test designed to aid in the assessment of patients with mild traumatic brain injury (mTBI). The test utilizes a combination of brain biomarkers, GFAP and UCH-L1, and aims to reduce the number of unnecessary head Computed Tomography (CT) scans carried out for mTBI patients. Moreover, it aims to alleviate the strain on Emergency Departments (ED) by accurately predicting the absence of acute intracranial lesions (ICL) following head trauma.

Traumatic brain injury (TBI), defined as an impairment in brain function resulting from external forces, constitutes a substantial public health challenge, with an estimated 69 million individuals affected by it annually and in the United States there were 2.8 million TBI cases. Based on the clinical presentation and severity assessment using the Glasgow Coma Scale (GCS), TBIs are classified into mild, moderate, or severe categories. 70 to 90% of all TBIs fall under the mild category, making them one of the most prevalent reasons for patient visits to EDs.

Head CT-scans are a mandatory requirement in cases of moderate and severe TBI. However, in situations involving mTBI, physicians often resort to CT scans in the initial evaluation to identify potential post-traumatic intracranial lesions. Regrettably, ICLs are present in fewer than 10% of mTBI cases, leading to an unnecessary number of scans. These additional scans not only elongate patient workup times but also subject patients to CT-scan radiation while overburdening ED departments. The American Academy of Neurology updated its concussion guidelines in 2013, revising the earlier version from 1997. The updated guidelines emphasize that concussion is primarily a clinical diagnosis and advise against the routine use of CT scans for diagnosing sports-related concussions. However, they do acknowledge that CT scans may be considered when there are concerns about more severe traumatic brain injuries, such as intracranial hemorrhage, in athletes suspected of having a concussion and exhibiting specific indicators. These indicators include loss of consciousness (LOC), posttraumatic amnesia, persistently altered mental status (measured by a Glasgow Coma Scale [GCS] score below 15), focal neurologic deficits, clinical evidence of skull fracture during examination, or signs of deteriorating clinical condition.

VIDAS® TBI (GFAP, UCH-L1) can be used by emergency departments to rule out ICLs. The test evaluates the concentration of GFAP and UCH-L1, two brain biomarkers released into the bloodstream within the first hour following a brain injury. Offering a wide testing window of up to 12 hours after the injury. VIDAS® TBI (GFAP, UCH-L1) is available on VIDAS® 3 and VIDAS® KUBE™ immunoanalyzers, offering on-demand automated testing 24/7. The test is set to be commercially launched in select European, North African, and South American markets in the final quarter of 2023, with plans for global expansion throughout 2024 and 2025.

Mark Miller, Executive Vice President and Chief Medical Officer at bioMérieux, emphasized the importance of quick decisions made by ED physicians for the benefit of patients and streamlined patient management in EDs. Notably, around 90% of mTBI cases show no abnormalities, highlighting the value of VIDAS® TBI (GFAP, UCH-L1) in conjunction with clinical assessments as a reliable and objective blood test result. This combination optimizes CT-scan usage, enhances patient care standards, and provides ED clinicians with greater confidence in fast and efficient patient screening.