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Banyan Biomarkers Reports Successful Clinical Trial Results of Blood Test to Evaluate Mild and Moderate Traumatic Brain Injury

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Banyan Biomarkers, Inc., the leader in developing biomarkers for traumatic brain injury (TBI), today announced the results of a clinical study utilizing a blood test to evaluate mild and moderate TBI. The results, published online in the Journal of Neurotrauma, indicate that the two highly brain specific biomarkers in Banyan Biomarkers’ blood test, ubiquitin c-terminal hydrolase-L 1 (UCH-L1) and glial fibrillary acidic protein (GFAP), are detectable in blood shortly after a TBI. The test was able to identify 100% of the trial subjects who went on to have a positive computed tomography (CT) scan of the head. The results demonstrate that early biomarker testing for patients with mild to moderate TBI has the potential to provide clinicians with objective evidence needed to reduce CT use that is associated with increased healthcare costs and developing cancer over the long term.
This prospective multi-center observational study included 251 patients with mild to moderate TBI who presented to seven emergency departments in the United States and Europe. All patients in the study underwent a CT scan as part of routine care and had blood drawn for biomarker analysis within six hours of injury.

“This study is an important step in developing an objective test for the evaluation of TBI patients. An objective blood test for TBI has the potential to improve evaluation and clinical outcomes for millions of people that suffer a head injury each year,” stated lead author Robert Welch MD, Professor of Emergency Medicine at Wayne State University.

According to the paper, the results demonstrate that within six hours of injury, UCH-L1 was very sensitive in identifying patients with a positive CT scan of the head. The authors also analyzed S100B, another potential blood based biomarker for TBI, and determined that S100B was not able to achieve the same performance as UCH-L1.

“This study represents a major milestone for Banyan Biomarkers and we look forward to the results of our 2,000 subject confirmatory pivotal study that will be released next year,” stated Jackson Streeter MD, CEO of Banyan Biomarkers.

The study was supported by the US Army Medical Research and Materiel Command and published online in the Journal of Neurotrauma, 2015 Oct 15. [Epub ahead of print]

Study: Ability of Serum Glial Fibrillary Acidic Protein, Ubiquitin C-Terminal Hydrolase-L1, and S100B to Differentiate Normal and Abnormal Head Computed Tomography Findings in Patients with Suspected Mild or Moderate Traumatic Brain Injury [Journal of Neurotrauma]

Source: Business Wire