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Banyan Biomarkers Reports Successful Clinical Trial Results of Blood Test to Evaluate Mild and...

Thursday, November 5, 2015   (0 Comments)
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Banyan Biomarkers Reports Successful Clinical Trial Results of Blood Test to Evaluate Mild and Moderate Traumatic Brain Injury

SAN DIEGO--()--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 costs1 and developing cancer over the long term.2

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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]

About TBI

According to the Center for Disease Control and Prevention, TBI is a major cause of disability and death, and affects over 2.5 million people each year in the United States. A TBI results from a bump, blow, or jolt to the head that disrupts the normal function of the brain. Automobile accidents, falls, sports related injuries, and assaults are the common causes of TBI.3

Currently, there is no objective test for physicians to detect the presence and severity of brain trauma and, since 80-90% TBIs are mild to moderate4, rarely present any evidence on a CT scan.5 There has been a 30% increase in emergency room visits in the last year due to heightened awareness of associated risks of concussions and downstream neurological deficits that result from repetitive brain trauma.6

About Banyan Biomarkers

Banyan Biomarkers, Inc. is focused on developing a simple point-of-care diagnostic blood test that could be used by physicians to rapidly detect the presence of mild and moderate brain trauma and improve the medical management of head injured patients. The Company’s test detects two proteins (UCH-L1 and GFAP) in blood, which are normally present in the brain and cross the blood brain barrier after head injury. To learn more about Banyan Biomarkers, visit www.banyanbio.com.

References

1. Injury Prevention and Control: Traumatic Brain Injury. Centers for Disease Control and Prevention. Website: http://www.cdc.gov/TraumaticBrainInjury/severe.html. Accessed: November 4, 2015.

2. The Surprising Dangers of CT Scans and X-rays. Website: http://www.consumerreports.org/cro/magazine/2015/01/the-surprising-dangers-of-ct-sans-and- x-rays/index.htm. Accessed: November 4, 2015.

3. Injury Prevention and control: Traumatic brain injury in the United States. Fact sheet. Centers for Disease Control and Prevention. Website: www.cdc.gov/traumaticbraininjury/get_the_facts.html. Accessed: November 4, 2015.

4. Saatman KE et al. Classification of Traumatic Brain Injury for Targeted Therapies. J Neurotrauma. 2008;25:719-738.

5. Neurology Reviews: MRI Improves Long-Term Outcome Prediction for Patients With Mild Traumatic Brain Injury. Website: http://www.neurologyreviews.com/the-publication/past-issue-sngle-view/mri-improves-long-term- outcome-prediction-for-patients-with-mild-traumatic-brain-injury/bf699d7ef93eb69f457faf0ca964e650.html. Accessed: November 4, 2015.

6. Stern RA et al. Long-term consequences of repetitive brain trauma: chronic traumatic encephalopathy. PM&R. 2011 Oct;3(10 Suppl 2):S460-7.

Contacts

Banyan Biomarkers, Inc.
Tony Grover, 760-710-0423
Vice President of Business Development
tgrover@banyanbio.com


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