Banyan Biomarkers, Inc. Targets Protein Biomarkers to Detect Mild to Moderate Traumatic Brain Injury
I found this news release of interest.
Banyan Biomarkers, Inc. today announced initiation of a multi-center, clinical feasibility study designed to demonstrate the effectiveness of the Company’s proprietary protein biomarkers, in detecting mild or moderate traumatic brain injury (MTBI). Banyan Biomarkers’ study will test a panel of biomarkers in blood from several hundred MTBI patients. The U.S. Department of Defense is providing funding to the Company to support the study. The results of the MTBI study will be submitted to the FDA in preparation for an Investigational Device Exemption pivotal trial. Ultimately, Banyan Biomarkers’ goal is to receive FDA approval for the Company’s biomarkers to be used as in vitro diagnostic blood tests for detecting mild to moderate brain injury.
The decision to fund the MTBI clinical study is based on positive data from an ongoing interim analysis currently being conducted by Banyan Biomarkers to assess the sensitivity and specificity of biomarkers in detecting and managing severe brain injury. The U.S. Department of Defense also funded Banyan Biomarkers’ severe brain injury study.
Of the 1.5 million traumatic brain injuries sustained annually in the United States, at least 75% are MTBI, also known as concussion. Physicians have difficulty diagnosing concussions since magnetic resolution images (MRI) and computed technology (CT) scans typically do not reveal concussions.
Gary Ascani, President and Chief Executive Officer, Banyan Biomarkers, Inc., commented, “Since there is currently no FDA cleared blood test to detect traumatic brain injury, Banyan is very gratified that the U.S. Department of Defense continues to fund our important work in this area. The military’s need for a rapid diagnostic test for use in accurately evaluating our injured soldiers will also provide an important tool needed by doctors treating civilians in the emergency room.”
Banyan Biomarkers is the leader in developing in vitro diagnostic products to address unmet clinical needs for the detection of traumatic brain injury. The Company is focused on developing a simple point-of-care blood test that will be used by physicians to detect the presence and severity of brain trauma and improve the medical management of head injured patients. Banyan Biomarkers has a licensing agreement with the University of Florida for exclusive global use of technology related to this product. To learn more about Banyan Biomarkers, Inc., visit http://www.banyanbio.com.
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