A multi-centre, clinical feasibility study has been started by Banyan Biomarkers to demonstrate the effectiveness of protein biomarkers in detecting mild or moderate traumatic brain injury (MTBI).
The study focuses on developing a simple point-of-care blood test that can be used by physicians to detect the presence and severity of brain trauma, improving the medical management of head injured patients.
It involves testing a panel of biomarkers in blood from several hundred MTBI patients as magnetic resolution images (MRI) and computed technology (CT) scans typically do not reveal concussions.
The results of the MTBI study, which will use the company’s protein biomarkers in vitro diagnostic blood tests, will be submitted to the US FDA for approval.
The US Department of Defense has been funding the company to support the study.
Banyan Biomarkers president and chief executive officer, Gary Ascani said: “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.”
The US faces 1.5 million traumatic brain injuries every year, of which almost 75% occur due to MTBI.
By staff writer.