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FDA Clears First Blood Test for Concussions

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(Skeeze, Pixabay)

14 February 2018. The Food and Drug Administration authorized for marketing in the U.S. a blood test that screens for chemical indicators in the blood for concussions, a form of traumatic brain injury. The agency says the test made by Banyan Biomarkers Inc. in San Diego, is the first of its kind cleared to screen for concussions.

Traumatic brain injuries result from blows to the head, including those from contact sports, or penetrations of the skull that disrupt normal brain functions. Centers for Disease Control and Prevention says traumatic brain injuries contribute to 30 percent of all deaths from injuries, which for survivors can lead to disruptions in thinking, memory, movement, sensations, or emotional functions. CDC estimates in 2013, traumatic brain injuries accounted for 2.8 million emergency room visits, hospitalizations, and deaths.

Concussion is the term used for milder traumatic brain injuries, resulting in a brief change in mental status or consciousness, and according to Banyan Biomarkers, account for nearly all (95%) of  traumatic brain injury cases. Most concussions are screened today with the Glascow Coma Scale, a written scale of items that evaluates an individuals level of consciousness after a suspected brain injury, covering eye movements, verbal responses, and motor responses. If a person’s score on the scale exceeds a designated threshold, a computed tomography or CT scan of the head is requested to detect brain lesions or tissue damage.

Most concussions, however, do not result in damage to brain tissue, thus returning negative CT scan results. The Banyan Brain Trauma Indicator, says the company, is designed to provide an objective and less expensive alternative to CT scans. The test looks for the presence of 2 brain-specific proteins in a person’s blood sample: ubiquitin c-terminal hydrolase-L1 and glial fibrillary acidic protein. Both proteins are found in the brain, but when damage to the brain occurs, can spill out into the blood stream. The test is administered within 12 hours of a suspected concussion, with results returned in 3 to 4 hours.

FDA based its clearance of the test on a clinical trial completed in 2017 with 2,011 participants in the U.S. and Europe suspected of having a concussion. The study, co-sponsored by the U.S. Department of Defense, aimed to determine the value of the Banyan blood test as a way to more accurately determine the need for CT scans. The results show positive results on the Banyan test accurately predict the presence of brain tissue damage in CT scans 98 percent of the time, while negative results forecast the lack of brain lesions in more than 99 percent of cases.

The agency says it reviewed Banyan’s application in less than 6 months, as part of FDA’s Expedited Access Pathway Program, created by Congress in 2016 under the 21st Century Cures Act. One of the benefits of the Banyan test, noted in the agency announcement, is a reduced need for CT scans, which addresses another FDA priority, preventing unnecessary neuroimaging and associated radiation exposure to patients. “Today’s action,” says FDA Commissioner Scott Gottlieb, “supports the FDA’s Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging, an effort to ensure that each patient is getting the right imaging exam, at the right time, with the right radiation dose.”

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