"The U.S. Food and Drug Administration today permitted marketing of the first blood test to evaluate mild traumatic brain injury mTBI commonly referred to as concussion in adults. The FDA reviewed and authorized for marketing the Banyan Brain Trauma Indicator in fewer than  months as part of its Breakthrough Devices Program https Most patients with a suspected head injury are examined using a neurological scale called the point Glasgow Coma Scale followed by a computed tomography or CT scan of the head to detect brain tissue damage or intracranial lesions that may require treatment however a majority of patients evaluated for mTBIconcussion do not have detectable intracranial lesions after having a CT scan. Availability of a blood test for concussion will help health care professionals determine the need for a CT scan in patients suspected of having mTBI and help prevent unnecessary neuroimaging and associated radiation exposure to patients. Helping to deliver innovative testing technologies that minimize health impacts to patients while still providing accurate and reliable results to inform appropriate evaluation and treatment is an FDA priority. Todays action supports the FDAs Initiative to Reduce Unnecessary Radiation Exposure from Medical Imagingan effort to ensure that each patient is getting the right imaging exam at the right time with the right radiation dose said FDA Commissioner Scott Gottlieb M.D. A bloodtesting option for the evaluation of mTBIconcussion not only provides health care professionals with a new tool but also sets the stage for a more modernized standard of care for testing of suspected cases. In addition availability of a blood test for mTBIconcussion will likely reduce the CT scans performed on patients with concussion each year potentially saving our health care system the cost of often unnecessary neuroimaging tests. According to the U.S. Centers for Disease Control and Prevention in  there were approximately . million TBIrelated emergency department visits hospitalizations and deaths in the U.S. Of these cases TBI contributed to the deaths of nearly  people. TBI is caused by a bump blow or jolt to the head or a penetrating head injury that disrupts the brains normal functioning. Its severity may range from mild to severe with  percent of TBIs that occur each year being assessed as mTBIs or concussions. A majority of patients with concussion symptoms have a negative CT scan. Potential effects of TBI can include impaired thinking or memory movement sensation or emotional functioning. A blood test to aid in concussion evaluation is an important tool for the American public and for our Service Members abroad who need access to quick and accurate tests said Jeffrey Shuren M.D. director of the FDAs Center for Devices and Radiological Health. The FDAs review team worked closely with the test developer and the U.S. Department of Defense to expedite a blood test for the evaluation of mTBI that can be used both in the continental U.S. as well as foreign U.S. laboratories that service the American military. The Brain Trauma Indicator works by measuring levels of proteins known as UCHL and GFAP that are released from the brain into blood and measured within  hours of head injury. Levels of these blood proteins after mTBIconcussion can help predict which patients may have intracranial lesions visible by CT scan and which wont. Being able to predict if patients have a low probability of intracranial lesions can help health care professionals in their management of patients and the decision to perform a CT scan. Test results can be available within  to  hours. The FDA evaluated data from a multicenter prospective clinical study of  individual blood samples from adults with suspected mTBIconcussion and reviewed the products performance by comparing mTBIconcussion blood tests results with CT scan results. The Brain Trauma Indicator was able to predict the presence of intracranial lesions on a CT scan . percent of the time and those who did not have intracranial lesions on a CT scan . percent of the time. These findings indicate that the test can reliably predict the absence of intracranial lesions and that health care professionals can incorporate this tool into the standard of care for patients to rule out the need for a CT scan in at least onethird of patients who are suspected of having mTBI. The Brain Trauma Indicator was reviewed under the FDAs De Novo premarket review pathway a regulatory pathway for some low to moderaterisk devices that are novel and for which there is no prior legally marketed device. The FDA is permitting marketing of the Brain Trauma Indicator to Banyan Biomarkers Inc. The FDA an agency within the U.S. Department of Health and Human Services protects the public health by assuring the safety effectiveness and security of human and veterinary drugs vaccines and other biological products for human use and medical devices. The agency also is responsible for the safety and security of our nations food supply cosmetics dietary supplements products that give off electronic radiation and for regulating tobacco products."