The FDA released a Press Announcement authorizing the marketing of the first-ever blood test used to evaluate concussions in adults this past Wednesday. If the blood test, named the Banyan Brain Trauma Indicator (BTI), is conducted within 12 hours of the head injury, the protein levels of UCH-L1 and GFAP can be used to determine if a patient is suffering from a concussion. These proteins are released by the brain into the bloodstream at elevated levels after a concussion or nerve fiber damage. Results of the blood test are given within three to four hours, and it is expected that improvements on the BTI will reduce the time to less than an hour within the year.
Currently, many suspected concussion patients use CT scans that detect brain tissue damage and intracranial lesions that occur in the event of a concussion. CT scans are quite effective but expose patients to radiation and are in the higher price range for patients. Using the BTI will reduce the exposure to radiation but will also urge those with suspected concussions to get the testing and treatment necessary for healing.
After 1,947 clinical studies, it was found that the BTI test was able to detect confirmed concussions 97.5% of the time and was able to correctly produce a negative result 99.6% of the time. These findings showed that the test can reliably predict concussions and that the BTI test is a reliable tool for doctors and other medical professionals to use as an alternative to the CT scans.
The FDA approval of the BTI test comes at a time of reports of concussions doubling from 2001 to 2012 and the increased awareness of the potentially life-threatening repercussions of brain injuries. Nearly 2.8 million emergency room visits in 2013 were related to traumatic brain injuries in the United States, and nearly 50,000 people have died due to concussions according to the CDC. Although this blood test will change the manner and speed with which medical professionals are able to effectively diagnose and treat concussions, some professionals are concerned that the FDA approval was much too hasty and that more time will be needed to develop more reliable blood tests.
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