In a press release, FDA Commissioner Scott Gottlieb said that this product could save the health care system money by preventing unnecessary neuroimaging tests.
Gottlieb, who called the Trauma Indicator part of a federal push to "ensure that each patient is getting the right imaging exam, at the right time, with the right radiation dose", also said the new approach to concussion analysis will likely reduce the number of CT scans performed each year, cutting healthcare costs.
Alberts said it will be most useful in the case of mild head injuries, when there's doubt about whether someone has a concussion.
Dr. Walter Koroshetz, director of the National Institute of Neurological Disorders and Stroke, and other brain injury experts say the test isn't sensitive enough to rule out concussions. Its developers, Banyan Biometrics scientists, stated that their blood test can diagnose concussions within 12 hours after the injury occurred. A blood-testing option for the evaluation of mTBI/concussion 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.
Almost 2.8 million people visited US emergency rooms in 2013 because of concussion or other traumatic brain injuries, according to the Centers for Disease Control and Prevention.
Currently, it's routine to order a CT scan for all patients with suspected closed head injuries, the FDA noted, but most scans do not show detectable lesions. "It's expensive; it's not terrific", said Hank Nordhoff, chairman and CEO of Banyan Biomarkers, maker of the new test.
Banyan's blood test is created to cut the need for CT scans.
When compared with a CT scan, the blood test was 97.5 percent as effective in detecting concussion and 99.6 percent effective in ruling out concussion.
The FDA's marketing authorization was supported by data from a multi-center, prospective clinical study involving 1,947 blood samples from adults with suspected mTBI/concussion. The impact will be improved medical care by reducing radiation exposure to the patient and improving efficiency in the emergency department, ' stated Andy Jagoda, MD, Professor and Chair in the Department of Emergency Medicine at the Icahn School of Medicine at Mount Sinai.
Because of the US military's role in the new test's development, Nordhoff noted that clinical trials have enrolled adults only. In doing so, the screen could avoid CT scans for one-third of people who have a possible mild traumatic brain injury.