FDA approves first blood test for concussions
The Food and Drug Administration on Wednesday approved a long-awaited blood test to detect concussions in people and more quickly identify those with possible brain injuries.
The test, called the Banyan Brain Trauma Indicator, is also expected to reduce the number of people exposed to radiation through CT scans, or computed tomography scans, that detect brain tissue damage or intracranial lesions. If the blood test is adopted widely, it could eliminate the need for CT scans in at least a third of those with suspected brain injuries, the agency predicted.
Concussion-related brain damage has become a particularly worrisome public health issue in many sports, especially football, affecting the ranks of professional athletes on down to the young children in Pop Warner leagues. Those concerns have escalated so far that it has led to a decline in children participating in tackle sports.
“This is going to change the testing paradigm for suspected cases of concussion,” said Tara Rabin, a spokeswoman for the FDA. She noted that the agency had worked closely on the application with the Defense Department, which has wanted a diagnostic tool to evaluate wounded soldiers in combat zones. The Pentagon financed a 2,000person clinical trial that led to the test’s approval.
According to the Centers for Disease Control and Prevention, there were about 2.8 million visits to emergency rooms for traumatic brain injuryrelated conditions in 2013, the most recent year for which the numbers were available. Of these, nearly 50,000 people died. Most patients with suspected traumatic brain injury are evaluated using a neurological exam, followed by a CT scan.
One of the challenges of diagnosing concussions is that symptoms can occur at different times. In some people, they appear instantly, while in others they can show up hours or even days later. Symptoms also vary from person to person. Some experience sensitivity to noise, others lose their balance, and still others become sensitive to bright light.
“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, director of the FDA’s medical device division. The agencynoted that it had cleared this diagnostic device in less than six months.
The test works by measuring the levels of proteinsthat are released from the brain into blood and measured within 12 hours of the head injury. Levels of these blood proteins can help predict which patients may have intracranial lesions visible by CT scan, and which won’t.