FDA OK's Banyan Diagnostic, the First Blood Test for Concussions

The Blood Tests To Diagnose Brain Injury Are Now Approved By The FDA

The move means Banyan Biomarkers can commercialize its test, giving the San Diego-based company an edge in the biotech industry's race to find a way to diagnose concussions. This fast approval was probably influenced by the Military necessity for such blood tests.

"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", Scott Gottlieb, MD, FDA Commissioner, said in a statement.

The test is created to detect two brain cells' proteins that can drain into the bloodstream after a head injury. Banyan's research shows the test can detect them within 12 hours of injury. And traumatic brain injuries (TBIs) helped kill almost 50,000 people that year.

"In addition, availability of a blood test for mTBI/concussion 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 test", Gottlieb added. The Centers for Disease Control and Prevention has estimated that in 2013, there were roughly 2.8 million emergency department visits, hospitalizations and deaths in the US related to traumatic brain injury, or TBI. And for children, whose bodies are smaller and whose brains are still developing, the widening use of CT scans has raised particular alarms.

CT scan, in fact, was, until now, the only existing method to confirm the preliminary diagnosis of brain injury but it does have one big downside, namely radiation exposure. He pointed out that we need better measurements to understand when brains have fully healed from trauma, as well as a better understanding of how these biomarkers act which may actually affect prognosis. Knowledge of these blood protein levels allows health care professionals to predict the probability of intracranial lesions showing up on a CT scan, according to the FDA.

The first blood test created to help doctors evaluate whether a suspected brain injury is a concussion has been approved by the U.S.

The US Food and Drug Administration has approved the first blood test made to help doctors assess whether or not a brain injury is a concussion. Most people who present with concussion symptoms, like impaired memory, problems with movements or sensations, or compromised emotional function, turn out to have negative CT scans, the FDA said. "It's not the pot of gold at the end of the rainbow", Koroshetz said. A blow to the head can cause the proteins to leak into the bloodstream.



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