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News: FDA Approves New Blood Test to Help ID Concussions

News: FDA Approves New Blood Test to Help ID Concussions

Results take just a few hours—and they're nearly 100 percent accurate.

A new blood test to evaluate mild traumatic brain injury (TBI), also known as a concussion, has been approved by the Food and Drug Administration (FDA). Called the Banyan Brain Trauma Indicator, the highly reliable test produces results within a few hours, and can help reduce unnecessary computed tomography (CT) scans and guide treatment of TBIs.

In 2013, the most recent year for which data is available, TBIs led to about 2.5 million US emergency department visits, according to the Centers for Disease Control and Prevention (CDC). About 282,000 more people were hospitalized, and an additional estimated 56,000 died.

How the test works
Currently, the default mode for doctors caring for head injury patients is to order a CT scan, which helps them decide how serious the injury is. However, more than 90 percent of those who come to the ER with a mild TBI have negative scans, according to Banyan Biomarkers, Inc. Their test, which indicates whether there is likely to be a brain lesion that needs treatment, may help slash the number of those scans, saving both time and money.

"It doesn't diagnose a concussion, but it helps in the evaluation of individuals with suspected concussion in deciding whether to obtain a CT scan," says John Kuluz, MD, director of traumatic brain injury and neurorehabilitation at Nicklaus Children's Hospital in Miami.

To do this, the test measures the levels of two proteins, UCH-L1 and GFAP, released from the brain into the blood after a head injury. When measured within 12 hours of the injury, the levels can predict which people may have intracranial lesions as a result of the blow.

"If these proteins are elevated, you should get a CT scan," Dr. Kuluz says. "It is going to show you the location and size and severity of the trauma."

If the protein levels are not elevated, ''It means you can forego the CT scan because the data show that the likelihood of having an abnormality on the CT scan is low," he says. "You could still have a concussion."

Avoiding radiation is another benefit of the new test. The average amount of radiation in a CT scan of the head is about two millisieverts, the measure used. A traditional chest X-ray is 0.1 millisieverts.

The FDA approval process
The FDA greenlit the test—in less than six months—after evaluating data from a study of nearly 2,000 blood samples from adults with suspected mild concussion. They compared the blood test results with the CT scan results. The blood test was able to predict the presence of brain lesions 97.5 percent of the time when they were present, and predicted the absence of them 99.6 percent of the time.

The new test is approved for adults only at this time. Results take about three to four hours, but the company says it is working on reducing that time. It has licensed the test to two companies. One of the companies, Abbott, says it is developing a version of the test that can be done on a handheld device, with results in less than 15 minutes. It predicts that version will be available in one or two years.

Reducing the results time is important, Kuluz says, as emergency departments are under pressure to move patients in and out effectively and quickly.

According to Banyan, the test is expected to cost about $150.

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