FDA Approves Marketing Of First Blood Test To Diagnose Concussions


The U.S. Food and Drug Administration has authorized the marketing of a blood test that can help diagnose concussions more quickly and without the need for X-rays.

Test To Save Money And Reduce Radiation Exposure

In a statement released on Wednesday, Feb. 14, the FDA said that this test could save money and even reduce a patient's exposure to radiation.

The test can help doctors identify which patients would require computed tomography (CT) scan to check if they have brain damage. CT scans are special X-ray tests that cost money and expose patients to radiation.

"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 tests," said FDA Commissioner Scott Gottlieb.

Banyan Brain Trauma Indicator

The Banyan Brain Trauma Indicator will show markers that indicate a person really needs a CT scan, which means that it will precede a CT scan unless the person shows signs of extreme trauma.

Cleveland Clinic Concussion Center director Jay Alberts said that the blood test will be most useful in assessing mild head injuries when it isn't clear if someone has concussion.

Alberts also said that the test will not replace CT scan all the time. He explained that the scans are being done to identify important brain injury that requires surgery.

Doctors may still recommend that a patient undergoes a CT scan or MRI if there are major changes in the person's function following a head injury. Nonetheless, 99 percent of concussions do not require a CT scan because these are not clinically important and thus do not need immediate surgery.

How It Works

The blood test measures levels of proteins UCH-L1 and GFAP that are released from the brain into blood and measured within 12 hours after the head injury happened.

Levels of these blood proteins can help predict if a patient has probability of having intracranial lesions, which can help health care professionals determine how to manage their patients' conditions.

"Banyan BTI has shown that these two specific protein biomarkers, which are released from the brain and circulate in the blood after a brain injury, can provide objective data to healthcare providers when evaluating patients with a traumatic brain injury," said Banyan Biomarkers CEO Henry Nordhoff.

The results will be available within three to four hours. San Diego-based Banyan Biomarkers, which obtained the permission to market the blood test, is also currently working with the Defense Department to shorten the turnaround time to under one hour.

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