Blood Test for Concussion OK'd

Blood Test for Concussion OK'd

FDA approves first blood test to help diagnose concussions

"Today's action supports the FDA's Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging - an effort to ensure that each patient is getting the right imaging exam, at the right time, with the right radiation dose", Scott Gottlieb, MD, commissioner of the FDA, said in the release. Use of the blood tests could begin as soon as this year.

The new test measures levels of certain proteins that are released from the brain into the blood within 12 hours of a head injury.

According to the US Centers for Disease Control and Prevention, there were approximately 2.8 million incidents involving traumatic brain injury emergency department visits, hospitalizations and deaths in 2013.

The FDA believes that using the new blood test, imaging can be avoided in at least a third of patients who are suspected of having a concussion.

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For the moment, it is expected to be available in Emergency Rooms in the USA hospitals this year but it will be double-checked by a CT scan.

A blood test for mild TBI/concussion will likely reduce the number of CT scans performed on patients with concussion each year. Banyan says that measuring the levels of the two brain proteins can help clinicians determine whether or not to proceed with a CT scan. Test results can be available within three to four hours. It's created to help doctors quickly determine which patients with suspected concussions may have brain bleeding or other brain injury.

The Food and Drug Administration on Wednesday approved a first-ever blood test to detect the telltale signs of serious brain injury, bringing to fruition a long quest to make the diagnosis of concussions simpler and more precise.

Trial data involving almost 2,000 individuals with with suspected concussion or mild traumatic brain injury (mTBI) showed that the test was 97.5% accurate in identifying those with visible lesions on CT scans, and 99.6% accurate in predicting those who did not show such lesions. And that's where Banyan's blood test can help. CT scans are special X-ray tests that cost money and expose patients to radiation. In a multicenter clinical study, the blood test was able to predict the presence of intracranial lesions on a CT scan 97.5% of the time and identified those who did not have intracranial lesions on a CT scan 99.6% of the time. That limitation in research data dictated the FDA's approval of the blood test's marketing to adults. "But we are planning to do another study in adolescents", he added.

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