FDA Approves First Blood Test For Concussions

FDA Approves First Blood Test For Concussions

According to the FDA, many patients who suffer a concussion, also known as mild traumatic brain injury, don't have any detected intracranial brain lesions, which makes a CT scan uncessary. The proteins begin to spike as soon as 15 minutes after the injury occurs, and the blood test can still detect the lingering markers of a concussion as long as 12 hours after the fact. Banyan applied its test to nearly 2,000 blood samples taken from patients with suspected concussion and compared the results to CT scans. The method of taking blood tests to diagnose brain injury was discovered some years ago but just yesterday the FDA approved it.

FDA commissioner, Gottlieb added that, "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".

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A study of almost 2,000 individual blood samples saw the Brain Trauma Indicator accurately predict the presence of intracranial lesions on CT scan 97.5 percent of the time, while correctly predicting the absence of said lesions 99.6 percent of the time.

Now computed tomography (CT) scan is used routinely in the evaluation of TBI, however, a majority of patients evaluated for mTBI do not have detectable intracranial lesions after having the scan. "We are honored to have as our partner, the U.S. Department of Defense and the U.S. Army Medical Research and Materiel Command, for supporting the research and development of a diagnostic test that now provides objective quantifiable information to physicians, to eliminate unnecessary CT scans, and guide patient care".

Blood Test for Concussion OK'd

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.

The FDA approved the test as part of its breakthrough devices program after evaluating a clinical study of 1,900 blood samples from people thought to have concussion or mild traumatic brain injury. This exposes patients to radiation and drives up healthcare costs.

Other companies are developing similar blood tests to detect brain injuries.

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.

Quanterix is also working to develop a blood test to diagnose concussions and other brain injuries.