Pharmaceutical

FDA approves blood test to help doctors evaluate concussions

skull xray FDA approves blood test to help doctors evaluate concussionsA new blood test that evaluates mild traumatic brain injury (mTBI) in adults has been approved by the Food and Drug Administration (FDA).

The Brain Trauma Indicator, made by Banyan Biomarkers Inc., helps medical professionals determine whether patients with a suspected mTBI need a CT scan for further evaluation. The test is designed to prevent unnecessary neuroimaging and associated radiation exposure to patients.

Most patients with a suspected head injury are examined using a neurological scale, the 15-point Glasgow Coma Scale, followed by a CT scan of the head to detect brain tissue damage or intracranial lesions that may require treatment. However, a majority of patients evaluated for mTBI do not have detectable intracranial lesions after having the CT scan.

The Brain Trauma Indicator measures levels of proteins, known as UCH-L1 and GFAP, that are released from the brain into the blood and measured within 12 hours of head injury. Levels of these blood proteins after mTBI can help predict which patients may have intracranial lesions that would be visible by CT scan, and which won’t. Test results are available within three to four hours.

The FDA approved the test based on a multi-center, prospective clinical study of 1,947 individual blood samples from adults with suspected mTBI or concussion, and reviewed the test’s performance by comparing the mTBI/concussion blood test results with CT scan results. The Brain Trauma Indicator was able to predict the presence of intracranial lesions on a CT scan 97.5 percent of the time, indicating that the test can reliably predict the absence of intracranial lesions, and that health care professionals can incorporate this tool into the standard of care for patients to rule out the need for a CT scan in at least one-third of patients who are suspected of having mTBI.

Source: FDA News Release