FDA Clears First Blood Test to Diagnose Concussions

February 15, 2018

The FDA on Wednesday cleared the sale of the first blood test to evaluate concussion in adults. The agency said a blood test could help avoid unnecessary computed tomography scans of the head, because most patients evaluated for concussion do not have detectable intracranial lesions.

The FDA on Wednesday cleared the sale of the first blood test to evaluate concussion in adults. The agency said a blood test could help avoid unnecessary computed tomography (CT) scans of the head, because most patients evaluated for concussion do not have detectable intracranial lesions.

The approval was granted to Banyan Biomarkers, Inc. The test, called the Brain Trauma Indicator, was approved in fewer than 6 months as part of the FDA’s breakthrough devices program.

The test works by measuring levels of proteins, known as UCH-L1 and GFAP, that are released from the brain into blood and measured within 12 hours of head injury. Levels of these blood proteins after concussion can help predict which patients may have intracranial lesions visible by CT scan and which will not. Being able to predict whether patients have a low probability of intracranial lesions can help healthcare professionals manage patients and decide whether or not to perform a CT scan. Test results can be available within 3 to 4 hours.

Avoiding scans when possible will cut unnecessary radiation exposure as well as the cost of the scans, the FDA said in a statement.

“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,” said FDA Commissioner Scott Gottlieb, MD.

According to the CDC, in 2013, there were approximately 2.8 million emergency department visits, hospitalizations, and deaths related to concussions. Of these cases, concussion-related head injuries contributed to the deaths of nearly 50,000 patients.

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. These findings indicate that the test can reliably predict the absence of intracranial lesions.

According to the Choosing Wisely campaign from the ABIM Foundation, brain scans are usually not useful for diagnosing concussions. Choosing Wisely aims to encourage conversations between clinicians and patients by educating patients about care that is supported by evidence, not duplicative, free from harm, and necessary.