Currently, physicians rely on subjective markers like headaches, nausea and light sensitivity to determine if there is bleeding or bruising in the brain. They made an educated guess on who has brain trauma and needs a head CT scan. The new blood test, however, can give an objective indicator of injury that can be received quickly and easily in busy emergency departments.
The FDA approved the test early this year as part of a fast track program that allows breakthrough technologies to get to patients quicker. The test, known as the Banyan Brain Trauma Indicator, helps evaluate patients with a suspected traumatic brain injury or concussion. It went though a clinical trial that had close to 2,000 patients with a head injury in 22 emergency departments in the U.S. and Europe. Banyan Biomarkers, the company that developed the test, is not working with commercial partners to bring the blood test to hospitals and emergency departments.
“Many concussion patients don’t seek medical care for their injury, a decision due in part to the perception that emergency departments have nothing to offer in terms of diagnosis,” Jeffrey J. Bazarian, the study’s lead author, said in a press release. “The results of this study show that we now have something to offer–a brain biomarker blood test. The ability of this test to predict traumatic injuries on head CT scan will soon allow emergency physicians to provide patients with an unbiased report on the status of their brain.”
The researchers suggest that the Banyan Brain Trauma Indicator could be valuable for emergency room physicians while reassuring concerned patients and families.
The test works by detecting two brain proteins that are typically present in the blood after someone revived a hit to the head. The study showed that if the test was negative, it was unlikely that there was traumatic intracranial injury present and that a CT scan was unneeded. When the test was positive, that was an indicator that a brain injury could be present and the patient should have a head CT scan done for further assessment.
In a clinical trial, the Banyan Brain Trauma Indicator test was positive in 97.6% of patients who had a traumatic intracranial injury on a head CT scan. The test also showed that the probability of a patient with a negative test result who had a normal CT scan was 99.6%.
The blood test works up to 12 hours after an injury and detects the presence of the brain proteins UCH-L1 and GFAP. The researchers say that these biomarkers are only elevated when someone is hit in the head and not other body parts like the shoulder or abdomen.
Banyan Brain Trauma Indicator blood tests are approved to be used in patients who are 18 years or older. The researchers suggest that it has the chance to reduce CT scans and radiation exposure. CT scans are commonly used to diagnose brain injuries, but less than 10% of head CTs show injury, according to the researchers. Using the blood tests could eliminate the need to use CT scans and allow people to get out of the emergency room quicker.
The research was published in The Lancet Neurology journal and was funded by Banyan Biomarkers and the U.S. Army medical Research and Material Command.