By Lisa DeRuiter - WUFT Contributor
Sports teams may no longer have to rely on an athlete’s word to diagnose a concussion, thanks to a new traumatic brain injury test.
Banyan Biomarkers is conducting research at the University of Florida on its new test, which detects and measures the severity of traumatic brain injuries, or TBIs, through blood samples.
“The test will be one of the biggest breakthroughs in traumatic brain injuries ever,” said Jackson Streeter, CEO of Banyan Biomarkers. “Right now, there is no way to quantify TBIs. It’s often called the invisible injury.”
For the test, researchers take a blood sample and search for specific biomarkers, proteins from neurons and other cells that are not normally present in the blood.
“These proteins should not be present,” Streeter said. “They’re supposed to be in your brain. They’re not supposed to be in the blood. After you’ve had an injury, these proteins will cross the blood-brain barrier and be detectable in a serum.”
The traumatic brain injury test is the first blood-based one in existence and also allows medical professionals to measure the extent of the injury. The number of biomarkers found in the blood correlate to the severity of the injury with higher numbers corresponding to more serious injuries.
Jay Clugston is a team physician for UF football and the research coordinator for the Gator Study, which involves examination of the test on sports concussions at UF. He reached out to Streeter and his team after hearing about the work the company was doing with brain injuries.
“Most tests require a person to answer truthfully without bias or without trying to lie to get back into a game or for a physician to say whether or not the person has a concussion,” Clugston said.
This can be a problem. Some concussions are obvious and can be easily diagnosed due to the nature of the hit or the response of the athlete, but others aren’t so clear.
Many of the current diagnostic methods involve a baseline test performed before the season. The same test is then repeated after an injury, and the results are compared.
“Those can all be kind of faked or manipulated,” Clugston said. “We have athletes that are savvy enough that they’ll maybe purposely score low on a baseline test knowing that that will allow them to get back to play faster.”
He said researchers have been looking for a more objective way to diagnose concussions.
The Gator Study is specifically looking at sports concussions. The tests are being performed on UF football, soccer and lacrosse players, and the athletes’ participation is voluntary.
For the study, researchers perform a baseline blood test before the season. Within one hour of an injury occurring, a blood sample is taken by sticking the player’s finger. A venous sample is then taken from an elbow or forearm within four hours of the injury.
Gator Study researchers have been collecting data for two and a half years, but the results have not been analyzed yet. They plan to do so in the next six months, and the test has the potential to be an objective way to diagnose sports concussions.
UF is also one of more than 20 centers around the world where Banyan Biomarkers is conducting its Alert TBI trial. This is the final, pivotal stage of testing where the company is experimenting on 2,000 patients to become approved by the Food and Drug Administration. Along with the Gator Study, Banyan Biomarkers is using the Alert TBI trial to complete its research.
Banyan Biomarkers asked Latha Ganti, who is the principal investigator for the trial and the director of the Center for Brain Injury Research and Education at UF, to help in the Alert TBI trial.
“As the director for CBIRE, I made a commitment to improving the care of patients with head injuries,” Ganti wrote in an email. “Unfortunately, not a lot is known about how to best manage a TBI despite its growing prevalence.”
Currently, if doctors are worried about a brain injury, they have a CT scan done. It can detect structural abnormalities but is limited in finding neurometabolic changes, which are thought to cause many traumatic brain injury conditions. Therefore, a CT scan can come out normal even when a patient is injured.
The team plans to enroll 200 patients in the study and has currently registered 75.
Streeter, CEO of Banyan Biomarkers, said the Alert TBI trial stage will be complete early next year, and the company hopes to get the test approved by late 2014. The next step will likely be to partner with other larger companies to help distribute the test throughout the world.
Banyan Biomarkers, which Streeter described as “Gator-grown,” was originally founded in 2002 by three scientists out of the McKnight Brain Institute at UF who were working with traumatic brain injuries at the time.
“All the preliminary research was done at UF, and it showed promise to commercialize it,” Streeter said.
Banyan Biomarkers also has other projects but is mainly devoted to brain injuries. It has collaborated with and received the majority of its funding from the U.S. Department of Defense.
“This will be a big breakthrough in the field of brain injuries, and it will have all come out of the University of Florida,” Streeter said. “That’s pretty exciting for us and the university.”