Military leaders, athletic coaches and the general public are beginning to have a better understanding of concussions, also called mild traumatic brain injuries, and their long-term effects if left untreated. Thanks to a public-private partnership led by the U.S. Army, there is now a blood test to detect these often invisible or easily hidden injuries.
The Food and Drug Administration in 2018 approved the first diagnostic blood test for concussions, a significant breakthrough that will provide quick and accurate detection of mild traumatic brain injury among members of the military hurt on the battlefield. It could also be used to assess athletes injured during sporting events and individuals hurt in motor vehicle accidents or falls.
This game-changing blood test was developed, tested and successfully taken through the FDA approval process by an interdisciplinary team currently led by Dr. Krista Caudle from the U.S. Army Medical Materiel Development Activity at Ft. Detrick, Maryland, in cooperation with Banyan Biomarkers Inc., a diagnostic products company. Development of a blood test for concussions has been a goal of the Department of Defense for more than a decade.
“There are blood tests for many diseases on the market, but this is the first one dedicated to traumatic brain injury,” said Army Lt. Col. Kara Schmid, who has helped oversee the project. “For the first time, medical personnel won’t have to rely only on a description of the incident and symptoms but will have access to an objective marker of injury to the brain, all from a simple blood test.”
Caudle took over management of the blood test development and approval process in 2016 after clinical trials had been completed, and a sense of urgency was needed to finalize the assay. Through her effective leadership, Caudle brought all the parties together on the process, protocol and standards for the test, and to obtain FDA approval and prepare for eventual medical use.
“This project was complicated from a technical standpoint, a regulatory standpoint and a contracting standpoint, and there were so many stakeholders involved,” said Kathleen Berst, the Defense Health Agency program manager for pharmaceutical devices and medical support systems.
“Krista did a great job working with all of the different stakeholders and bringing them together to focus on the same goal,” Berst said. “She showed up with ideas and solutions and not with a list of problems. She is an amazing team builder.”
The Defense and Veterans Brain Injury Center estimates that more than 375,000 service members have been diagnosed with traumatic brain injury since 2000, with about 82% of these cases classified as concussions. In the civilian world, the Centers for Disease Control and Prevention estimated there were about 2.5 million emergency room visits and 282,000 hospitalizations in 2013 as a result of traumatic brain injury. And each year, it is estimated, there are about 300,000 sports-related concussions.
Historically, the evaluation for concussions has been a subjective assessment of both the incident and symptoms, but there has been no objective measure. Patients are often unnecessarily given CT scans that turn out to show no lesions in their brains, or they might return to the battlefield despite having an injury that can worsen without rest and recovery.
The new test reveals the presence of specific proteins in the blood after a head injury that disrupt brain function. It allows for detection and, if the blood test proves negative, it will save health care costs and spare patients unnecessary exposure to radiation from CT scans.
Marketed by Banyan Biomarkers, the test can be used within 12 hours of injury to determine if a patient requires a CT scan, and delivers results within four hours. Caudle’s team now is working with global health care company Abbott Laboratories to develop a handheld, blood testing device that will use only a few drops of blood and provide results of possible brain injury within 15 minutes. This will permit widespread and easy use for both military and civilian purposes.
“We want to give our providers—our physicians, our nurses, our physician’s assistants—the most technologically advanced products so that we can help wounded heroes on the battlefield,” said Dr. C. Hank Gardiner, head of the Army team in charge of determining requirements for users of the blood test. “This also is going to make as big a difference to our civilian population. This is revolutionary.”
Army Col. John Ryan Bailey said Caudle had to navigate the many complexities involved in the process, from seeking regulatory approval to working with the companies that will market the test and develop a portable device for its use.
“There was no template to say, ‘This is how you do it.’ She had to pave the way for this product,” Bailey said. “Her work highlights a textbook way we like to do business, where we can make something that’s needed in the military but has applicability in broader society.”
Caudle said laying the groundwork for a brand-new medical product has been “an uphill climb” with many challenges, but she added that the ultimate goal has been to improve medical care for members of the military.
“Keeping the service members at the front of our minds was my way of motivating our team, and that really accelerated our work,” Caudle said. “That helped get everyone focused and pulling in the same direction.”