Doctors at a U.S. Army base say they’ve made a medical breakthrough: a simple blood test that can detect mild traumatic brain injury (TBI). If the test proves reliably predictive—and if it is accepted by the medical community—it would be the first objective test to diagnose TBI.
In October, a team of researchers at the Combat Casualty Care Research Program (CCCRP), located at Fort Detrick, Maryland, issued a statement describing a study they had performed on 34 patients with concussions. The study found that the blood test could detect small amounts of unique proteins that leak into the blood when brain cells are damaged. The test is similar to those that detect specific proteins to diagnose heart disease in its early stages.
The Department of Defense has awarded a multimillion-dollar contract to Banyan Biomarkers, a biotech company based in Alachua, Florida, to conduct a larger clinical trial of 1,200 patients that is expected to end in 2013. The Army and Banyan have applied for FDA approval of the test, which will likely hinge on the results of that trial.
According to the Centers for Disease Control and Prevention, about 1.7 million Americans suffer a traumatic brain injury each year, and most of these are classified as “mild.” Brain injury is known as the “signature wound” of soldiers who serve in Iraq because of their frequent exposure to explosions. The Defense and Veterans Brain Injury Center has found that since 2003, 30 percent of soldiers admitted to Walter Reed Army Medical Center in Washington, D.C., suffered from TBI.
Dallas Hack, an Army colonel and director of the CCCRP, told USA Today that the new blood test was “going to change medicine entirely.”
A simple biomarker that could detect TBI would be a major medical and legal development—the condition is notoriously difficult to diagnose and, for litigators, to prove in court. TBI is known as the “invisible injury” because it is rarely seen in objective tests.
But some attorneys have urged caution about a test that has been used in only a small sample of patients and has not yet been granted FDA approval.
“Is the Army really onto something?” said Stewart Casper, a lawyer in Stamford, Connecticut, and chair of AAJ’s Traumatic Brain Injury Litigation Group. “It’s hard to say at this early stage. There is a lot happening in the field of TBI—even the classification of TBI is changing, and it may take years to reach a consensus.”
Casper said that the past few years have seen dramatic advances in neuroimaging, which have made the diagnosis of TBI more accurate. A biomarker, if it proved reliable, would be the “gold standard,” but that does not mean other methods are unreliable, he said.
“We now know that with the sophisticated neuroimaging—especially with MRIs—that are available now, we can diagnose brain damage in ways we couldn’t when neuroimaging was first introduced,” he said.
Kenneth Goldblatt of Mohegan Lake, New York, chair-elect of the litigation group, also expressed a reserved optimism.
“This test—if it is accurate, validated, and accepted by the medical community—could be an important diagnostic tool for medicine, and a better evidentiary tool for us,” he said. “Certainly it will make it easier to show TBI to a jury.”
He pointed out, however, that insurance companies will fight the introduction and use of any new test, no matter how reliable.
“Thirty years ago, they were calling MRIs unreliable and hogwash,” he said. “Now they’re standard. This is their standard response to any medical advance, and I predict it will be the same to this one.”