Hope for Biomarkers to Diagnose Brain Injuries
Research on the use of blood biomarkers for diagnosing brain injuries — in theater and in the civilian world — is getting closer. The hope is to be able to use it as a standard diagnostic tool.
So where are we with regards to biomarker research and actually potentially getting a biomarker diagnostic platform, not only in theater but available to the civilian community. So where are we? Well, we're actually quite advanced at this point in time. I mean, this research has been going on. I like to believe that my group and the group at the University of Florida are really the first to conceive of this concept that-- just like the troponin enzyme test for heart failure, which is the standard of care diagnostic-- that we can do the same thing with brain injury. We went through several years of animal research to generate the type of data that we thought was going to be needed to convince the Army that we're on the right track and that we can make this happen. I'm not a molecular biologist, but I learned very quickly that we had some very significant challenges particularly on what they call the assays-- the test platforms to identify whether a molecule--a material that's in the brain-- has changed enough. The Army helped support a human studies trial in moderate and severe brain injuries, and we had over a course of 2-1/2 years, we completed a 200-patient study demonstrating very convincingly that there are certain biomarkers that will change. There are certain proteins that will change in the brain and only in the brain when the brain is hurt. Of course it is much easier to see that in a very severe TBI, but it gives you the--what's called proof of concept data. And with additional money from the Department of Defense and Congressional add-ons that came about because of the TBI problem, we were able to complete a preliminary study in 80-some concussion patients again with very promising results, and this is real--this is hard-core research. The severe data has been published in peer-review journals, and the data from the pivotal--no, from the preliminary study is being examined now by reviewers to be published in research journals. And as a result of that, the Army is funding a major pivotal trial to generate enough data on a specific device platform to then take that to the FDA for approval. One thing about the military-- military medicine--our regulations are that no therapy, no treatment, no diagnostic platform will go into theater and be introduced into our soldiers without FDA approval. So that's the yardstick that we must meet even though we're the military. People seem to think you can do whatever you want. No, not at all.
Posted on BrainLine May 21, 2012.
Frank Tortella, ST, PhD serves as the U.S. Army’s Medical Research and Material Command’s subject matter expert on neurotrauma and neuroprotection research for a diverse range of insults to include traumatic brain injury, concussions, and the neurological effects of blast exposure.
Produced by Brian King and Noel Gunther, BrainLine.