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.
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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.
Produced by Brian King and Noel Gunther, BrainLine.
Frank C. Tortella, ST, PhD, serves as the U.S. Army’s Medical Research and Materiel 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.
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