Biomarkers for TBI: Still Moving from Bench to Bedside
Getting an effective blood biomarker test for TBI from bench to bedside with FDA-approval along the way is no small feat. Dr. Ronald Hayes talks about two proteins for which researchers have high hopes.
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The 2 that we're focusing on are glial fibrillary acidic protein, which of course is ubiquitin carboxyl-terminal hydrolase, the L1 isomer, which is a very geeky way of saying-- we call them GFAP and UCHL1. GFAP is found almost exclusively virtually in the brain alone and in the cells we call glia, which don't transmit electrical impulses but they provide a lot of supportive-- they're the infrastructure that supports the life and function of brain cells, the neurons. And the neurons, of course, conduct the information, relevant entities of the brain, cells of the brain, and they contain UCHL1. We have 1 marker that reflects damage to glia and another to neurons. Those are our lead markers. Now, we have other markers that could look at damage in glia or to myelin that surrounds axons or to axons. And those remain very interesting research projects, and a good bit of work is going on. But to move a biomarker from a research standpoint to an FDA-approved biomarker that a physician can make a clinical decision on requires a huge amount of non-scientific and regulatory work, including assay development, for example. How do you get this assay optimized and put on a device, a medical device like a bench top reference lab high throughput system or what we call a point of care assay? It's hugely expensive and time consuming. Industry figures are that it costs $100 million or more to bring a biomarker to FDA approval. We'll do it far cheaply that that, and there are no FDA-approved biomarkers for brain injury. You've got to place your bets. Our bets are currently on these 2 markers. We have others in the pipeline.
Posted on BrainLine April 2, 2013.
Ronald Hayes, PhD is a co-founder and president of Banyan Biomarkers, Inc. He is director of Banyan’s Clinical Programs and Banyan Laboratories.
Produced by Brian King, Vicky Youcha, and Erica Queen, BrainLine.