Embedded in a feature story on diagnostic microchips, Texas CEO magazine makes a compelling case for the reasons behind biomarkers' seeming inability to transfer quickly enough from lab to clinic. The authors take the view that there is not something intrinsically wrong with the science, as some say, rather something wrong in the approval process and lack of standards.
First, the magazine lays out the problem: More than 20,000 cancer and 6,000 cardiac biomarkers have been published in the last 15 years, yet only 1.5 protein biomarkers per year are approved by the FDA. "Unless FDA approval is secured, biomarkers will remain academic curiosities and will not enter widespread clinical practice," say the authors, who are micro- and nanotech experts at Rice University in Houston.
"These statistics are sobering, but they also point to tremendous opportunities for new technologies that will greatly enhance bench-to-bedside translation," they continue. "While the biomarker-derived information content is abundant, lacking now are the tools and the standards to retrieve this information in clinically relevant settings along with efficient multi-marker approval strategies."
Their solution: the marriage of microdevices with microfabrication, designed and developed by bioengineers and steered by clinicians, will create tools that can "talk to the biomarkers." This revolution in hardware will complete the "transformative changes in health care" made possible by biomarkers.
- read the whole article in Texas CEO