In developing a new diagnostic test, which comes first, the technology or the clinical need? Over the years, clinical laboratorians have witnessed the emergence of and improvements in a staggering number of new diagnostic tests, with the exponential growth of technology seeming to drive this growth. But there may be a problem with always putting technology first. It may not be the best approach when designing a diagnostic test that truly improves patients’ health. What if instead, clinical need was the driver for new innovation? How would that dynamic shift the development of new diagnostic testing and subsequent improvement in patient care and public health?
David Walt, PhD, in his plenary talk “Biomarker Discovery: From Technology Development to Clinical Applications” on Sunday afternoon helped to answer those questions. Walt is considered an innovation pioneer and was inducted into the National Inventors Hall of Fame this year. Specifically, he is being recognized for his work in the development of “microwell arrays” that transformed the field of genetic testing. This explosion in genetic testing has forged a new frontier of clinical research and development to identify and treat human disease.
In this presentation, Walt described how currently, the biomarker discovery process tends to emphasize technology before clinical application. He argued that this paradigm may not be effective at providing new clinically relevant and useful diagnostic tests, and explained that innovation does not necessarily guarantee improvement in the clinical workup of a patient. “Many technology developers do not fully understand the clinical application and select biomarkers that are inappropriate for the particular disease,” he noted.
This lack of understanding may be leading researchers to develop thousands of diagnostic tests that have dubious clinical utility. “One needs to start with an unmet clinical need” if we are to make clinical laboratory tests that actually aid in improving patient care, he said.
Walt dove into the current timeline of a new clinical test, from conception to application. He described the process of bringing a new diagnostic test to market as taking far too long in our current system to be effective. He went on to explore the ways in which we can successfully compress this timeline. “We need to completely change the way we commercialize new technologies” in order to decrease the time needed to translate a basic research innovation into a functional and useful laboratory test, he said.
Walt’s vision of a future where clinical need comes first is a fundamental perspective. It reminds us why our field is so important. As experts in clinical laboratory testing, we must integrate ourselves further in the diagnostic testing development space. Only then can we continue the mission of providing vital insight and guidance so patients get the care they need.