CGI’s co-founder and CEO, Dr. Julie Eggington, was a winner of a 2019 Sego Award in Innovation in Technology as a leader in Utah’s business community, a unique accomplishment for the leader of a nonprofit organization. She was recently interviewed by Salt Lake City’s Department of Economic Development about founding the Center for Genomic Interpretation in Utah, and about the business of healthcare nationwide:
“The so-called hype cycle tends to drive many investor decisions and pressures in healthcare innovation. And while leveraging the hype cycle is a great marketing tool for diagnostic companies, it often results in unsafe healthcare for patients and poor returns for investors. When a new technology emerges, investors jump on board. Then all the VC money comes. Many diagnostic companies form and they promise the moon to their investors. In genetic and genomic diagnostics, most companies reduce go-to-market time and costs by using the Laboratory Developed Test regulatory loophole, which allows these companies to avoid having to demonstrate safety and efficacy of their clinical diagnostic tests. This regulatory loophole is how Elizabeth Holmes perpetuated the now famous Theranos diagnostic scandal. The negative impact that Theranos’ activities had on patients is only the tip of the iceberg when it comes to the numbers of patients being impacted by unvetted medical diagnostics across the USA, particularly in genetics and genomics. Some companies do a great job of vetting their genetic diagnostics, but most don’t since it’s not required.
Precision medicine is now at the beginning steep climb of the hype cycle where there’s lots and lots of over-promising happening. Most technology hype cycles take years to peak then deflate to a level where reality wins and the technology is ultimately used in mostly effective ways.
The problem with hype cycles in medicine, particularly when paired with a regulatory environment that doesn’t require proof of clinical efficacy or patient safety, is that patients get harmed in the intervening years while the hype cycle runs its course. Right now, new technology’s ability to give readouts in biology far exceeds our ability to understand the clinical meaning of most of the readouts….
At the nonprofit I run, we work daily to encourage a national landscape where health insurance companies won’t reimburse for diagnostics unless the diagnostics have proven clinical efficacy and patient safety. Clinical efficacy, not hype, is what deserves attention.”
Read the full article and interview here.
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