Which types of innovation, adaptation, and acceleration happened in diagnostic technology companies in the face of the COVID-19 pandemic? And are the intensity and the fast-moving strategies that were necessary even sustainable?
These were some of the themes addressed during a panel discussion that was part of a Silicon Slopes virtual event held on Thursday, January 7, to examine Utah’s response to COVID-19. Keith Marmer, MBA, of the University of Utah’s PIVOT Center, moderated the panel, which included Adam Barker, PhD, director of the ARUP Institute for Clinical & Experimental Pathology; Robert Glanzman, MD, chief medical officer of Clene Nanomedicine; and James McCullough, CEO of RenalytixAI.
Barker pointed out that in nine months, ARUP went from performing zero COVID-19 tests to performing more than a million COVID-19 tests. “This is a huge feat for a lab this size in a nine-month time span. In an average year, we will do 10,000 to 15,000 flu tests a season; compare that to 1.4 million COVID tests.”
“The acceleration of innovation has been absolutely stunning, and it has shown us what is possible. The diagnostic landscape has inexorably changed.”
CEO of RenalytixAI
To meet the demands for testing, ARUP opened new COVID-19 testing labs, hired more than 300 people within four months, and, when supply shortages hit, started building its own specimen collection kits to distribute to clients. ARUP now makes 50,000 collection kits a day.
The pandemic accelerated the research and development of antibody tests as well. McCullough’s company teamed up with Mount Sinai researchers to develop and scale up production of a COVID-19 antibody test that has now launched in Europe and has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). McCullough explained that antibody tests and research could help with vaccination rollout; those who test positive for antibodies against SARS-CoV-2 could perhaps hold off on getting vaccinated.
“The acceleration of innovation has been absolutely stunning, and it has shown us what is possible,” McCullough said. “The diagnostic landscape has inexorably changed [due to the pandemic].”
The pandemic has challenged the regulatory landscape as the FDA hustled to safely get tests and therapeutics into clinical environments. The pendulum has swung from long, rigorous approval processes to expedited ones in the form of EUAs. “This has been an amazing time for the FDA,” Barker said. “I think it has shown all of us [FDA included] that things can go faster but that not everything should get through fast. I see a happy middle ground coming regarding regulations and the FDA.”
“The COVID-19 state of mind is percolating in other FDA divisions,” added Glanzman, of Clene Nanomedicine. “There are new attitudes [as a result of the pandemic] that can move into the future.”
Are the Pace and Level of Innovation Sustainable?
The pandemic has brought medical minds, ideas, and solution seekers together—across companies, industries, and the world—unlike anything else before. “This has really shined a light on the way things can be done,” said McCullough, who first anticipated that productivity would go down as people hunkered down and worked remotely. The opposite happened. “The intensity and productivity of the work has accelerated. It has shown us what is possible.” RenalytixAI has hired 30 people in the past few months—many of whom McCullough has yet to meet in person.
At ARUP, which operates around the clock, seven days a week, Barker wonders if the pace set this year is sustainable. “I don’t know if we can sustain it. But when I speak to my R&D staff, I tell them that this is a once-in-a-lifetime opportunity to do cutting-edge work in diagnostics to save people’s lives.”
To watch the Silicon Slopes recording of this event, visit this Silicon Slopes YouTube page.