Eric Konnick, MD, MS, FCAP, Engaged Leadership Network Member, discusses how the COVID-19 pandemic raised questions about how prepared the FDA is to tackle LDT regulation. "If you look at just genetic testing … there were about 75,000 genetic tests on the market as of 2018," said Dr. Konnick. "Assume most of those are at least moderate risk and would have to be reviewed. Look at COVID – it took two years to get through 3,200 relatively simple applications. It's really challenging to imagine how this would function."
For the full article click here: Lab Stakeholders Question if FDA has Resources to Implement LDT Oversight Plans