The FDA is following a two-prong strategy to promote and expedite development and validation of a test capable of safe, rapid and reliable detection of novel coronavirus (COVID-19), the disease caused by the SARS-CoV-2 virus. Here’s an overview of the progress being made—and not made—on both fronts. The Traditional EUA Pathway The FDA is calling on test makers to seek rapid approval via the emergency use authorization (EUA) pathway the way it did with SARS, H1N1 and other previous outbreaks. The problem is that novel coronavirus isn’t a known pathogen the way the previous outbreak viruses were. As a result, the diagnostics have to be created from scratch. The other issue is time. Historically, it takes months to secure EUA clearance. The good news is that the FDA has streamlined its application process by implementing a rolling process using an electronic template. The agency reports that it has already contacted more than 70 test makers interested in seeking EUA for coronavirus detection tests. In fact, the agency has already broken its own speed record by issuing its first EUA on February 4, less than a week after mobilizing the pathway, for a reverse transcriptase real-time PCR (rRT-PCR) assay (aka, the […]