A year after it came into being, the market for coronavirus diagnostics is dramatically evolving with the focus of growth inevitably shifting to products designed for serial screening of the asymptomatic at home and at the point of care. On March 16, the FDA took measures to accelerate this change in direction by issuing guidance to help developers of asymptomatic screening tests bring their products to market quickly and more easily. Here’s a rundown of the new guidance “Supplemental Template for Developers of Molecular and Antigen Diagnostic COVID-19 Tests for Screening with Serial Testing” and what it portends for the future of COVID-19 diagnostics. COVID-19 Testing 2.0 Notwithstanding the slight uptick of early March, COVID-19 case, hospitalization and death rates across the U.S. are falling and, knock on wood, will keep on declining in the coming months. Even so, COVID-19 isn’t likely to disappear, and as long as the virus remains a menace, people will need to get tested for SARS-CoV-2. However, test demand and utilization patterns will change. As cases fall, the emphasis will shift from testing the symptomatic for purposes of diagnosis and treatment to widespread screening of people in congregate settings regardless of whether they have symptoms. […]