At-home and point-of-care (POC) serial testing for purposes of screening the asymptomatic is, arguably, the most promising, long-term market for new SARS-CoV-2 diagnostics. On March 16, 2021, the U.S. Food and Drug Administration (FDA) issued new guidance to help developers of these tests bring their products to market faster. Here is a rundown of the new “Supplemental Template for Developers of Molecular and Antigen Diagnostic COVID-19 Tests for Screening with Serial Testing” (Template) and what it portends for the laboratory test development business. The Diagnostic Challenge Notwithstanding the slight uptick in early March, COVID-19 case, hospitalization and death rates across the U.S. are falling and, knock on wood, will continue to do so in the coming months. Regrettably, though, COVID-19 is not going away; nor is the need for SARS-CoV-2 testing. However, what will change are testing demands and utilization patterns. As the virus retreats, the emphasis is bound to shift from testing the symptomatic for the purposes of providing medical treatment to testing the asymptomatic for screening. Of course, these products will have to get past the FDA goalie and secure Emergency Use Authorization (EUA) to reach the market. And therein lies the problem. Previously, all of the templates […]