Friday, May 22, 2020

DiagNo!

The United States Food and Drug Adminstration ("FDA") has listed almost 30 SARS-CoV-2 antibody-detection products as unapproved for sale.  This reflects the challenges of developing, and obtaining licensure for, such diagnostic tests.  The crowd of products ordered off the market also illustrates how great the market opportunity for such tests is perceived to be.