As first OTC COVID-19 test raises stakes for consumer guidance, Abbott opts for prescription path

FDA’s first authorization of an over-the-counter, at-home COVID-19 antigen test marks a major step in the intersection of individual self-monitoring and public health, and ups the ante on communicating uncertainty around results.  Abbott’s home test, authorized Wednesday, brings a narrower indication but higher volume.

Brisbane-based Ellume Ltd., which submitted an application for emergency use authorization (EUA) on Nov. 9, received authorization for its COVID-19 antigen test Tuesday. ...