Michael Mina, a “MD, PhD, Assistant Professor of Epidemiology and Immunology, Harvard T.H. Chan School of Public Health, Center for Communicable Disease Dynamics and Associate Medical Director of Microbiology, Brigham and Women’s Hospital, Harvard Medical School” has a piece out in Time magazine outlining how we can stop the coronavirus pandemic by Christmas without a lockdown or having to wait for vaccines.

In summary, we need at-home rapid antigen tests that are currently being held up by the FDA bureaucracy. From Time:

The antigen test technology exists and some companies overseas have already produced exactly what would work for this program. However, in the U.S., the FDA hasn’t figured out a way to authorize the at-home rapid antigen tests because the FDA is used to regulating medical devices, not public health screening tools. Thus, every test that is authorized, regardless of whether it is designed for medicine or public health, is authorized as a clinical medical device. Requiring public health tools to meet medical device specifications has caused company after company to delay their FDA submissions in a never ending attempt to meet the FDA’s guidelines—for example the need to separately qualify a rapid antigen test for symptomatic versus asymptomatic use.

And here’s Dr. Mina with a must-read thread on what needs to be done to get these at-home tests in use right now:

Let’s get this done!



Tags: FDA