OPINION: FDA’s Policy Changes For COVID-19 At-Home Diagnostics—Implications For Addressing Other Infectious Diseases And Future Pandemics

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The response to the COVID-19 pandemic in the US has been transformed through new technologies. The speed of progress in combatting this pathogen has outpaced the advances made against perhaps any similar public health threat over any comparable period. The rapid introduction of 3 highly effective vaccines, the development of monoclonal antibody drugs—and most recently, antivirals that are taken orally—have offered a potent armamentarium to reduce the adverse effects of SARS-CoV-2 infection.

Perhaps one of the most enduring technological innovations will be the advent of accurate diagnostic tests that can be used at home to provide a rapid answer about a person’s clinical status.1 As a result of the regulatory framework fashioned to advance these tests, the technology and commercial pathway to provide them directly to consumers, and the cultural change they have ushered in, our approach to care will have lasting consequences beyond COVID-19 and to how we address other infectious diseases.

In the future, home diagnostic tests will be increasingly coupled with telemedicine visits to introduce rapid assessment into the home for a range of pathogens, such as group A Streptococcus, influenza virus, respiratory syncytial virus, and many more. These virtual visits will be tethered to more definitive diagnostic tests, such as polymerase chain reaction, with delivery of such test kits to a patient’s home and same-day return to the laboratory for conclusive confirmation that a negative test result from an at-home, rapid diagnostic device was not a false-negative result.

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