Clint Hermes and Angelique Salib Examine Potential for At-Home COVID-19 Testing

October 12, 2020
AHLA Health Law Weekly

In an article for the American Health Law Association (AHLA), Bass, Berry & Sims attorneys Clint Hermes and Angelique Salib outline the benefits of at-home COVID-19 testing as a means to address the pandemic from a public health perspective. As part of the article, the authors examine the current regulatory regime applicable to in vitro diagnostic products, the Food and Drug Administration’s (FDA) deployment of emergency use authorizations, and challenges to bringing rapid, direct-to-consumer (DTC) tests to market.

The FDA’s current approach to approving emergency use authorizations for in vitro diagnostic products calls for a high standard of sensitivity and specificity. But that approach does not address unique concerns in the context of testing for purposes of a public health response, especially for a virus such as COVID-19 where asymptotic spread is prevalent and where the turnaround time for traditional laboratories are lengthy.

The authors discussed other scenarios during the COVID-19 pandemic that illustrate the FDA’s willingness to accept lower sensitivity testing in exchange for other public health benefits, such as pooled testing and in-care settings when processing times are prolonged or where highly sensitive tests are not available. Accordingly, the FDA has the authority and discretion, say the authors, to approve an emergency use authorization for a DTC test that is affordable, even if it means that the sensitivity threshold is lower.

The full article, “At-Home COVID-19 Testing and Pandemic Surveillance: A Regulatory Perspective,” was published on October 9 in the AHLA Health Law Weekly newsletter and is available online.