As the U.S. continues to struggle to make COVID-19 tests available for symptomatic and asymptomatic individuals, FDA’s position regarding COVID-19 test standards is evolving.  The FDA’s pivot is possibly a response to industry’s plea to facilitate the type of large-scale screening and testing needed to reopen the country.  Last week, the FDA took steps to make testing more accessible to asymptomatic individuals, including with new guidance and authorizations for pooled testing and for testing of asymptomatic individuals.  With the FDA’s latest guidance, it is also taking steps to make testing available on an over-the-counter basis.  Such steps clear the way for companies to continue to innovate in new ways with a clearer path towards FDA authorization. 

As previously reported, the FDA recently began to identify a path for screening of asymptomatic individuals, and on July 24, 2020 the FDA authorized the first diagnostic test for people who do not have COVID-19 symptoms or who have no reason to suspect COVID-19 infection.  A second authorization for pooled sample testing was also released; the first authorization for pooled sample testing was issued on July 18, 2020.  Despite these gains, barriers to testing continue.  For example, pursuant to the emergency use authorizations (EUAs) issued by the FDA to date, all COVID-19 testing must be performed by certified laboratories and may only be conducted pursuant to an order by a healthcare provider (apart from a small number of point-of-care tests). 

On July 29, 2020, FDA signaled further efforts to allow more expansive testing in its release of its statement, Coronavirus (COVID-19) Update: FDA Posts New Template for At-Home and Over-the-Counter Diagnostic Tests for Use in Non-Lab Settings, Such as Homes, Offices or Schools, that includes a new template for commercial developers to assist with development and submission of EUA requests for COVID-19 diagnostic tests that can be performed entirely at home or in other settings besides a certified laboratory, such as offices or schools, and that could be available without a prescription.  As FDA Commissioner Stephen M. Hahn, M.D. was quoted saying in the statement, the tests contemplated by the template are “intended to help get tests to market that are simple enough to use at home, similar to a pregnancy test.”

The template includes important recommendations to developers regarding validation, including (1) when a sample is to be collected and analyzed, and results are to be returned without the need to send a sample to a certified laboratory for analysis; and (2) for tests that are intended to be made available over-the-counter without a prescription.  The template also outlines the recommended sensitivity levels for these types of tests signaling that lower sensitivity levels will be permitted, as compared to laboratory tests, because the benefits of broader testing will outweigh the risks posed by a lower sensitivity test.

Impact

Once authorizations are issued for over-the-counter testing, tests could be bought at a local drug store without a prescription and performed at home, which would be a “game changer” for those hoping to engage in broad scale test screening, such as employers who are continuing to implement their back-to-work action plans.  To date, such efforts have been met with multiple hurdles, including how to order such tests to be compliant with existing EUAs.  An at home test akin to a pregnancy test would solve many of the hurdles faced by those interested in convenient, cost-effective, and widely available testing of asymptomatic individuals.  The FDA’s announcement together with FDA’s recent authorization for testing individuals without known or suspected COVID-19 infection, and its approved use of pooled samples, suggests that FDA is working toward making COVID-19 testing both efficient and widely available.  This approach will also likely have the effect of incentivizing innovation both in testing technology and peripheral applications, such as digital platforms that can digitize, encrypt, transmit, and store testing data.