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COVID-19: FDA Clears Path for Test to Screen Asymptomatic Individuals

The difficulties in accessing laboratory testing and securing prompt results present continuing challenges in the fight to control COVID-19.  With scarce availability, there have been some attempts to limit tests to, or prioritize tests for, those with symptoms or who serve in essential roles, such as healthcare workers.  However, there clearly remains a need, and a demand, for testing for asymptomatic individuals.  

Current Status of Asymptomatic Testing

Currently, FDA has not authorized a COVID-19 test for asymptomatic surveillance despite many employers, including professional athletic teams, requiring testing of asymptomatic individuals. Even some states require such testing.  For example, as part of its Keep Maine Healthy initiative, Maine is requiring visitors from other states to: 1) get a recent negative COVID-19 test in advance of entering; 2) maintain compliance with a 14-day quarantine upon arrival in Maine; 3) or enjoy an exemption if the visitor is from nearby states with a similar or better COVID-19 experience than Maine. Visitors must sign a Certificate of Compliance attesting to compliance with the aforementioned requirements. 

To date, FDA has only authorized molecular diagnostic tests for symptomatic, pre-symptomatic, or asymptomatic individuals suspected of having COVID-19 by their healthcare provider. Testing compliant with FDA authorization is only possible on the theory that healthcare providers have the discretion to test asymptomatic individuals when, in the professional judgement of the healthcare provider, a COVID-19 test is warranted for a particular individual, although compliance with that standard may be suspect. 

FDA’s June 16, 2020 Statement

In this context, FDA released a statement, Coronavirus (COVID-19) Update: Facilitating Diagnostic Test Availability for Asymptomatic Testing and Sample Pooling, which outlines the steps for a test to be authorized for broad screening of asymptomatic individuals.  The statement provides information for test developers on the FDA’s expectations for how these tests can be validated for screening of asymptomatic individuals. 

In its recent statement, FDA has acknowledged that organizations may want to conduct screening of asymptomatic individuals as part of a broader strategy to help ensure the safety of their employees, patients, students, and others. FDA provided updated templates for test developers to  use in connection with developing and validating test for broad screening of asymptomatic individuals, including FDA’s expectations for developers of molecular diagnostic tests who intend for their assays to be used for pooling patient samples or for screening asymptomatic individuals not suspected of having COVID-19. FDA also made available additional FAQs with information regarding tests for screening asymptomatic individuals. 

Impact

FDA’s latest statement provides a quicker pathway for approving more tests, which will be a necessity as the U.S. continues reopening, and employers, for example, devise plans for how to bring people back to the workplace safely.

© 2020 Foley & Lardner LLPNational Law Review, Volume X, Number 205
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About this Author

Kyle Faget, Foley Lardner, Government policy lawyer
Special Counsel

Kyle Faget is a special counsel and business lawyer with Foley & Lardner LLP. She is a member of the firm’s Government & Public Policy Practice and the Health Care and Life Sciences Industry Teams. Her practice focuses on advising clients on regulatory and compliance matters involving the Food, Drug & Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the AdvaMed Code, and the PhRMA Code. She also regularly drafts and negotiates agreements required for the development and commercialization of pharmaceutical and medical device products. Prior to...

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