The U.S. Food and Drug Administration (FDA) recently eased a significant regulatory barrier to at-home COVID-19 testing. On May 6, 2020, the FDA issued a policy facilitating patient access to sample collection kits in a step highly-anticipated by patients, providers, industry, employers who want to maintain a safe work environment before employees come back to work, and other public health stakeholders. This need was highlighted in March but for nearly seven weeks, individuals have been required to leave their homes and obtain testing from clinics staffed by healthcare workers, frustrating the nation's efforts to manage the pandemic through social distancing. Under the new paradigm, however, the public will be able to swab their noses and submit samples through the mail for analysis by commercial laboratories.
In response to the public demand for at-home testing, the FDA voiced concerns over self-specimen collection including whether the lay user can safely and properly collect the specimen, whether the components of the specimen transport media are safe for use in the home environment, proper shipment, and adequate stability of the specimen given the time lapse between collection and testing and the potential impact of shipping conditions. However, it appears these concerns have been mitigated based on testing submitted to the FDA.
The FDA recently reviewed analytical validation data from a swab stability that can be used, in conjunction with other data, to support sample stability of certain nasal swabs with authorized COVID-19 molecular diagnostic assays. The study was conducted by Quantigen Biosciences who has granted a right to reference to any manufacturer wishing to pursue an Emergency Use Authorization (EUA) to leverage Quantigen Biosciences' swab stability data as part of the manufacturer's EUA request. The FDA points out that leveraging the swab stability data addresses specimen stability and shipping questions but may not address usability questions. Therefore, developers wishing to pursue EUAs for COVID-19 molecular diagnostic assays including self-collection of a specimen at home are encouraged to reach out to FDA to discuss additional validation and information necessary to support an EUA request. In addition, distributors of home collection systems can contact the Pipeline and Hazardous Materials Safety Administration (PHMSA) within the Department of Transportation (DOT) to confirm that the packaging and shipping instructions will ensure users are in compliance with the hazardous materials regulations for shipping medical material.
Given the recent developments, EUAs leveraging the swab stability data are to be a focal point at the FDA's May 13 virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for COVID-19. The FDA Commissioner has stated "authorizing additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for COVID-19. This provides an additional option for the easy, safe and convenient collection of samples required for testing without traveling to a doctor's office, hospital or testing site."
The new policy is expected to result in more EUAs being granted for home collection, which should help ramp up the country's testing capacity. Last month, the FDA granted an EUA to LabCorp for the first diagnostic test with a home-collection option, which uses a sample collected from the patient's nose with a nasal swab. And on May 8, the FDA issued an EUA to Rutgers Clinical Genomics Laboratory for the first COVID-19 diagnostic test using an at-home collection of saliva specimens.
