The Food and Drug Administration (FDA) has indefinitely suspended a coronavirus testing program that has been highly praised by billionaire Bill Gates.
The Seattle Coronavirus Assessment Network (SCAN), in part backed by the Bill and Melinda Gates Foundation, had been testing about 300 people per day before the FDA shut down the program, according to Reuters. The program allowed Seattle residents to swab themselves in a test and send the nasal samples to a lab.
In a statement posted to its website, SCAN said officials for the program are working with FDA regulators to resume the program.
“The Food & Drug Administration (FDA) recently clarified its guidance for home-based, self-collected samples to test for COVID-19. We have been notified that a separate federal emergency use authorization (EUA) is required to return results for self-collected tests. The FDA has not raised any concerns regarding the safety and accuracy of SCAN’s test, but we have been asked to pause testing until we receive that additional authorization,” the statement said.
We have been in conversation with the FDA since March 1st and hope to have our EUA soon. We initiated the process to authorize our lab-developed test and self-swab kit on March 23rd and, in accordance with the EUA process and timeline, submitted data to secure federal authorization on April 13th. We are actively working to address their questions and resume testing as soon as possible.
We are pleased to see the FDA’s recent clarifications regarding provisions for home-based self-collection of diagnostic samples in specific circumstances. This paves the way toward expanding access to safe, reliable, convenient, and scalable testing options across the country.
We are grateful for productive partnerships with the FDA, the Washington State Department of Health, and the Centers for Disease Control and Prevention as we continue to respond to this unprecedented and rapidly evolving outbreak.
In March, the Gates Foundation announced it would provide technical assistance for SCAN. In addition, a vaccine trial by Inovio was able to produce thousands of doses “in part thanks to backing from the Bill and Melinda Gates Foundation, as well as funding from other nonprofits and organizations.”