SCAN Project Update May 14, 2020
Thank you for your interest in the Seattle Coronavirus Assessment Network (SCAN). Our testing of home-based, self-collected samples for COVID-19 is currently paused. We sincerely apologize for the inconvenience.
SCAN’s test is authorized by the Washington State Department of Health. However, 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.
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.
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