Bill Gates-funded COVID-19 tracking program paused due to concerns from the FDA
Seattle Coronavirus Assessment Network (SCAN), a Bill Gates-funded COVID-19 tracking program, has
been shut down been paused due to concerns from the U.S. Food and Drug Administration (FDA), according to reports. The Seattle-based initiative has been ordered to halt its at-home coronavirus testing scheme by the federal authorities.
The FDA has ordered SCAN to stop screening for the virus, putting the program, that has been providing hundreds of home testing kits each day, on pause.As of Wednesday, all links to the project’s website now redirect to a notice stating its operations are “currently paused” due to a conflict with the FDA.
In a statement on its website date May 14, SCAN said the following:
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.”
The organization added: “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 the FAQ section of the announcement, SCAN tries to re-assure its customers that the sudden pause has nothing to the safety and accuracy of its test. Here’s what SCAN said.
Q: Why did SCAN pause so suddenly? Was there something wrong with the test?
A: There are no issues or concerns with the safety and accuracy of SCAN’s test. The FDA recently clarified its guidance for home-based, self-collected samples to test for SARS-CoV-2, the virus that causes COVID-19. These requirements establish common guidelines for at-home testing in the U.S.
While SCAN’s test remains authorized by the Washington State Department of Health, we have been notified that a separate federal emergency use authorization is required to return results for tests of self-collected specimens. On May 12th, the FDA asked that we pause testing until we have received this additional authorization.
SCAN is working with the FDA and Washington State Department of Health to resume testing and notification of results as soon as possible.
Important Update: The title of this article has been changed from: Bill Gates-funded COVID-19 tracking program has been shut down by the FDA. However, new reports now show that the program is been put on hold due to concerns from the FDA.