FDA Stops Home Testing Program From Group Who Discovered First Case of Community Transmission in Washington State

Testing by the Seattle Coronavirus Assessment Network (SCAN) was halted Thursday after a request from the Food and Drug Administration (FDA), which stated SCAN needed additional federal authorization to continue the program.

SCAN, which had been operating in cooperation with Washington state and county public health officials, delivered home tests for the virus and analyzed the results of the self-administered nasal swabs. In February, SCAN researchers uncovered evidence of the first instance of community spread of the virus in that area. After the notice from the FDA, the program is prohibited from both accepting new tests and providing those who have already taken the test with results.

"The Food & Drug Administration (FDA) recently clarified its guidance for home-based, self-collected samples to test for COVID-19," read a Thursday statement from SCAN. "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."

SCAN had received financial support from Gates Ventures, a venture capital firm started by Microsoft founder Bill Gates. In a Tuesday blog post, Gates praised the program as a way to elevate the understanding of the spread of the virus throughout Seattle and around the world.

Newsweek reached out to SCAN and Gates Ventures for comment. This story will be updated with any response.

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Requiring more authorization, the FDA halted the efforts of a Washington State group conducting analysis of in-home testing. iStock/Getty

Currently, the FDA has not approved any in-home testing kits. However, one at-home test from LabCorp was granted an emergency use authorization by the FDA in April. Originally only supplied to health care providers, the test allows users to swab their own noses and send the specimens to a laboratory for analysis.

EUAs can be issued to "allow unapproved medical products or unapproved uses of approved medical products" in an emergency to treat serious medical conditions, such as coronavirus.

Hydroxychloroquine, a malaria drug touted by President Donald Trump as a potential therapeutic for the virus, received an EUA from the FDA and is part of the Strategic National Stockpile. Hospitals may request the drug from the stockpile as a treatment for the virus. Clinical trials of the drug, administered with the antibiotic azithromycin, began in the U.S. on Thursday.

Studies in other countries have cast doubt on the effectiveness of hydroxychloroquine in the fight against coronavirus. An April study of the drug published in the U.K. did not "support the view that hydroxychloroquine is effective in the management of even mild COVID-19 disease."

Michigan Democratic State Representative Karen Whitsett praised the drug in April, saying that it "saved her life." When she experienced a rapid onrush of coronavirus symptoms, Whitsett took hydroxychloroquine which she credits for making her feel better "within a couple hours."

"If President Trump had not talked about this," Whitsett said, "it would not be something that's accessible for anyone to get, not right now."