The Food and Drug Administration has halted an at-home coronavirus testing program by Seattle Coronavirus Assessment Network or SCAN, which is backed by Bill Gates, for lack of proper approval.
In an update of the project on its website, SCAN said its testing of home-based, self-collected samples for COVID-19 is currently paused after the FDA notified that a separate federal emergency use authorization or EUA is required to return results for self-collected tests.
SCAN’s test is authorized by the Washington State Department of Health, but any coronavirus tests in the U.S. requires FDA’s emergency use authorization.
SCAN said, “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, a disease surveillance program, is a partnership involving Seattle and King County public health department and a number of institutions such as the University of Washington Medicine and Seattle Children’s Hospital, among others. It receives support from Gates’ private office, Gates Ventures, and as well as The Bill and Melinda Gates Foundation.
The project sends free self-swab test kits including a nasal swab to participants, who would then return it to a lab involved in the program without leaving home. The program has the capacity to analyze 1,000 tests a day.
In a blog post last week, Gates noted that early results from SCAN found many cases of COVID-19 in Seattle that might otherwise have gone undetected among individuals who had experienced some symptoms but had not yet sought medical care. Meanwhile, ongoing COVID-19 medical testing has been largely focused on people with symptoms.
Gates wrote that “as SCAN gathers more test results in the weeks ahead, researchers expect the new data to provide a better sense of the number of infections and serve as one source to help answer other questions, like when physical distancing measures can be relaxed.”
The FDA last week had approved Everlywell Inc.’s at-home sample collection kit for COVID-19 diagnostic testing, the first standalone sample collection kit to receive a proper EUA. The Test kits will be available for individual purchase by the end of the month, which can then send to specified laboratories for COVID-19 diagnostic testing.
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