A COVID-19 testing program supported by Microsoft founder Bill Gates that sought to send test kits to anyone in the Seattle area who wanted one has been put on pause by the Food and Drug Administration.
The Seattle Coronavirus Assessment Network, which operates under the acronym of SCAN, sends test kits to the homes of people are who are healthy and those who are ill as a way to vault testing to a level that can inform government decisions on reopening communities.
Testing is conducted via a nasal swab that residents administer to themselves.
SCAN’s website framed the issue as a bit of bureaucracy with which it must deal.
“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 website said in a Thursday update.
“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.”
An unnamed FDA spokesperson told The New York Times that home testing kits caused concerns at the agency related to safety and accuracy.
“The issue in the Seattle case appears to be that the test results are being used not only by researchers for surveillance of the virus in the community but that the results are also being returned to patients to inform them,” The Times reported.
On its website, SCAN said: “There are no issues or concerns with the safety and accuracy of SCAN’s test.”
It said 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 United States.”
Existing state authorization of the test was not enough for the FDA, SCAN’s website said.
“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,” the site said.
In a recent blog post, Gates said the purpose of gathering data is “to paint a clearer picture of how COVID-19 is moving through the community, who is at greatest risk, and whether physical distancing measures are working.”
“One of the biggest questions puzzling public health officials is exactly how many people are infected with the virus,” Gates wrote, likening the pandemic to an iceberg.
“With ongoing COVID-19 medical testing, which has been largely focused on people with symptoms, we have been able to see the tip of the iceberg. Just below the surface, however, there is the part of the iceberg we don’t see — the unknown number of people who are infected but experience mild symptoms or no symptoms at all.”
Gates said that SCAN has shown promise.
“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 (fever, cough, or shortness of breath) but had not yet sought medical care,” he wrote.
“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,” Gates added.
He then explained how that takes place.
“Those test results are then analyzed by disease modelers to map virus transmission chains,” he wrote.
“By examining the genetic signature of an infection, they can determine whether it represents a new introduction to the region or is part of a local transmission. They can also use the data to estimate disease prevalence and build models to look at how the virus is responding to certain measures — like school closures and physical distancing.”
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