VIDEO - Coronavirus-tracking project gets put on hold due to FDA concerns

SCAN makes use of at-home collection of nasal samples. (GatesNotes via YouTube)

The organizers of the Seattle Coronavirus Assessment Network, a virus-tracking project supported by Microsoft co-founder Bill Gates, say their efforts are being paused while they deal with concerns raised by the Food and Drug Administration.

Word of SCAN’s suspension came just a day after the world’s second-richest person praised the effort in GatesNotes, his personal blog. “It has the potential to become an important tool for health officials seeking insights about the spread and behavior of the virus,” Gates wrote.

SCAN aims to track the spread of the virus that causes COVID-19 throughout the Seattle area by sending out at-home tests and picking them up for analysis, with logistical support from Amazon Care, the health care program for Amazon employees. Over the past seven weeks, tests have been sent out to about 12,500 test subjects, including people with symptoms and people without symptoms.

The project had been operating under an arrangement by which the FDA let state public health officials issue Emergency Use Authorizations for coronavirus tests developed within their states. Today, SCAN said it was notified that separate federal authorization is now required to return test results, due to revisions in the guidance that were issued last week.

SCAN said it’s been working to address the FDA’s questions and hopes to have full authorization “soon.”

According to SCAN, the FDA is seeking data about the self-swab technique that’s being used for the at-home tests, and about the testing of people who aren’t reporting symptoms.

SCAN’s organizers said they’ve drawn upon the experience gained since the project began on March 23, as well as their experience with an earlier project known as the Seattle Flu Study.

“With regard to proper specimen collection outside of a clinical setting, our experience from more than 18 months of sampling with the Seattle Flu Study and now SCAN also shows a low rate of insufficient nasal sampling,” the organizers said in today’s blog posting. “The internal control in our assay readily identifies whether a sufficient specimen is collected.”

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The organizers also said it was important to test subjects who aren’t feeling sick. “This can not only help us learn more about the virus, it can help us identify positive cases of COVID-19 that might otherwise go undetected,” they said.

Separate efforts that focus on people in homeless shelters and long-term care facilities can continue under the banner of the Seattle Flu Study because the sampling is supervised by health care workers and doesn’t involve self-swabbing.

This isn’t the first time regulators have made things complicated for the Seattle research team. The Seattle Flu Study’s pilot project to track the spread of coronavirus also ran into roadblocks. Despite the difficulties, that project found the first evidence tracing the virus’ community transmission within the U.S.

SCAN is a partnership between the Seattle Flu Study and Public Health – Seattle & King County. It’s funded by Gates Ventures, the private office of Bill Gates, and is getting technical guidance from experts at organizations including the Bill & Melinda Gates Foundation and the Centers for Disease Control and Prevention. The Institute for Disease Modeling provides data modeling support.

The Seattle Flu Study was developed by the Brotman Baty Institute in league with UW Medicine, the Fred Hutchinson Cancer Research Center and Seattle Children’s. University of Washington geneticist Jay Shendure is the Brotman Baty Institute’s scientific director as well as the Seattle Flu Study’s lead principal investigator.

https://www.geekwire.com/2020/coronavirus-tracking-project-backed-bill-gates-gets-put-hold-due-fda-concerns/