FDA halts COVID-19 in-home test kits in Seattle

SEATTLE — The Food and Drug Administration temporarily shut down the Seattle Coronavirus Assessment Network (SCAN) operating in King County.

The program, centered at the University of Washington, sent free test kits to participants. The participant could use the swab in their nose and send it back to the UW lab.

Results were available in a couple of days, until Wednesday — that was when the FDA stepped in.

According to the FDA, the program needs federal emergency use authorization (EUA) before it can release results to participants.

It isn’t the first time these researchers hit a roadblock.

Inside this same University of Washington lab, Dr. Helen Chu was the first to identify the community spread of coronavirus in the United States.

She found it when she started testing swabs sent in as part of the Seattle Flu Study.

Even after being told by federal and state officials the flu study couldn’t be refigured to test for COVID-19, she and her colleagues argued there should be more flexibility in an emergency.

In March, they received EUA from the state. Now, two months later, the FDA states the lab needs federal authorization too.

The SCAN program is heavily funded by the Gates Foundation. The lab has the ability to test 1,000 swabs a day.

Dr. Chu determined many of the people who took the home test weren’t sick enough to go to the doctor. She says the test kits are a valuable way to identify those patients to make sure they stay home.

While SCAN can’t process tests right now, they have an online survey you can take about your own health, and they’re asking parents for information about their children as researches work to find out more about the spread of COVID-19.