Citing emerging scientific data, the FDA said that the drugs were “unlikely to be effective in treating COVID-19” and that the potential benefits don’t outweigh the known risks, including the incidence of serious cardiac events. For those reasons, the legal criteria for issuing an emergency use authorization “are no longer met,” the FDA said.
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.”
The Food and Drug Administration is warning consumers about unauthorized kits that are being marketed to test for coronavirus in the home.
“At this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19,” the agency said today in a news release.
Several companies have begun marketing test kits that let consumers to take their own samples, using nasal swabs and/or saliva collection kits, and then send them in to a lab for analysis. In some cases, the consumer is asked to provide a spit sample, as an alternative or a backup. In today’s alert, the FDA left the door open for the use of such tests.