FDA suspends coronavirus testing program backed by Bill Gates

In this file photo, a vial and swab for a COVID-19 test are shown during the new coronavirus pandemic, Thursday, April 16, 2020, in Miami.(Lynne Sladky/AP)

A coronavirus testing program lauded by billionaire Bill Gates has been indefinitely suspended by the Food and Drug Administration.

The Seattle Coronavirus Assessment Network or SCAN, which is in part backed by the Bill and Melinda Gates Foundation, was testing an estimated 300 people a day before efforts were shut down by the FDA, according to Reuters. The home-based procedure involves sending Seattle citizens self-swab tests and returning the nasal samples to a lab, even when they are not showing symptoms

In a statement posted to its website, SCAN said it is working with U.S. regulators to resume the program after the FDA ordered it receive emergency approval first.

“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,” it said.

The issue instead is with the categorization and use of the tests. An FDA spokesperson told the New York Times they’re labeled as surveillance tests, which can only be used for research and not diagnostic purposes. Because the tests were being returned to patients, the FDA ruled that the program needed to be subjected to its guidelines for diagnostic testing.

The Gates Foundation in March announced it was providing technical assistance for SCAN, which had been approved by regulators in Washington state — one of the first U.S. states to be hit by the coronavirus pandemic.

Gates has also privately funded SCAN, according to the foundation.

In a blog post titled “Scanning for answers to a pandemic," Gates said he was “excited” about the initiaive just days before it was put on hold.

“I want to be clear that SCAN does not replace the widespread testing that is still needed in communities. But it has the potential to become an important tool for health officials seeking insights about the spread and behavior of the virus," he wrote.

“Early results from SCAN found many cases of COVID-19 in Seattle that might otherwise have gone undetected.”

He added the test results as well as additional information — including age, gender, race, zip code, and underlying health conditions — would be used by researchers, data modelers, and health officials to examine the spread of COVID-19 and identify at-risk demographics.

SCAN is also headed by five medical organizations the Seattle and King County Public Health Department, the Brotman Baty Institute, the medicine faculty University of Washington, the Fred Hutchinson Cancer Research Center, and the Seattle Children’s Hospital.