FDA halts at-home Corona test kit program in Seattle

Seattle - Jay Huang - Licensed under CC BY 2.0

Seattle’s at-home test kits could have become a vital resource in testing individuals for the coronavirus until the FDA shut down the process.

On May 12, Microsoft co-founder Bill Gates announced an at home COVID-19 detection kit, which would not only allow testing more individuals in quarantine but also gathers surveillance of the virus’s spread across the Greater Seattle area. The Seattle Coronavirus Assessment Network program tests a variety of people, healthy and those with symptoms, by letting them use a self-swab test. Once samples have been collected, they are sent back to a lab to collect test results. The data collected tracks the virus’s spread throughout communities and observe if social distancing measures are working. While Gates stated the program is surveillance-based and not a substitute for increased widespread testing, he wrote, “[SCAN] has the potential to become an important tool for health officials seeking insights about the spread and behavior of the virus.”

 SCAN was suspended by the Food and Drug Administration because the program required emergency use authorization. The issues with the program were not related to safety concerns, rather a problem with the categorization of the tests. The guidelines for the original approval of the tests were because it was a surveillance program. However, once the samples were tested, participants were notified if they were infected with the virus. As informing patients and doctors is against FDA guidelines, SCAN tests could no longer be sent to the public.

Dr. Eric Topol, director of the Scripps Translational Science Institute, stated that at-home testing is the only way to fight against the pandemic. In response to denying test results to SCAN patients, Dr. Topol noted, “To withhold that information from people is downright absurd.” In a time of rapid infections across the nation, and a lack of testing available, the halt of the SCAN raises concerns on how to test the outbreak realistically.

The current method of testing has been patients with symptoms going through a drive-through clinic, which still has the potential of exposing others to the virus. The accessibility of at-home testing would not only prevent the spread but also provide results efficiently. While the FDA has begun to approve some at-home tests from various companies, those tests are available only by prescription and start at $135 per test.

Currently, 93,400 Americans have died from the virus, with over 1.5 million testing positive. While states desire to begin opening up, widespread testing resources remain limited. A Harvard Global Health Institute study gathered the number of testing states must be done per day, with most states having only met 1/3 of the testing recommendation.

Additional concerns are presented to the reopening of states as a recent report from the Center for Infectious Disease Research and Policy informed, “Current plans for clinical and public health laboratory testing do not sufficiently address the infrastructure needed to perform such tests.” In addition to a lack of being able to perform such tests, states also face issues of shortages with supplies, like swabs, to successfully continue lab testing and efficiently produce results.

While the benefits of at-home testing remain unclear, the process of testing coronavirus at home could revolutionize the way testing happens for years to come. “If technology can be reduced and simplified, so it’s easy to use and home-based. Theoretically, you can use it to find any pathogen with DNA or RNA,” shared Donald Thea, a professor of global health at Boston University. “There’s going to be a real revolution in viral diagnostics, and coronavirus is really accelerating that. That’s one of the unintended but hopeful consequences of a truly horrible situation.”

Programs like SCAN are not the solution to the coronavirus pandemic. But they are a step in the right direction in a future based on the need for accessible testing. Halting such programs could keep sending Seattle and many other communities backward in the fight against the pandemic.