Regulators have blocked the Seattle Flu Study’s guerrilla effort to trace the spread of novel coronavirus, citing ethical concerns, but leaders of the effort say they’re working out an alternate path to continue their investigation.
The Seattle Flu Study was set up last year by leaders in the biomedical community — including the Brotman Baty Institute for Precision Medicine, the University of Washington, the Fred Hutchinson Cancer Research Center and Seattle Children’s Hospital — to use genetic tools to study how influenza spreads.
When the SARS-CoV-2 coronavirus started spreading like wildfire through China and other countries, the team began analyzing the samples they were receiving for evidence of the virus’ genetic fingerprint. And when evidence was found, the results were sent onward to public health authorities for follow-up. At least one patient in Snohomish County was identified as a coronavirus case thanks to the team’s work.
The underlying rationale for federal regulation of diagnostic assays is undisputed, but it was absolutely maddening trying to find a solution that would allow use of our high-throughput research assay for #COVID19 testing through much of Feb. 1/4https://t.co/t0MdumLHDs
— Trevor Bedford (@trvrb) March 11, 2020
By comparing the evolutionary changes in the virus’ RNA code, as reflected in Seattle Flu Study samples, epidemiologists determined that the virus had been spreading for six weeks in the United States without being detected — and that by that time, hundreds of people in the Seattle area were probably carrying the COVID-19 infection without knowing it.
Those findings arguably played a crucial role in bringing the coronavirus threat to light in the United States, at a time when public health agencies had extremely limited capability to test for the virus. There was a problem, however: The Seattle Flu Study’s coronavirus test hadn’t been cleared for clinical use by the Food and Drug Administration. Researchers had regulatory clearance to use their findings for research, but not for diagnostic purposes.