The White House has invited Anne Wyllie, principal investigator of the SalivaDirect Initiative at the Yale School of Public Health, to participate today with global leaders from government, academia, industry and elsewhere in the White House 2021 Global COVID-19 Summit: Ending the Pandemic and Building Back Better to Prepare for the Next.
The virtual global summit hosted by the United Nations requires participants to make substantial commitments in funding, expertise, technological innovation, and capacity to tackle obstacles in vaccination, testing and treatment of SARS-CoV-2 and future pathogens.
“It’s an honor to be part of President Biden’s call-to-action to rapidly end the current pandemic and to fortify nations against future biological threats,” said Wyllie, Ph.D., a research scientist at the Yale School of Public Health. “We’ve worked tirelessly as a team to build usership of the SalivaDirect protocol as a new public health paradigm which provides effective, affordable SARS-CoV-2 testing capacity to our communities in need, helping them to safely reopen.”
Specifically, Wyllie’s team committed to:
- The continued designation of qualified labs that seek to test under SalivaDirect’s emergency use authorization.
- The ongoing regulatory stewardship of its EUA.
- Supporting communities around the world in need of sustainable COVID-19 diagnostic and surveillance test options to help save lives.
Developed by Wyllie’s team at the Yale School of Public Health, SalivaDirect is designed to be inexpensive by using readily available reagents and PCR equipment from numerous suppliers. It is currently available under the U.S. Food and Drug Administration’s Emergency Use Authorization (EUA), received in August of 2020.
The SalivaDirect team has demonstrated that saliva is at least as sensitive – and in some cases better – for detecting SARS-CoV-2 compared to the nasopharyngeal sample type. Testing saliva also eliminates the need for nasopharyngeal or nasal swabs, which have been prone to shortages, and alleviates patient discomfort as they are non-invasive and pain-free, appealing to individuals who have previously been hesitant to test.
SalivaDirect has scaled quickly over the past year and is currently deployed in at least 39 states, six countries and has partnerships with over 140 organizations, including the U.S. National Basketball Association. Over two million SalivaDirect tests have been administered so far.
The EUA allows the FDA to help strengthen the nation’s public health protections against various threats, including infectious diseases, by facilitating the availability and use of medical countermeasures needed during public health emergencies. Calling the SalivaDirect test an innovative game changer, the FDA flexed its technical expertise by allowing Yale to extend its EUA to other high-complexity labs that follow its instructions for use—thereby reducing regulatory barriers to much needed COVID-19 diagnostics.
“SalivaDirect at Yale School of Public Health proudly responds to President Biden’s global call to end the testing gap in America and worldwide,” Wyllie said. “Our commitment includes continuing the designation of qualified labs that seek to test with the SalivaDirect protocol, providing ongoing regulatory stewardship of the EUA, and advancing our testing support for communities around the world in need of sustainable COVID-19 diagnostic and surveillance test options. We are 100% on board with President Biden’s global call to Save Lives Now.”
For more information about SalivaDirect, visit www.salivadirect.org
Media Contact: Michael Greenwood, michael.greenwood@yale.edu