The SalivaDirect Initiative of the Yale School of Public Health (YSPH) will host its first annual conference on July 28-29, 2022 in Chicago, Illinois. Bringing together laboratory and industry professionals, researchers, and public health leaders, the agenda delves into the evolving role of saliva-based testing as a diagnostic solution for effective, efficient global emergency response efforts and improved public health, now and into the future.
“COVID-19 triggered a real need for and subsequent groundswell of interest in saliva-based testing, which makes sense to us,” said Yale Research Scientist Anne Wyllie, Principal Investigator of the SalivaDirect Initiative. “Patients win because they can non-invasively self-collect their own saliva; it’s pain-free. Importantly, research from us and others shows that saliva-based PCR tests can accurately detect SARS-CoV-2 — as soon as three days earlier during infection as compared to nasal swabs.”
Wyllie pivoted early during the COVID-19 pandemic when testing was disrupted by collapse of the global supply chain. Armed with a decade of research to refine saliva-based laboratory methods for the detection of Streptococcus pneumoniae, she applied her biomolecular expertise to SARS-CoV-2. Based on Wyllie’s eureka discovery, she and Yale colleagues innovated the saliva-based PCR test known as SalivaDirect. This innovation has been widely recognized, and even has been named a 2022 finalist in the Fast Company World-Changing Ideas Awards in the pandemic response category.
Specifically designed to be low cost, the SalivaDirect open-source COVID-19 PCR test can be performed with multiple types of readily available reagents and PCR equipment from different manufacturers, reducing supply chain pressure and enabling labs to easily scale testing without significant investment risk. The unique extraction-free SalivaDirect workflow eliminates the most costly and time-consuming part of the PCR process, while preserving test sensitivity.
Calling it an innovative game changer, the US FDA granted SalivaDirect an Emergency Use Authorization in August 2020 – among the first five saliva tests available in the country. The FDA collaborated with Wyllie to change the regulatory landscape by allowing the YSPH to extend the SalivaDirect EUA to other high-complexity labs -- thereby reducing regulatory barriers and speeding availability of much needed COVID-19 diagnostics.
Now almost two years into the pandemic, Yale has designated more than 180 high complexity molecular laboratories under its SalivaDirect EUA. Together they have performed over 6.3 million tests to date. Wyllie’s team continues to provide one-on-one onboarding assistance to speed use of its saliva-based PCR test. When laboratories started requesting additional labeling and workflows, Wyllie implemented a crowdsourcing model and harnessed the growing network as a development powerhouse. Collaborating across sectors and businesses, the SalivaDirect team, with input and data from its EUA labs, achieved more than 20 FDA EUA amendments – resulting in one of the most comprehensive SARS-CoV-2 test labels available. Efforts continue with EUA amendments for inclusion of additional reagents, saliva collection kits, and lab equipment.
As required by federal law, the SalivaDirect team routinely collects, analyzes and submits test-related data from all network labs to remain in compliance with its FDA EUA. This bimonthly regulatory process further honed the dozens of independent labs into an efficient network with the primary focus of providing broad access to low-cost, widely accessible COVID-19 testing. Dynamic communications also occur through biweekly video meetings, Google group email, a newsletter, and direct other correspondence.
“All SalivaDirect labs have been a vital part of SalivaDirect's past and present. I’m honored to call them colleagues and inspired by their dedication to the pandemic response” said Wyllie. “We’re especially motivated by the intention of so many laboratory leaders to align with SalivaDirect goals of increasing access to equitable testing for all communities.”
SalivaDirect hopes the current period of lighter COVID-19 testing demand allows generally over-overburdened lab professionals the time to gather in Chicago this month for reflection, planning and preparedness – especially for expected surges and new SARS-CoV-2 variants. During the two-day conference, international keynote speakers will report on research and industry experience during the pandemic. Participants will share pandemic learnings, participate in facilitated panel discussions, and discuss future needs for improved large-scale infectious disease testing response.
“Together, we will identify new opportunities to apply saliva-based testing,” concluded Wyllie. “Also, I’m confident we will learn how best to continue supporting our SalivaDirect laboratory partners as public health champions both in their contributions to research and to healthcare in their communities.”
Together, we will identify new opportunities to apply saliva-based testing.
Anne Wyllie
Space at this inaugural event is limited and attendees are encouraged to register soon at SalivaDirect Conference.
About The SalivaDirect Initiative
SalivaDirect is an International Saliva Diagnostics Initiative advancing its open-source SARS-CoV-2 PCR testing protocol to support laboratory partners worldwide. As a not-for-profit within YSPH, the SalivaDirect Initiative is on a mission to advance the use of saliva-based testing as a readily-deployable, sensitive, patient-friendly option that increases access to affordable and equitable infectious disease diagnostics. Scaling quickly, the SalivaDirect Laboratory Network now includes more than 180 designated CLIA laboratories in 41 states and US territories. Collectively the network has administered more than 7.0 million SalivaDirect PCR tests to date. The SalivaDirect test also has been independently validated internationally in at least 12 countries.
With the support of Yale and other organizations, including the Rockefeller Foundation, Fast Grants, Tempus Labs, and Lighthouse Lab Services, SalivaDirect continues to expand its reach in the United States and around the world. SalivaDirect also receives support from Flambeau Diagnostics LLC, which is funded in part by the NIH Rapid Acceleration of Diagnostics© (RADx) initiative with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health under Contract No. 75N92020C00017. The contract is funded from the Public Health and Social Services Emergency Fund through the Biomedical Advanced Research and Development Authority, HHS Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services.
How to Obtain SalivaDirect EUA Designation
Laboratories interested in obtaining formal designation to administer the SalivaDirect open-source SARS-CoV-2 PCR protocol should visit the Designation Process page at SalivaDirect.org. By completing this Lab Authorization Request Form, labs can initiate the designation process today. With all necessary documentation in hand, many labs complete this process in three to four business days.
Important Regulatory Information
SalivaDirect has not been FDA cleared or approved but is authorized for emergency use by the FDA under an EUA for use by authorized laboratories. SalivaDirect has been authorized only for the detection of nucleic acid form SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is revoked sooner.