First Annual Saliva-Based Testing Conference hosted by The SalivaDirect Initiative, Yale School of Public Health on July 28-29, 2022 in Chicago, IL


Experts explore Lessons learned from COVID-19 on saliva testing and its role as a diagnostic solution to improve future public health and global emergency response

Limited space! Please register on SalivaDirectConference.com

NEW HAVEN, Conn., July 8, 2022 /PRNewswire/ — The Yale School of Public Health (YSPH) SalivaDirect Initiative will hold its first annual conference on July 28-29, 2022 in Chicago, Ill.. Bringing together laboratory and industry professionals, researchers and public health officials, the program examines the evolving role of saliva-based testing as a diagnostic solution for emergency response efforts. effective and efficient global emergencies and improved public health, now and in the future.

“COVID-19 has triggered a real need and a surge of interest in saliva-based testing, which makes sense to us,” the Yale researcher said. Anne Wylie, PhD, principal investigator of the SalivaDirect initiative. “Patients win because they can self-collect their own saliva non-invasively; it’s painless. Importantly, our research and that of others shows that saliva-based PCR tests can accurately detect SARS-CoV-2 – as early as three days earlier during infection compared to nasal swabs.”

Wyllie pivoted at the start of the COVID-19 pandemic when testing was halted by the 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 eureka discoveryher and Yale his colleagues pioneered the saliva-based PCR test known as SalivaDirect. This innovation has been widely recognized, and was even named a 2022 finalist at the fast business World-Changing Ideas Awards in the Pandemic Response category.

Specifically designed to be inexpensive, the SalivaDirect open source COVID-19 PCR test can be performed with multiple types of readily available PCR reagents and equipment from different manufacturers, reducing supply chain pressure and enabling laboratories to adapt tests easily without significant investment risk. SalivaDirect’s unique no-extraction workflows eliminate the most expensive and time-consuming part of the PCR process, while preserving assay sensitivity.

Calling it an innovative game changer, the US FDA granted SalivaDirect an emergency use authorization in August 2020 – among the top five saliva tests available in the country. The FDA worked with Wyllie to change the regulatory landscape by allowing YSPH to expand EUA SalivaDirect to other high-complexity labs, reducing regulatory hurdles and accelerating the availability of much-needed COVID-19 diagnostics.

Now almost two years into the pandemic, Yale has designated more than 180 high complexity molecular laboratories as part of its SalivaDirect EUA. Together they have performed more than 6.3 million tests to date. Wyllie’s team continues to provide one-on-one onboarding support to expedite the use of its saliva-based PCR test. When labs started asking for additional labeling and workflows, Wyllie implemented a crowdsourcing model and leveraged the growing network as a development powerhouse. Working with all industries and companies, the SalivaDirect team, with input and data from its EUA labs, has secured over 20 EUA amendments from the FDA, resulting in one of the SARS test labels -CoV-2 most comprehensive available. Efforts continue with EUA amendments for the inclusion of additional reagents, saliva collection kits and laboratory equipment.

As required by federal law, the SalivaDirect team routinely collects, analyzes, and submits test-related data from all labs in the network to maintain compliance with its FDA EUA. This bi-monthly regulatory process has further refined the dozens of independent laboratories into an efficient network whose main objective is to provide wide access to low-cost and widely accessible COVID-19 tests. Dynamic communications also occur through bi-weekly video meetings, Google group emails, a newsletter, and other direct correspondence.

“All of our lab partners have played a vital role in SalivaDirect’s past and present. I am honored to call them colleagues and inspired by their dedication to the pandemic response,” Wyllie said. “We are especially motivated by the intention of so many lab leaders to align with SalivaDirect’s goals of increasing access to equitable testing for all communities.”

SalivaDirect hopes the current period of lighter COVID-19 test demand will allow typically overworked lab professionals to come together Chicago this month for thinking, planning and preparing – especially for expected surges and new variants of SARS-CoV-2. During the two-day conference, international speakers will report on research and industry experience during the pandemic. Attendees will share their knowledge of the pandemic, participate in lively panel discussions, and discuss future needs for improving the response to large-scale infectious disease testing.

“Together we will identify new opportunities to apply saliva-based testing,” Wyllie concluded. “Furthermore, I am confident that we will learn how to continue to best support our SalivaDirect lab partners as champions of public health both in their contributions to research and health care in their communities.”

Space at this inaugural event is limited and attendees are encouraged to register early at SalivaDirect Conference.

About the SalivaDirect Initiative

SaliveDirect is an international saliva diagnostics initiative advancing its open source SARS-CoV-2 PCR testing protocol to support laboratory partners worldwide. As a non-profit organization within YSPH, the SalivaDirect initiative is dedicated to advancing the use of saliva-based testing as an easily deployable, sensitive, and patient-friendly option that improves access to affordable and equitable infectious disease diagnostics. Growing rapidly, the SalivaDirect lab network now includes more than 180 CLIA-designated labs in 41 U.S. states and territories. Collectively, the network has administered over 7.0 million SalivaDirect PCR tests to date. The SalivaDirect test has also 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 United States and around the world. SalivaDirect is also supported by 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 by the Public Health and Human 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 the SalivaDirect EUA Designation

Laboratories wishing to obtain official designation to administer the open source SalivaDirect SARS-CoV-2 PCR protocol should visit the Designation process page on SalivaDirect.org. By filling out this Laboratory authorization request form, laboratories can start the designation process today. With all the necessary documentation in hand, many labs complete this process in three to four business days.

Important regulatory information

SalivaDirect has not been cleared or approved by the FDA, but is cleared for emergency use by the FDA under an EUA for use by licensed laboratories. SalivaDirect has been licensed only for the detection of the SARS-CoV-2 nucleic acid form, and not for other viruses or pathogens. Emergency use of this test is authorized only for the duration of the declaration that there are circumstances justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID -19 under section 564(b)(1) of the Federal Act. Food, Drug and Cosmetic Act, 21 USC § 360bbb-3(b)(1), unless authorization is revoked earlier.

About Yale School of Public Health

Founded in 1915 as one of the first schools of public health in United Statesthe Yale School of Public Health (YSPH) is consistently ranked among the top public health schools in the nation. A CEPH-certified school of public health, YSPH is at the forefront of advancing education, science, and public health for the 21st century. The school has a long history of leadership in responses to emerging infectious diseases: contributing to the development of a vaccine against poliomyelitis in the 1960s, the fight against arboviruses such as dengue fever in the 1980s, HIV/AIDS in the 1990s, the outbreaks of Ebola, Zika and more recently COVID-19[FEMININE[FEMININE

SOURCE The SalivaDirect initiative, Yale School of Public Health

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