The winners of Fast Company’s 2022 World Changing Ideas Awards were announced today, honoring clean technology, innovative corporate initiatives, brave new designs for cities and buildings, and other creative works that are supporting the growth of positive social innovation, tackling social inequality, climate change, and public health crises. This year, the SalivaDirect Initiative at the Yale School of Public Health was named a finalist in the Pandemic Response category. What began as a desire to mitigate COVID-19 testing challenges and supply shortages evolved into a reliable, affordable, streamlined, saliva-based PCR test and the broader SalivaDirect International Saliva Diagnostics Network of laboratories.
“While I had worked with saliva as a sample type throughout my career, I certainly didn't expect it to play such a prominent role in the pandemic response. It’s an honor for SalivaDirect to be included on such a prestigious list by Fast Company,” said Yale Research Scientist Anne Wyllie, Ph.D., principal investigator for the SalivaDirect Initiative. “Our team worked tirelessly to develop and broadly deploy an additional type of COVID-19 PCR test, free from the supply chain issues and patient challenges initially limiting nasopharyngeal swabs.”
Pioneered by Wyllie and her colleagues at the Yale School of Public Health, SalivaDirect is an open-source PCR test that readily detects SARS-CoV-2 in saliva. Purpose-built to run with many commonly available reagents and PCR equipment, laboratories are able to utilize existing infrastructure and vendor relationships rather than source often costly specialty materials. Eliminating the costly extraction step of the PCR process helps labs speed throughput, lower operational costs, and importantly, provide same-day test PCR results. Innovating with the U.S. FDA, SalivaDirect received a unique umbrella Emergency Use Authorization that it could extend to eligible labs across the country, allowing many to start testing more quickly, and minimizing regulatory agency bottlenecks. For patients, giving a saliva sample is non-invasive and pain-free—they can do it themselves, increasing the potential for higher testing compliance while reducing the risk of transmission to healthcare workers.
Uniquely, SalivaDirect is the first-ever open-source, non-proprietary diagnostic testing protocol authorized by the U.S. FDA. Using an open-source distribution model allowed SalivaDirect to reach pandemic front lines efficiently, effectively, and fast. Most diagnostic tests on the market are proprietary which can drive up costs exorbitantly as industry test developers seek to recuperate costs of R&D and earn investor-driven profits.
“Frequent, high-quality testing is essential to protect our communities from the evolving COVID-19 pandemic,” said Wyllie. “We designed the SalivaDirect COVID-19 PCR test to be readily scalable and easy for labs to deploy; painless and simple for patients; capable of returning same-day results; and cost-effective. Because of this, SalivaDirect enables rapid setup of affordable, high-quality testing programs for all communities in need.”