Tempus, a leader in artificial intelligence and precision medicine, and the Yale School of Public Health announced a research collaboration to accelerate the development of COVID-19 diagnostic tests in the U.S. This partnership will leverage SalivaDirectTM, a saliva-based laboratory diagnostic test that has been developed by researchers at Yale.
Tempus and Yale will further develop SalivaDirectTM to enable home sample collection and to combine COVID-19 and influenza testing of saliva samples. Simple and affordable at-home sample collection is seen as instrumental to providing Americans with more testing options to reduce the spread of COVID-19. Testing for both the novel coronavirus and influenza from the same sample has been described as a key priority to reduce the impact of both diseases during winter months.
“Expanded at-home testing is critical to help control the pandemic and reduce future waves of COVID-19 infection,” said Joel Dudley, PhD, Chief Scientific Officer of Tempus. “We are excited to work with leading researchers at Yale to accelerate innovation and bring new testing options to clinicians and patients.”
“This collaboration furthers our mission of leveraging scientific innovation to provide affordable COVID-19 testing throughout the country,” said Anne Wyllie, associate research scientist at the Yale School of Public Health. “Working with Tempus will allow us to conduct critical research and develop more testing options.”
SalivaDirectTM received an Emergency Use Authorization from the FDA in August for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva collected without preservatives in a sterile container from individuals suspected of COVID-19 by their healthcare provider, and the future iterations of SalivaDirectTM that Tempus and Yale are developing are expected to be subject to FDA review. To learn more about the Tempus’ COVID-19 testing, visit www.tempus.com/infectiousdiseases.
Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world’s largest libraries of clinical and molecular data, and an operating system to make that data accessible and useful, Tempus enables physicians to make real-time, data-driven decisions to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit tempus.com.
SalivaDirect™ is a qualitative test for the detection of nucleic acid from SARS-CoV-2 in saliva collected without preservatives in a sterile container from individuals suspected of COVID-19 by their healthcare provider.
SalivaDirect™ was developed by the Yale School of Public Health (YSPH) and has received an Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA). The FDA limits the emergency use of SalivaDirect™ testing only to high-complexity CLIA-certified laboratories formally designated as authorized laboratories by YSPH under the EUA 202097.
The FDA has authorized SalivaDirectTM for use by designated authorized laboratories under its emergency use authority. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, and not for any other viruses or pathogens. The SalivaDirectTM test has not been FDA cleared or approved. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. For more information, visit https://publichealth.yale.edu/salivadirect.