News Release 

Yale begins designating SalivaDirect COVID-19 test to external labs

Yale University

Science Business Announcement

New Haven, Conn. -- Yale has designated three independent laboratories to perform the university-developed SalivaDirectTM COVID-19 test. Along with Yale Pathology Labs -- the first to offer the test -- Access Medical Laboratories, Hennepin County Medical Center (HCMC), and Mirimus, Inc., represent the initial wave of providers for the innovative testing method. They will make SalivaDirectTM available to people in Florida, Minnesota and New York by late September.

SalivaDirectTM was developed by a Yale School of Public Health research team led by Nathan Grubaugh, assistant professor, and Anne Wyllie, associate research scientist. Their method is less prone to supply chain bottlenecks, more economical, and less invasive than nasopharyngeal (NP) swabbing, the most common form of testing available currently. The test received FDA Emergency Use Authorization on Aug. 15.

"After discovering saliva is a promising sample type for SARS-CoV-2 detection, we have made it our mission to develop a testing method that is accurate, affordable, and accessible to all," said Wyllie. "Our hope is that eventually every person that needs a COVID-19 test will be able to get one. Our laboratory partners are instrumental in ensuring schools and other essential institutions can remain open and healthy."

In a spring 2020 pilot program led by the Yale School of Public Health, The National Basketball Association (NBA), and the National Basketball Players Association (NBPA), SalivaDirectTM was used to successfully test asymptomatic people within the NBA. This success attracted the attention of laboratories nationwide.

"Having seen the ease and effectiveness of using SalivaDirectTM to test our players and staff for COVID-19 firsthand, I am looking forward to seeing these laboratories help us achieve the overall mission of rolling out an affordable test to the masses, especially those in our most vulnerable communities," said Robby Sikka, vice president of basketball performance and technology for the Minnesota Timberwolves. "We are proud and excited to see these labs partner with schools and other area organizations to help reduce the spread of COVID-19."

SalivaDirectTM does not require any special type of swab or collection device; a saliva sample can be collected in any sterile container. As stated by the U.S. Food and Drug Administration, "this test is also unique because it does not require a separate nucleic acid extraction step. This is significant because the extraction kits used for this step in other tests have been prone to shortages in the past. Being able to perform a test without these kits enhances the capacity for increased testing, while reducing the strain on available resources."

"We are so grateful to extend SalivaDirectTM to these laboratory partners, and because our test does not rely on any proprietary equipment it can be assembled and used in most high-complexity labs across the country. As such, our hope is that many other labs will follow suit," said Grubaugh. "While we are not looking to commercialize the method, we absolutely want it to be widely available; the only way we will see this pandemic in the rearview mirror is to increase testing in every single neighborhood across the country, regardless of economics."

High-complexity CLIA labs need to apply for designation from Yale and more information on that process can be found on the SalivaDirect website.

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FOR LABORATORY QUERIES:

* Yale Pathology Labs https://medicine.yale.edu/pathology/outreach/
Contact: Stephanie Weirsman stephanie.weirsman@yale.edu

* Access Medical Laboratories https://accessmedlab.com/
Contact: Andrew O'Connor, Teamcovid19@accessmedlab.com

* Hennepin County Medical Center https://www.hennepinhealthcare.org Contact: Glen Hansen glen.hansen@hcmed.org

* Mirimus, Inc. https://mirimus.com/
Prem Premsrirut: prem@mirimus.com; 929-377-3744

*The FDA has authorized SalivaDirect™for use by designated laboratories under its emergency use authority. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. 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.

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