SalivaDirect™

COVID-19 Diagnostic Test

Psomagen, Inc. has been authorized to offer the SalivaDirect™ COVID-19 diagnostic test, developed by the Yale School of Public Health (YSPH). This test has received Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA).

ABOUT THE SALIVADIRECT™ TEST

In an effort to slow the spread of COVID-19, Yale University has developed the SalivaDirect™ test. The test was created to improve the speed, ease, and cost of detection. The testing process involves a new method for processing saliva samples, known as the RT-qPCR method, which quickly detects the presence of SARS-CoV-2. Unlike other methods, there is no requirement for a separate nucleic acid extraction step. Without such, the risk of supply shortages is minimized, while saving on time and cost.

Under the supervision of a medical professional, SalivaDirect™ allows an individual to collect their own saliva sample without swabs or other collection devices. Unlike the nasal swab, this non-invasive and pain-free test encourages a greater number of people to get tested.

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THE SALIVADIRECT™ TEST BENEFITS

  • COVID-19 test with FDA Emergency Use Authorization
  • Non-invasive and pain-free testing, encouraging a greater number of tests
  • Saves on time and cost without the requirement of a separate nucleic acid extraction step

COVID-19 Testing Industry Consortium

Psomagen was also recently accepted to join the COVID-19 Testing Industry Consortium led by Bristol Myers Squibb and other leading health care companies. The aim of the consortium is to work collaboratively to improve, innovate, and accelerate all aspects of testing, including research, regulatory oversight, clinical implications, reliability, and access. The ultimate goal of this group is to improve the impact of COVID-19 testing across the globe.

In addition to SalivaDirect™, Psomagen also offers the Psoma COVID-19 RT Test, which uses RT-qPCR to detect the SARS-CoV-2 virus in nasopharyngeal, oropharyngeal, and nasal swabs. The FDA granted the Psoma COVID-19 RT Test its Emergency Use Authorization in June 2020.   

Please note that SalivaDirect™ and Psoma COVID-19 RT Test have not been approved by the FDA and have been authorized only for the detection of nucleic acids from SARS-CoV-2 — not for other viruses or pathogens. Its use will continue only as long as the need for emergency COVID-19 diagnostic testing exists under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Request more information on the SalivaDirect™ test.