Rockville, MD, Dec. 11, 2020 (GLOBE NEWSWIRE) -- Psomagen, Inc., a CLIA-certified and CAP-accredited laboratory based in Rockville, Maryland, is pleased to announce its recent authorization to offer Yale University's SalivaDirect™ COVID-19 diagnostic test, which was developed by the Yale School of Public Health (YSPH) and received Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA) in August 2020.
The use of SalivaDirect™ is limited to laboratories designated by the Yale School of Public Health that pass their proficiency testing. This easy-to-use test will be a welcome addition to Psomagen’s current diagnostic test offerings.
About the SalivaDirect™ Test
Yale University has developed the SalivaDirect™ test in an effort to slow the spread of COVID-19 and improve the throughput, ease, and cost of detection. The testing process involves a novel method for processing saliva samples, known as the RT-qPCR method, which quickly detects the presence of SARS-CoV-2. Unlike other methods, this one does not require a separate nucleic acid extraction step, which saves time and cost while minimizing the risk of supply shortages.
“The ability to easily and more efficiently test for COVID-19 in many different specimen types is critical in how the world will manage this ongoing pandemic,” said Ryan Kim, CEO of Psomagen, Inc. “The addition of the SalivaDirect™ test to Psomagen's testing capabilities is a positive step in the direction of making testing more accessible as we witness a resurgence in COVID-19 cases in this country."
With SalivaDirect™, an individual can collect their own saliva sample in a sterile container under the supervision of a medical professional without swabs or other collection devices. Unlike the nasal swab, this test is non-invasive and pain-free, which encourages a greater number of people to get tested.
About Psomagen, Inc.
Psomagen is a leading provider of CLIA-certified and CAP-accredited genomic laboratory services. The company proudly provides comprehensive solutions for its scientific partners in the academic, pharmaceutical, biotech, and diagnostics industries. More specifically, Psomagen offers best-in-class laboratory capabilities in next-generation sequencing, Sanger sequencing, clinical sequencing, molecular diagnostics, bioinformatics, and direct-to-consumer testing with clinical, direct-to-consumer, and research applications. The company is incorporated in the United States with headquarters in Rockville, Maryland, and branch offices in Virginia, New York, and Massachusetts.
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.
Learn more at psomagen.com.
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