The SalivaDirect is allowed for use at limited laboratories, designated by the Yale School of Public Health
Psomagen, a CLIA-certified and CAP-accredited laboratory, has obtained the regulatory authorisation to provide Yale University SalivaDirect Covid-19 diagnostic test.
The test developed by the Yale School of Public Health (YSPH) was granted the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) in August this year.
The SalivaDirect is allowed for use at limited laboratories, designated by the Yale School of Public Health, after passing their proficiency testing.
Psomagen said the easy-to-use Covid-19 test is a welcome addition to its current diagnostic test offerings for academic, pharmaceutical, biotech, and diagnostics fields.
Psomagen CEO Ryan Kim said: “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.
“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.”
SalivaDirect deploys RT-qPCR for processing saliva samples
Yale University has developed the SalivaDirect test to contain the spread of Covid-19 and enhance the throughput, ease, and cost of detection.
The test deploys a novel method, RT-qPCR, for processing saliva samples, which helps in rapid detection of the presence of SARS-CoV-2, and prevents a separate nucleic acid extraction step, which saves time and cost.
SalivaDirect enables individuals to self-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.
Psomagen offers genomic laboratory services and comprehensive solutions for its scientific partners in the academic, pharmaceutical, biotech, and diagnostics fields.
In addition to SalivaDirect, Psomagen also offers the Psoma Covid-19 RT Test, which leverages RT-qPCR to detect the SARS-CoV-2 virus in nasopharyngeal, oropharyngeal, and nasal swabs.
The Psoma Covid-19 RT Test has been granted the FDA its Emergency Use Authorisation in June 2020.
The company noted that SalivaDirect and Psoma Covid-19 RT Test have not received the FDA approval, but authorised only for the detection of nucleic acids from SARS-CoV-2 among other viruses or pathogens.