Rutgers University Saliva Test for COVID-19 Receives FDA Approval

A new test developed for the coronavirus disease 2019 (COVID-19) that uses saliva has been approved by the FDA, according to Rutgers University.¹

This is the first approval of a test that uses saliva as the primary test biomaterial for the severe acute respiratory syndrome coronavirus (SARS-CoV-2).¹

Launched by Rutgers’ RUCDR Infinite Biologics, the test uses its automation experience and infrastructure to test as many as 1000 samples a day.²

The test is available to the RWJ Barnabas Health network and was rapidly deployed throughout the state through the partnership of RUCDR and Accurate Diagnostic Labs. This alternate collection option will help catapult access of testing and screening to the most needed populations, according to RUCDR.²

“The impact of this approval is significant,” said Andrew Brooks, chief operating officer and director of technology development at RUCDR, in a university press release. “It means we no longer have to put health care professionals at risk for infection by performing nasopharyngeal or oropharyngeal collections.”¹

In addition, Brooks said in the press release that it is now easier to preserve personal protective equipment for use in patient care instead of testing.¹

According to Brooks, the White House’s COVID-19 testing task force called to offer congratulations and asked about any specific hurdles to expanding the test and enabling other laboratories to benefit from the accomplishment.¹

“I have spoken with these companies’ leadership to not only share knowledge but to create opportunities for continuing to help innovate during this crisis,” Brooks said in a university press release. “We will work closely with these new partners, the FDA and the White House task force to leverage everything Rutgers has to offer to not only help our community but also make a global impact.”¹

REFERENCES

• New Rutgers saliva test for coronavirus gets FDA approval. RutgersToday. https://www.rutgers.edu/news/new-rutgers-saliva-test-coronavirus-gets-fda-approval. Published April 13, 2020. Accessed April 13, 2020.
• Murphy, Jill. Rutgers launches new genetic testing service for COVID-19. Pharmacy Times. https://www.pharmacytimes.com/news/rutgers-launches-new-genetic-testing-service-for-covid-19. Published April 3, 2020. Accessed April 13, 2020.