Coronavirus Sample Saliva Test Gets FDA Approval
The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Rutgers’ RUCDR Infinite Biologics and its collaborators for a new collection approach that utilizes saliva as the primary test biomaterial to detect the SARS-CoV-2 coronavirus.
Saliva testing will help mitigate the shortage of swabs for sampling, increase the number of people tested, and will reduce the risk for healthcare professionals when collecting test samples, said this Rutgers statement.
Announced on April 13, 2020, this is the first such approval granted by the FDA and will enable broader population screening than the current method of nose and throat swabs.
“The impact of this approval is significant,” said Andrew Brooks, chief operating officer and director of technology development at RUCDR, in a related press statement.
“It means we no longer have to put healthcare professionals at risk for infection by performing nasopharyngeal or oropharyngeal collections.”
“We can preserve precious personal protective equipment for use in patient care instead of testing.”
“We can significantly increase the number of people tested each and every day as self-collection of saliva is more quick and scalable than swab collections.”
“All of this combined will have a tremendous impact on testing in New Jersey and across the United States.”
Soon after the Rutgers-ADL team received notification from the FDA on April 11th, the White House’s COVID-19 testing task force called Brooks to offer congratulations and support and to ask about any specific hurdles to expanding testing and enabling other laboratories to benefit from the accomplishment.
Shortly after the White House call, the research team was contacted by chief executive officers of some of the world’s largest life sciences companies that are involved in COVID-19 testing.
“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.
“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.”
The FDA’s approval of the new saliva testing approach is the 2nd major announcement in recent days from RUCDR, which launched a genetic testing service for the coronavirus that can test thousands of samples daily.
With the new saliva test, that number may increase to tens of thousands of samples daily.
The tests are available to the RWJBarnabas Health network, which has partnered with Rutgers University and is New Jersey’s most comprehensive health care system, including Robert Wood Johnson University Hospital, University Hospital in Newark and many other facilities, including several county health departments.
Starting April 15th, Rutgers, in partnership with the Middlesex County government and RWJBarnabas Health, will make the test available to county residents at a drive-thru testing facility in Edison, New Jersey.
RUCDR Infinite Biologics, which is part of Rutgers’ Human Genetics Institute of New Jersey, is the world’s largest university-based cell and DNA repository. Its mission is to understand the genetic causes of common, complex diseases and to discover diagnoses, treatments and cures for them.
The organization collaborates with researchers in the public and private sectors throughout the world, providing the highest quality bio-banking services and biomaterials, as well as scientific and technical support.
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