Emergency use authorization granted for new biomaterial collection approach
The 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 for the SARS-CoV-2 coronavirus, the first such approval granted by the federal agency.
The new saliva collection method, which RUCDR developed in partnership with Spectrum Solutions and Accurate Diagnostic Labs (ADL), will allow for 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, who also is a professor in the School of Arts and Sciences Department of Genetics at Rutgers University–New Brunswick. “It means we no longer have to put health care 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 Saturday, 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.”
Rutgers University President Robert Barchi called the new saliva test a “herculean effort that is great for the country and the world and by reflection great for our university.”
“Saliva testing will help with the global shortage of swabs for sampling and increase testing of patients, and it will not require health care professionals to be put at risk to collect samples,” Brooks said. “Saliva testing will also be important for people who are in quarantine because they don’t know how long it will be until they are no longer infectious. This will allow health care workers to release themselves from quarantine and safely come back to work.”
“The test can help hospital-based and private physicians to accurately assess the infection status of more patients, with RUCDR Infinite Biologics doing the analysis,” said Jay A. Tischfield, the founder, chief executive officer and scientific director of RUCDR and a Distinguished Professor also in the Department of Genetics at Rutgers–New Brunswick and at Rutgers Robert Wood Johnson Medical School.
“Rutgers is proud to be on the cutting edge of the fight against the COVID-19 pandemic,” said Rutgers Biomedical and Health Sciences Chancellor Brian Strom. “We have long said our researchers and health care employees are working to help make the world well, but never has it been more true than now.”
Rutgers University–New Brunswick Chancellor Chris Molloy agrees. “Rutgers has always been on the leading edge of research and discovery. We are proud of the work we do and the positive impact it has on the world.”
The FDA’s approval of the new saliva testing approach is the second 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 Wednesday, 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 at 33 Kilmer Road, Edison, New Jersey.
ABOUT RUCDR INFINITE BIOLOGICS
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
ABOUT SPECTRUM SOLUTIONS AND SPECTRUM DNA
Headquartered in Salt Lake City, Utah, Spectrum Solutions and its medical device and services division, Spectrum DNA, focus on innovative, end-to-end product development, manufacturing, and global fulfillment solutions. With concentrated industry expertise, Spectrum DNA specializes in engineering innovative molecular diagnostic solutions that simplify the biosample collection process while offering donors complete physical and digital chain-of-custody. With on-site production facilities, we are a single-source provider of full-service medical device manufacturing, custom and private label packaging, kitting, and direct-to-donor global fulfillment. Our new biosample collection devices, patented technology, and services provide measurable process optimization, unprecedented efficiency, and unmatched global scalability. For more information, please visit www.spectrum-dna.com.
ABOUT ACCURATE DIAGNOSTIC LABS
Accurate Diagnostic Labs is one of the largest privately held, boutique, full-service clinical laboratories in the country. ADL, as a full-service core laboratory, proudly works with various entities on laboratory testing for clinical trial drug development and data repository in various market footprints to progress the field of disease state management and personalized medicine. With our local headquarters based in Central New Jersey, we pride ourselves in working with various healthcare corporations, institutions, health systems, and the local providers in the metropolitan area with the common goal of improving local and national healthcare. For more information on ADL, please call at 732-839-3300 or visit online at www.accuratediagnosticlabs.com.