FDA authorizes use of COVID-19 saliva test funded by NBA
The FDA issued an emergency use authorization to the Yale School of Public Health for a saliva-based COVID-19 diagnostic test, making the test available to any laboratory that wants to use it.
The SalivaDirect test, which uses a novel method of processing saliva samples, was developed with funding from the NBA. Researchers are further validating it as a COVID-19 test for asymptomatic people through a program that tests players and staff from the NBA, Yale said.
“The SalivaDirect test for rapid detection of SARS-CoV-2 is yet another testing innovation game-changer that will reduce the demand for scarce testing resources,” Adm. Brett P. Giroir, MD, assistant secretary for health and COVID-19 testing coordinator for HHS, said in a press release. “Our current national expansion of COVID-19 testing is only possible because of FDA’s technical expertise and reduction of regulatory barriers, coupled with the private sector’s ability to innovate and their high motivation to answer complex challenges posed by this pandemic.”
The FDA previously authorized an at-home saliva diagnostic test for COVID-19 in May.
The newly authorized saliva-based test allows for saliva samples to be collected in any form of sterile container, and does not require nucleic acid extraction. The test has been authorized and validated for use with common reagents. Yale will provide the test’s protocol to any interested laboratory that can obtain the necessary components and analyze the results.
“Providing this type of flexibility for processing saliva samples to test for COVID-19 infection is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents,” FDA Commissioner Stephen M. Hahn, MD, said in the release. “[This] authorization is another example of the FDA working with test developers to bring the most innovative technology to market in an effort to ensure access to testing for all people in America. The FDA encourages test developers to work with the agency to create innovative, effective products to help address the COVID-19 pandemic and to increase capacity and efficiency in testing.”
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