FDA Approves Saliva-Based Coronavirus Test



The U.S. Food and Drug Administration granted emergency use authorization to a saliva-based testing method for the new coronavirus, a major step that could speed up testing for cases as the country grapples with the pandemic.

The method, named SalivaDirect and developed by Yale University, is cheaper and less invasive than swab tests while maintaining effectiveness. With the authorization, it is immediately available for diagnostic laboratories to use.

“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,” Assistant Secretary for Health and COVID-19 Testing Coordinator Brett Giroir said in a statement. “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.”

SalivaDirect is just as effective as nasopharyngeal swabbing, which has so far been the go-to method for COVID-19 testing. Yale’s new method, however, does not involve sticks going up people’s noses, limits health workers’ exposure to possibly infected patients, and costs less than $5 per test. It has also been validated with components from various vendors, which should allow it to bypass any supply chain issues.

The National Basketball Association, which has restarted in Disney World in Orlando, Flordia, is using SalivaDirect in testing players and staff to ensure that the bubble remains COVID-19-free.

“With saliva being quick and easy to collect, we realized it could be a game-changer in COVID-19 diagnostics,” Yale School of Public Health associate research scientist Anne Wyllie said.

Fighting against COVID-19

Widespread COVID-19 testing is the best way to prevent the spread of the disease, according to public health experts. A mass shortage has unfortunately dampened the country’s testing abilities, but SalivaDirect may be quickly scaled up to be used across the U.S., according to a Yale statement.

Meanwhile, the whole world waits for a coronavirus vaccine, with the National Institute of Allergy and Infectious Diseases director Dr. Anthony Fauci previously saying that he was “cautiously optimistic” that a vaccine will be ready within the year.

But before that happens, enough people will need to sign up as volunteers for the trials that will be carried out by various laboratories.

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