United States FDA Issues Emergency Authorization For Saliva COVID-19 Test Funded By NBA

SALT LAKE CITY, Utah – The United States Food and Drug Administration issued an emergency use authorization for a saliva COVID-19 diagnostic test funded by the NBA and the league’s Players Association.

The U.S. FDA announced the news on Saturday, August 15.

“Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 infection,” the organization said in a statement.

ESPN reported that the test is intended for “widespread public screening.”

Today, we issued an emergency use authorization to @Yale for its SalivaDirect #COVID19 diagnostic test, which uses a new method of processing saliva samples. This is the 5th test FDA has authorized using saliva as a sample for testing. https://t.co/UpmAA4Kl3l pic.twitter.com/GYeX5XZD28

— U.S. FDA (@US_FDA) August 15, 2020

“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,” said Assistant Secretary for Health and COVID-19 Testing Coordinator Admiral Brett P. Giroir, M.D. “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 cost per sample could be as low as about $4, though the cost to consumers will likely be higher than that — perhaps around $15 or $20 in some cases,” sources told ESPN.

BREAKING: Great news.

SalivaDirect received approval this morning from the @US_FDA.

This could be one the first major game changers in fighting the pandemic. Rarely am I this enthusiastic. Here’s why.

Follow if interested.

— Andy Slavitt @ 🏡 (@ASlavitt) August 15, 2020

“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,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s 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.”

The FDA just authorized a saliva test for COVID-19 created by Yale and funded by the NBA and @TheNBPA. How that partnership came to be, and how the test works https://t.co/Vb5jIHU0uI

— Zach Lowe (@ZachLowe_NBA) August 15, 2020

The SalivaDirect test requires a saliva sample to be collected in a sterile container as opposed to other COVID-19 tests which require methods like a special type of swab.

The FBA said “this is significant because the extraction kits used for this step in other tests have been prone to shortages in the past.”

This is the fifth test that the FDA has authorized that uses saliva as a sample for testing.