FDA Grants Emergency Use Authorization to NBA-Funded Saliva-Based Coronavirus Test

August 18, 2020 Topic: Health Blog Brand: Coronavirus Tags: NBACoronavirusCOVID-19Health

FDA Grants Emergency Use Authorization to NBA-Funded Saliva-Based Coronavirus Test

The U.S. Food and Drug Administration has issued an emergency authorization that allows for the public use of a saliva-based test for the novel coronavirus that was developed at Yale University and funded by the National Basketball Association.

 

The U.S. Food and Drug Administration has issued an emergency authorization that allows for the public use of a saliva-based test for the novel coronavirus that was developed at Yale University and funded by the National Basketball Association.

The test, known as SalivaDirect, is designed for widespread public screening and is considered less invasive and cheaper than traditional methods like nasopharyngeal swabbing. The cost to consumers will likely range from $15 to $20.

 

Yale administered the saliva test to a group of NBA players and staff before the league’s return to action late last month.

Test results have so far indicated that SalivaDirect is highly sensitive and yields similar outcomes as nasopharyngeal swabbing. The preprint on the development and validation of SalivaDirect was recently posted on medRxiv.

“This is a huge step forward to make testing more accessible,” Chantal Vogels, a Yale postdoctoral fellow, who led the laboratory development and validation along with Doug Brackney, said in a news release.

“This started off as an idea in our lab soon after we found saliva to be a promising sample type of the detection of SARS-CoV-2, and now it has the potential to be used on a large scale to help protect public health. We are delighted to make this contribution to the fight against coronavirus.”

The development of SalivaDirect was spearheaded by Nathan Grubaugh and Anne Wyllie, assistant professor and associate research scientist, respectively, at Yale School of Public Health.

After discovering that using saliva could be a promising method in the detection of COVID-19, the duo aimed to improve on it further.

“With saliva being quick and easy to collect, we realized it could be a game-changer in COVID-19 diagnostics,” Wyllie said in a news release.

Being able to decrease both testing times and associated costs was of high priority.

“Wide-spread testing is critical for our control efforts,” Grubaugh said.

“We simplified the test so that it only costs a couple of dollars for reagents, and we expect that labs will only charge about $10 per sample. If cheap alternatives like SalivaDirect can be implemented across the country, we may finally get a handle on this pandemic, even before a vaccine.”

Most medical experts are in agreement that the shortage of testing for COVID-19 and the long delays in receiving results have been a major hurdle in the fight against the pandemic.

“We must continue to invent and implement new ways to conduct SARS-CoV-2 testing faster, more economically and with greater accessibility, while maintaining acceptable test accuracy,” Charles Lee, the director of the Jackson Laboratory for Genomic Medicine, which will partner with Yale to explore how to best implement the test for a wider population, said in a news release.

“This method is an important next step toward this goal.”

Ethen Kim Lieser is a Minneapolis-based Science and Tech Editor who has held posts at Google, The Korea Herald, Lincoln Journal Star, AsianWeek and Arirang TV. Follow or contact him on LinkedIn.