FDA Grants Emergency Use Authorization to Saliva-Based COVID-19 Test

The FDA has granted emergency use authorization (EUA) to a saliva-based laboratory diagnostic test for coronavirus disease 2019 (COVID-19).

The test, called SalivaDirect, was developed by researchers at the Yale School of Public Health and is currently in use to evaluate asymptomatic individuals through a COVID-19 testing program of players and staff from the National Basketball Association. The SalivaDirect test is easier to use, less expensive, and less invasive than the nasopharyngeal (NP) swabbing method for COVID-19, with results suggesting that SalivaDirect is highly sensitive and yields similar outcomes as NP swabbing, according to a Yale press release.

“This is a huge step forward to make testing more accessible,” Chantal Vogels, a Yale postdoctoral fellow who co-led the laboratory development and validation, said in the press 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.”

Following the EUA, SalivaDirect is now available to other diagnostic laboratories and its production can be scaled up quickly for widespread use, according to the researchers. They added that because the test was validated with reagents and instruments from multiple vendors, this provides flexibility to provide continued testing if any vendors deal with the supply chain challenges seen early in the COVID-19 pandemic.

The researchers said that the SalivaDirect test was designed to eliminate the need for costly saliva collection tubes used by other companies to preserve the virus for detection. They noted a separate study conducted at the Yale School of Public Health that found severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, is stable in saliva for prolonged periods at warm temperatures and that preservatives or specialized tubes are not necessary for collection.

Yale also announced a partnership with Jackson Laboratory for Genomic Medicine in Farmington, Connecticut, to explore implementing the test for a broader audience, noting that the laboratory already analyzes patient samples for an RNA signature unique to SARS-CoV-2.

“Widespread testing is critical for our control efforts. 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,” said researcher Nathan Grubaugh, assistant professor at Yale School of Public Health. “If cheap alternatives like SalivaDirect can be implemented across the country, we may finally get a handle on this pandemic, even before a vaccine.”

On CNBC this morning, former FDA Commissioner Scott Gottlieb, MD, called the SalivaDirect test “highly significant,” adding that it could improve COVID-19 testing in the United States.

“It’s also been cross validated on just about every popular platform for doing testing,” Gottlieb told CNBC. “So, it’s easy to use. It’s unlikely to be in limited because of shortages in the testing supply chain.” He added, “It’s something that we can roll out on a very wide fashion.”

Reference

Quick and affordable saliva-based COVID-19 test developed by Yale scientists receives FDA Emergency Use Authorization. Yale News. https://news.yale.edu/2020/08/15/yales-rapid-covid-19-saliva-test-receives-fda-emergency-use-authorization. Published August 15, 2020.