FDA gives emergency approval to ‘game changer’ COVID-19 saliva test

FDA gives emergency approval to ‘game changer’ COVID-19 saliva test

The Food and Drug Administration gave emergency approval Saturday to a saliva test for COVID-19 that doesn’t require swabs or chemicals that have been prone to shortages, alleviating the strain on diagnostic capacity the U.S. fights the deadly pandemic.

SalivaDirect was developed by the Yale School of Public Health in partnership with a program that tests players in the National Basketball Association. It costs no more than $4 to run and can produce results within hours.

Researchers said the test is “highly sensitive” and yields similar results to those requiring a swab, which can be uncomfortable, and doesn’t require separate nucleic acid extraction step, which has led to kit shortages in the past.

Yale isn’t looking to make money off the test. It is providing the test as an “open protocol” that uses a variety of commercially available testing components, so labs across the country will be able to conduct tests by getting the instructions from Yale and following the FDA’s emergency-use authorization rules.

“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 Admiral Brett P. Giroir, the U.S. coronavirus testing “czar.”

The nation has clamored for cheap, easy-to-use tests to figure out who is spreading the disease and isolate them from society.

While the current testing regime is gradually improving, people seeking tests from commercial labs have reported lengthy turnaround times of multiple days, reducing the diagnostics’ usefulness as a public health tool.

The National Institutes of Health is supporting innovative test developers through a program known as “RADx.” It seeks to offer rapid, easy-to-use tests this fall, as schools seek better options and Americans wonder about household use.

It’s unclear how many labs will adopt the Yale test, or how quickly, but researchers said they were excited about the possibilities.

“This is a huge step forward to make testing more accessible,” said Chantal Vogels, a Yale postdoctoral fellow, who led the lab work and test-validation with Doug Brackney, an adjunct assistant clinical professor. “This started off as an idea in our lab soon after we found saliva to be a promising sample type of the detection of [the coronavirus], 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.”

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