First home-collected saliva sample kit for COVID-19 testing gets FDA nod

Users will now be able to collect a sample at home and send it to the lab in a sealed package.
By Laura Lovett
04:03 pm
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Just a few hours ago the FDA greenlighted the first home-collected saliva sample for COVID-19. Rutgers Clinical Genomics Laboratory, which already landed an EUA in mid-April for its test, can now expand its efforts to include test kits for home collection.

Patients do so using a specially designed collection device. This sample is then sent off to the Rutgers Clinical Genomics Laboratory in a sealed package. 

“Authorizing additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for COVID-19. This provides an additional option for the easy, safe and convenient collection of samples required for testing without traveling to a doctor’s office, hospital or testing site,” FDA Commissioner Dr. Stephen M. Hahn, said in a release. “We will continue to work around the clock to support the development of accurate and reliable tests, as we have done throughout this pandemic. The FDA has authorized more than 80 COVID-19 tests and adding more options for at-home sample collection is an important advancement in diagnostic testing during this public health emergency.”

This comes less than a month after the FDA granted LabCorp an EUA for its COVID-19 RT-PCR test, which lets patients collect at-home sample collection using Q-tip-style nasal cotton swabs and saline. Users would then send this sample off to a lab for testing. 

WHY IT MATTERS 

Today the U.S. has the most coronavirus cases in the world, totaling more than 1.2 million, according to the World Health Organization. Medical workers and public health officials have pushed for more testing. This morning CNN reported that Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said the U.S. needs to double its testing efforts. 

EUAs have meant that more and more testing kits are getting on the market. This latest development is yet another move to increase the convenience and availability of testing in the U.S. 

THE LARGER TREND 

Coronavirus home-testing and sample-collecting kits have had a rocky road. In mid-March a slew of companies announced home sample-collecting services for molecular testing. 

Shortly after, these companies were told to pump the brakes when the FDA clarified its policy and warned consumers that no such tests had yet been authorized. Several of these companies said that the FDA’s guidelines were ambiguous, but still pulled their product offerings and worked on adjusting them to meet the guidelines.