FDA Approves First At-Home Saliva Test for COVID-19

With diagnostic testing being of paramount importance in the current COVID-19 pandemic, there are unanimous calls for expanded and rapid testing. To assist in, and help accelerate, these efforts, the US Food and Drug Administration (FDA) has provided emergency use authorization (EUA) for the first at-home saliva test for COVID-19.

The diagnostic’s at-home testing option will allow patients to collect saliva samples themselves and send them to a lab for testing. This can help make testing more convenient, rapid and accessible, as well as less invasive than conventional nose and throat swab collection methods.

The test was developed by RUCDR Infinite Biologics, a unit at the Rutgers Clinical Genomics Laboratory at Rutgers University, alongside collaborators Spectrum Solutions and Accurate Diagnostic Labs.

The test involves a self-collection kit that allows patients to collect saliva samples by simply spitting into a tube and returning it to the Rutgers Clinical Genomics Laboratory in a sealed package for testing.

The COVID-19 laboratory developed test (LDT) had been added to the EUA umbrella of high complexity molecular-based LDT to permit testing of samples self-collected by patients at home using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device.

Last month, an EUA was issued for the first diagnostic test with a home-collection option, but that test involves collection of nasal samples using nasopharyngeal swabs. Nevertheless, any type of a self-collection option will provide patients with an easy and convenient means for testing.

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In a press release, FDA Commissioner Dr. Stephen M. Hahn stated that, “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.”

He also emphasized the FDA’s commitment to support the development of accurate and reliable diagnostic tests for COVID-19, highlighting that, “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.”

The Rutgers test is currently the only authorized diagnostic test for COVID-19 that detects the presence of SARS-CoV-2, the strain of virus that causes COVID-19, in patients using saliva samples. The test is only available by prescription.

The saliva tests will be made available this week by Rutgers University in partnership with the RWJBarnabas Health network and Middlesex County through a drive-thru testing facility in Edison, New Jersey.

The FDA has so far worked with more than 300 test developers during the coronavirus pandemic who plan to submit EUA requests to the agency for their diagnostic tests. So far 34 EUAs have been issued for diagnostic tests to date, according to the FDA.

Accurate, reliable and timely testing is critical in controlling the current COVID-19 pandemic. The introduction of less invasive and convenient at-home testing options will help assist in these efforts through expanded widespread testing.