FDA grants 1st clearance of at-home saliva test for coronavirus

2020 05 08 19 58 8675 2020 05 08 Rutgers 400

The U.S. Food and Drug Administration (FDA) has granted the first clearance of an at-home saliva test for SARS-CoV-2 to Rutgers Clinical Genomics Laboratory at RUCDR Infinite Biologics.

Rutgers Clinical Genomics Laboratory secured an amended emergency use authorization (EUA) from the FDA for the laboratory-developed test. In April, the university lab had received an EUA for the saliva test, but the clearance stipulated that the collection of saliva specimens should be performed in a healthcare setting under the supervision of a trained healthcare provider.

The self-collection test, which was developed in partnership with Spectrum Solutions and Accurate Diagnostic Labs, aims to provide broader screening. Per the EUA, the saliva specimens will be collected using the Spectrum Solutions SDNA-1000 saliva collection device. Individuals will collect their samples and then send them to the laboratory for analysis.

Fully automated nucleic acid extraction workstation can process up to 10,000 saliva samples per day for SARS-CoV-2 coronavirus testing. Courtesy of Rutgers University's RUCDR Infinite Biologics. Photo: David SokolowskiFully automated nucleic acid extraction workstation can process up to 10,000 saliva samples per day for SARS-CoV-2 coronavirus testing. Courtesy of Rutgers University's RUCDR Infinite Biologics. Photo: David Sokolowski

"It is important to note that this is not a general authorization for at-home collection of patient samples using other collection methods, saliva collection devices, or tests, or for tests fully conducted at home," the FDA said in a statement on May 8 announcing the clearance.

The amended clearance for the saliva test builds on the agency's prior EUA for an at-home coronavirus diagnostic test of nasal samples developed by LabCorp.

"Authorizing additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for COVID-19," FDA Commissioner Stephen Hahn stated. "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."

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