Draper-based Spectrum Solutions LLC has been granted FDA emergency use authorization (EUA) approval for the immediate use of saliva in COVID-19 testing using the company’s Spectrum SDNA-1000 saliva collection device. The Spectrum device protects and preserves RNA used for the detection of infection.
The issued EUA for saliva as a viable biosample in COVID-19 testing came from the result of a detailed saliva versus swab study strategically looking for an answer to the swab and media supply shortages felt not only nationwide but globally, Spectrum said in a release. The study conclusion uncovered a novel and technically robust testing alternative using saliva collected with the Spectum saliva collection device. These results fast-tracked EUA approval for the samples collected with the Spectrum device to be tested by the RUCDR Infinite Biologics and Rutgers Clinical Genomics Laboratory and its Perkin Elmer nucleic acid extraction as well as the ThermoFisher TaqPath SARS-CoV-2 automated processes, the company said.
“Using saliva to test for COVID-19 overcomes many of the challenges the nation faces that are inherent to current testing methods including supply shortages and risks to exposure for healthcare professionals,” said Stephen Fanning, CEO of Spectrum Solutions. “Now, under a medical professional’s direction, the saliva collection can be self-administered by individuals who may be in quarantine or self-isolation, removing the need to be in close contact with medical staff.”
