Garden City, N.Y.-based ProPhase Labs said in a news release that it filed for FDA emergency use authorization for its two new testing methodologies, which integrate the Spectrum Solutions saliva self-collection system with a new multiplex qPCR platform for simultaneous RNA detection of SARS-CoV-2, COVID-19 viral mutations, Influenza A, B and more.
The SDNA Viral saliva-based testing combination offers pain-free self-collection, 100% in-device viral neutralization, the removal of the need for cold-chain storage of samples and overall consistency and accuracy, ProPhase Labs said.
Spectrum Solutions developed the first saliva-based COVID-19 test to garner FDA EUA in April, working in tandem with Accurate Diagnostics Labs and Rutgers University’s RUCDR.
“We are privileged to be working with Spectrum Solutions, one of the leading life-science companies in the world on innovative testing solutions for detecting dangerous viruses including COVID-19,” ProPhase Labs CEO Ted Karkus said in the release. “This collection device and multiplex testing methodology deliver significant value to testing that other platforms have missed. Not only does our methodology identify the original COVID-19 virus, our assay also has the multiplex capability of identifying Covid-19 viral mutations.
“With the FDA deciding to limit its review of EUA submissions for COVID-19 laboratory-developed tests, receiving confirmation of a formal review from the FDA device division is a great win for all of us. Our new state-of-the-art molecular diagnostic testing equipment from Thermo Fisher not only streamlines testing results but prepares us for additional testing capabilities moving forward.”