ProPhase Labs, Garden City, NY, has begun new saliva-based, viral RT-PCR multiplex-testing as a laboratory developed test (LDT) classification. Emergency use authorization (EUA) applications have been filed and confirmed by the FDA for its two new testing methodologies. Testing integrates the Spectrum Solutions saliva self-collection system with a new, advanced multiplex qPCR platform for the simultaneous RNA detection of not only SARS-CoV-2 (covid-19) but also covid-19 viral mutations, as well as Influenza A, B, and more.
This new SDNA Viral saliva-based testing combo features pain-free self-collection and 100% in-device viral neutralization, removes the need for cold-chain storage of samples, and provides critical sample consistency for optimal accuracy. It additionally offers patients an intuitive and safe sample collection process while delivering the most robust testing biomaterial for the detection of multiple viral infections or mutations in a single test.
Spectrum Solutions, a Salt Lake City, Utah-based medical device manufacturer and a leader in bio-sample collection devices, helped secure the FDA’s very first saliva-based testing EUA and continues to develop saliva-based molecular diagnostic solutions. This new, efficient, and cost-effective multi-viral testing product has been engineered to increase testing accuracy and overcome the challenges of limited samples and costly analysis.
This testing provides patients an immediate diagnostic advantage using a single saliva test to quickly detect and identify covid-19, any of its 17+ current viral mutations, including those first reported in the United Kingdom and now found throughout the United States as well as Influenza A and B. With test processing already underway at both ProPhase New York and New Jersey CLIA certified lab locations, the company says this new technology ensures optimal assay reliability, offers numerous diagnostic advantages over other testing applications, and delivers the capacity to process more than 60,000 tests per day.
“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,” says Ted Karkus, CEO of ProPhase Labs. “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.”For more information, visit spectrumsolution.com/SDNA and ProPhase Labs.
Featured image: Spectrum Solutions SDNA-1000 Only EUA Approved Saliva Collection Device for COVID-19 Testing (Courtesy: Spectrum Solutions)