ProPhase Labs Inc., a medical science and technology company, 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 U.S. Food and Drug administration (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, 100% in-device viral neutralization, removes the need for cold-chain storage of samples, and provides critical sample consistency for optimal accuracy. It also offers patients the most intuitive and safest sample collection process while delivering the most robust testing biomaterial for the detection of multiple viral infections or mutations in a single test.
 
Emergency Use Authorization
Spectrum Solutions, innovative medical device manufacturer and industry leader in bio-sample collection devices, helped secure the FDA’s first saliva-based testing EUA and continues to lead the charge in saliva-based molecular diagnostic solutions and research. This new 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, this new, innovative 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,” said 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.”
 
“Testing is the purposeful pursuit of understanding a disease and a window into each individual’s personalized response,” said Bill Phillips, chief operating officer at Spectrum Solutions. "Without testing, patients and medical professionals would not be able to make informed decisions on the proper treatment path. We could not be more excited to partner with industry front-runner ProPhase Labs on the new Spectrum SDNA Viral testing solution. The industry needs more innovative testing collaborations like this, delivering real actionable insights, to help move us all forward."
 
This collaboration coupled with other technologies and innovations will continue to provide a wide range of laboratory testing services for the diagnosis, screening, and evaluation of additional diseases.