ProPhase Labs Begins Advanced, Saliva-based Viral PCR Multiplex-Testing for COVID-19, Influenza A & B, and Other Viruses After FDA Confirmation of Two Emergency Use Authorizations

Company Integrates Spectrum Solutions SDNA-1000 Saliva Collection System for Advanced, Simultaneous Multi-Viral Detection of Infections and Viral Mutations

GARDEN CITY, NY, Feb. 09, 2021 (GLOBE NEWSWIRE) -- ProPhase Labs, Inc. (NASDAQ: PRPH), a diversified 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 additionally 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.

Spectrum Solutions, innovative medical device manufacturer and industry leader in bio-sample collection devices, helped secure the FDA’s very first saliva-based testing EUA and continues to lead the charge in saliva-based molecular diagnostic solutions and research. 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, 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.