The world's leading provider of diagnostic testing, Quest Diagnostics Incorporated, announced the CE mark and European launching of the Simplexa Flu A/B & RSV Direct test on the 3M Integrated Cycler. The new test, from the company's Focus Diagnostics business, uses a proprietary technique to eliminate nucleic-acid sample extraction, a time-consuming process required by other molecular test products, for faster results reporting.

"Simplexa Direct chemistry employs a novel technology that overcomes a critical limitation found in most molecular test kits on the market: the need for extraction of nucleic acids," said Maurice Exner, Ph.D., vice president of research and development, Focus Diagnostics. "With this advance, molecular testing will be far easier and faster for labs to perform than before. We believe the Simplexa Direct method is an important step toward enabling a greater range of healthcare professionals to access quality molecular testing. We look forward to introducing our first Simplexa Direct product, for influenza and respiratory syncytial virus testing, to laboratories in Europe."

Nucleic-acid extraction is a process requiring specialized molecular equipment and trained personnel. It involves extracting DNA or RNA from a blood, plasma or other specimen type for testing. The nucleic-acid extraction process, used in most commercial molecular test kits, can add approximately 60 to 90 minutes to total testing time. Focus Diagnostics has replaced the process with a proprietary reaction-mix technique. The company expects to use the proprietary technology in future Simplexa products.

Simplexa Flu A/B & RSV Direct is an addition to the influenza and respiratory franchise of award-winning FDA-cleared and CE-marked assays available through Focus Diagnostics.

"The future of influenza testing and, indeed, all respiratory virus testing is molecular. This is because molecular testing offers the potential to provide both high sensitivity and faster turnaround time. Clinicians need an accurate result in a timely manner to help them make the best management decisions for their patients," said Jay M. Lieberman, M.D., medical director, infectious disease, for Quest Diagnostics and Focus Diagnostics. "As technology continues to evolve, molecular testing will become easier and more accessible to a great number of labs and physicians."

Focus Diagnostics, a wholly-owned business of Quest Diagnostics, develops and manufactures the Simplexa line of molecular test products operating on the 3M Integrated Cycler, a compact, portable testing platform, as part of an exclusive global collaboration with 3M. Simplexa was the first test kit to be FDA cleared for aiding in the detection and differentiation of the 2009 H1N1 influenza virus, in May 2010. Additional FDA-cleared Simplexa tests aid the detection of influenza A and B and respiratory syncytial virus. Several other Simplexa-branded tests, including for Clostridium difficile, Epstein Barr and BK viruses, are CE marked and distributed in Europe. In 2011, the Simplexa/3M technology won a gold Medical Design Excellence Award in the in vitro diagnostics category and an Edison Award for new science and medical diagnostic product.