Quest Diagnostics Inc. announced the CE mark and European availability 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, PhD, 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."

"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, MD, 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."

-Richard Park