FDA granted 510(k) clearance and CLIA moderate-complexity categorization approval for Focus Diagnostics’ Simplexa Flu A/B & RSV Direct test on the 3M™ Integrated Cycler. The assay, developed jointly by Focus and 3M with $5.9 million of Biomedical Advanced Research and Development Authority (BARDA) funding, is designed to aid in the qualitative detection and differentiation of influenza A and B virus RNA, and respiratory syncytial virus (RSV). It requires no nucleic acid extraction procedure and generates results within an hour. A CE mark was granted in 2011.
Focus (a subsidiary of Quest Diagnostics) says the Simplexa Flu A/B & RSV Direct test is the first moderate-complexity molecular assay in its Simplexa product line. CLIA-defined moderate complexity laboratories include certain types of doctor’s offices, community hospitals, health clinics, and integrated delivery networks, which may lack the staff and technology to carry out high-complexity diagnostic assays.
“The future of influenza and all respiratory virus testing is molecular diagnostics, given its potential for high sensitivity and fast reporting of test results, which are essential for patient management,” comments Jay M. Lieberman, M.D., Focus and Quest’s medical director for infectious diseases. “The clearance and moderate complexity categorization of the Simplexa test on the 3M Integrated Cycler signifies an important step forward in expanding access to near-patient molecular testing.”
Focus’ Simplexa testing line for the portable 3M instrument includes assays for the H1N1 influenza virus, and for detecting and differentiating Clostridium difficile, Bordetella pertussis, and parapertussis, cytomegalovirus, Eptstein Barr virus, and BK virus. Focus also offers a potfolio of HerpeSelect® HSV type-specific serology assays, and a line of DxSelect™ IFA and ELISA kits to help diagnose diseases such as West Nile Virus, rickettsia, and legionella.