The Brazilian authorities have cleared Quest Diagnostics’ Simplexa™ Dengue molecular test kit, which was developed by the firm’s Focus Diagnostics business. The firm claims the blood assay, which is run on the portable 3M™ Integrated Cycler, is the first commercial real-time PCR Dengue test to be approved for use by Brazil’s public and private health laboratories. The assay is designed to quantitatively detect and differentiate between the four Dengue serotypes, and provides results in about an hour following sample extraction, Quest claims.
The Simplexa test family has been developed and is manufactured by the firm’s wholly owned Focus business, through an exclusive deal with 3M. In May 2010 a Simplexa assay was the first test kit to be cleared by FDA for aiding in the detection and differentiation of the 2009 H1N1 influenza virus. Additional FDA-cleared Simplexa tests are available for detecting influenza A, influenza B, and respiratory syncytial virus. Simplexa tests for Clostridium difficile, cytomegalovirus, Epstein Barr, and BK viruses are CE marked and distributed in Europe. The Simplexa Flu A/B & RSV Direct test was granted a CE mark and launched in Europe and other countries recognizing the CE mark just last month. The Epstein Barr and BK virus assays were granted a CE mark and launched in April.
In addition to the Simplexa product line, Focus also markets the HerpeSelect® HSV serology assay, and a line of DxSelect™ IFA and ELISA assays.