NEW YORK (GenomeWeb News) – Luminex this week said that it xTAG Gastrointestinal Pathogen Panel has been CE Marked. The PCR-based panel simultaneously detects and identifies 15 parasitic, bacterial, and viral pathogens, accounting for 95 percent of all gastrointestinal infections. The test can run on the firm's Magpix and Luminex 100/200 systems.
Luminex said that it intends to file for regulatory approval of the panel in the US and Canada, but did not provide a timeline for such filings.
Quest Diagnostics said that its Simplexa C. difficile Universal Direct test has been CE Marked. The test runs on the 3M Integrated Cycler and can process up to 94 patient specimens in an hour. The test was developed by Quest's Focus Diagnostics business. Quest said that it will unveil the C. difficile test along with the Simplexa Epstein Barr Virus and BK Virus tests at the European Congress of Clinical Microbiology and Infectious Disease Tradeshow, which begins in Milan, Italy tomorrow.
Rosetta Genomics this week said that it has launched its US oncology sales team to commercialize its microRNA-based diagnostic tests. The initial team has four oncology sales specialists, each of whom has a minimum of nearly 20 years of relevant sales experience, said Rosetta. The firm also said that it expects to expand the sales team over the coming quarters.
Med BioGene this week said that its full-year 2010 net loss was C$2.9 million (US$3 million), or C$.04 per share, compared to a 2009 net loss of C$2.1 million, or C$.04 per share. The Vancouver, British Columbia-based molecular diagnostics firm reported no revenues for either year. Its commercialization partner, Precision Therapeutics, is preparing to launch Med BioGene's first product, the LungExpress Dx, a multi-gene prognostic test for non-small-cell lung cancer.