NEW YORK (GenomeWeb News) – IntelligentMDx today said that it has gained ISO certification from Canadian authorities to develop and manufacture its molecular diagnostic tests at its facilities in Cambridge , Mass., where the firm is based.
IMDx said that it underwent an audit of its quality system to ISO 13485:2003 with the implementation of requirements from the Canadian Medical Devices Regulations. The accreditation was received from the Laboratoire national de métrologie et d'essais and will enable the firm to seek licenses to commercialize its tests in Canada.
IMDx's portfolio includes CE-marked tests for toxigenic Clostridium difficile, vancomycin-resistant enterococci, and Group B streptococcus. It also is developing assays for herpes simplex virus 1 and 2, influenza A/B and respiratory syncytial virus, Epstein-Barr virus, and BK virus.