NEW YORK (GenomeWeb) — IMDx said today that it has received three additional licenses for sale and distribution of its molecular tests for the Abbott m2000 platform outside the US and EU.
First, the IMDx C. difficile assay for the qualitative detection of toxigenic Clostridium difficile toxin A and B genes, and the Flu A/B and RSV assay for the qualitative detection of influenza A, influenza B, and respiratory syncytial virus have been approved by Health Canada for sale and distribution in Canada.
In addition, the IMDx C. difficile assay has been approved by the Health Sciences Authority for sale and distribution in Singapore, IMDx said.
These tests join the previously licensed IMDx VanR for Abbott m2000 assay in the company's portfolio of tests commercially available in Canada and Singapore.
IMDx, based in Waltham, Mass., has been developing real-time tests for the Abbott m2000 testing system under a multi-year agreement signed between the companies in 2011.
Several such tests have already been CE marked or approved by the US Food and Drug Administration, and IMDx said this week that it has been placing "significant focus" on obtaining international licenses to globally distribute and sell these products.