Mobidiag's Novodiag CarbaR+ test to detect resistant bacteria receives CE-IVD mark

Mobidiag announced Monday that its single molecular test, called Novodiag CarbaR+, gained the CE-IVD marking to detect carbapenemase-producing Enterobacteriaceae (CPE) and associated resistance markers. The company noted that the fully automated test is also able to identify a plasmid-mediated resistance to colistin.

CEO Tuomas Tenkanen remarked that "Novodiag CarbaR+ is our third test on the Novodiag system and strengthens our offering in the fight against antibiotic resistance." Mobidiag also offers Amplidiag CarbaR+VRE and Amplidiag CarbaR+MCR, which detects the main carbapenemase-producing organisms and colistin resistance markers in one single test, with the latter product launched last April.

According to Mobidiag, Novodiag CarbaR+ combines multiplex qPCR and microarray testing in a single product, "allowing cost-effective and fast analysis of the most common CPE and colistin resistance markers," including the following genes: KPC, NDM, VIM, IMP, OXA-23, OXA-24, OXA-48/181, OXA-51, OXA-58 and MCR-1. The test runs on the automated Novodiag system, "producing results in 80 minutes with less than five minutes hands-on time directly from pure culture and rectal swabs," the company added.

In December, Mobidiag entered into a partnership with Autobio Diagnostics to set up a joint venture to commercialise the Novodiag platform in China. For related analysis, see The Wider View: Mobidiag's cost advantage plays to China's value demands.

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