Therapy Areas: Infectious Diseases
Mobidiag Receives CE-IVD Marking for Novodiag CarbaR+ Test, Allowing Rapid Molecular Testing for 'Superbacteria' and Associated Drug Resistance
9 January 2019 - - Finland-based molecular diagnostics company Mobidiag Ltd. has received CE-IVD marking for Novodiag CarbaR+. Novodiag CarbaR+ is a single molecular test allowing fully automated detection of Carbapenemase-Producing Enterobacteriaceae, and associated resistance markers, the company said.

CPE are bacteria that are resistant to carbapenem class of antibiotics. In addition, Novodiag CarbaR+ identifies a plasmid-mediated resistance to colistin. Colistin is considered the drug of last resort for many infections.

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.

These bacteria may cause multiple antibiotics to perform inefficiently, which in turn can lead to serious infections, particularly in healthcare settings.

The test is designed to run on-demand using the automated Novodiag system, producing results in 80 minutes with less than five minutes hands-on time by an operator.

With two multiplex tests already available for screening antibiotic resistance (Amplidiag CarbaR+VRE and Amplidiag CarbaR+MCR), the new on demand Novodiag CarbaR+ test will enable rapid patient screening for multidrug resistant organisms, helping to prevent their spread in a hospital environment, and enabling physicians to guide patient treatment accordingly.

The Novodiag CarbaR+ test is now available directly through Mobidiag and local distributors. For more information, visit our product page.

Novodiag CarbaR+ is combining multiplex qPCR and microarray in one single test allowing cost-effective and fast analysis of the most common carbapenemase-producing enterobacteriaceae and colistin resistance markers.

The complete panel includes the detection of the following genes: KPC, NDM, VIM, IMP, OXA-23, OXA-24, OXA-48/181, OXA-51, OXA-58 and MCR-1.

These may cause multiple antibiotics to perform inefficiently, which in turn can lead to serious infections, particularly in healthcare settings.

This test is run on the on demand automated Novodiag system with results in 80 minutes and less than 5 minutes hands-on time directly from pure culture and rectal swabs.

Mobidiag is a commercial stage molecular diagnostics company addressing the spread of antimicrobial resistance through rapid detection of pathogens and their potential resistance to antibiotics.

Through its Amplidiag and Novodiag solutions, Mobidiag offers a range of molecular diagnostic solutions for the detection of infectious diseases to laboratories of all sizes.

Mobidiag is headquartered in Espoo, Finland, with subsidiaries in France, UK and Sweden.
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