CE-IVD marking of Novodiag® CarbaR+, the 3rd molecular test on the automated system Novodiag®, for detection of the main Carbapenemase-Producing Enterobacteriaceae (CPE) and colistin resistance markers in one single test.
ESPOO, Finland, January 7th, 2019 – Mobidiag Ltd. today announces the CE-IVD marking of Novodiag® CarbaR+. Novodiag® CarbaR+ is a single molecular test allowing fully automated detection of Carbapenemase-Producing Enterobacteriaceae (CPE), and associated resistance markers. 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.
Tuomas Tenkanen, CEO of Mobidiag, said, “Antimicrobial resistance is one of the most significant challenges to global health. Mobidiag is contributing to the fight against “super bacteria” by developing innovative diagnostic tools. Novodiag® CarbaR+ is our third test on the Novodiag® system and strengthens our offering in the fight against antibiotic resistance. Together with our Amplidiag® and Novodiag® tests, we offer comprehensive diagnostic solutions to a wide range of infectious diseases in both centralised and decentralised laboratories regardless of their size and patient volumes”.
The Novodiag® CarbaR+ test is now available directly through Mobidiag and local distributors. For more information, visit our product page.
About Novodiag® CarbaR+ (CE-IVD)
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.
Dorothee Allard, Marketing Communications Manager
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Consilium Strategic Communications
Chris Gardner, Matthew Neal, Chris Welsh
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Andrew Craig, Partner
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