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Mobidiag Gets CE Marks for Two Tests

NEW YORK (GenomeWeb) – Mobidiag today said that it has received CE marking for its Amplidiag CarbaR+MCR test and the Novidiag Bacterial GE+ test.

Amplidiag CarbaR+MCR is for detecting the main carbapenemase-producing organisms and colistin resistance markers in one test.

The qualitative multiplex PCR test enables the detection of the KPC, NDM, VIM, IMP, OXA-48, OXA-181, Acinobacter OXA, MCR, and GES genes. According to Mobidiag, the bacteria can cause multiple antibiotics to perform inefficiently, which can result in serious infections. Using stool samples, rectal swabs, or pure culture, the Amplidiag CarbaR+MCR test can provide results in a few hours, rather than days, which is necessary with current culture-based screening methods.

Along with the Amplidiag CarbaR+VRE test, it enables screening for multidrug-resistant organisms, and can prevent their spread in hospital environments, Mobidiag said.

Novidiag Bacterial GE+ is a molecular diagnostic test that concurrently identifies the most common enteric pathogens directly from stool samples. The disposable cartridge allows direct analysis of a patient's sample and produces results in about one hour. It is compatible with the fully automated Novodiag system.