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Roche Gets CE-IVD Mark for Test That Detects Antibiotic Resistance in TB DNA

NEW YORK (GenomeWeb) – Roche today announced the CE-IVD marking of its Cobas MTB-RIF/INH test that detects mutations associated with resistance to the antibiotics rifampicin and isoniazid within tuberculosis DNA.

The assay is part of Roche's mycobacteria test menu that runs on its Cobas 6800/8800 automated molecular platforms and also includes the Cobas MTB and Cobas MAI tests.

"With the addition of Cobas MTB-RIF/INH to the mycobacteria test menu, we are able to equip laboratories with flexible, sensitive solutions to best help them diagnose tuberculosis, which is difficult to detect," Michael Heuer, CEO of Roche Diagnostics, said in a statement.

Heuer said that the firm's menu provides clinicians the valuable information they need to properly diagnose respiratory infections to speed treatment and reduce the spread of infection.

The Cobas MTB test enables the detection of Mycobacterium tuberculosis complex (MTBC) DNA, while the Cobas MAI test enables the direct detection and differentiation of Mycobacterium avium and Mycobacterium intracellulare DNA in symptomatic patients.

All mycobacteria tests have been validated for use with raw sputum, sputum sediment, and bronchoalveolar lavage sediment samples, Roche said.

The high sensitivity of the Cobas MTB test enables increased detection of tuberculosis in challenging smear-negative samples, the firm said.