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Medical Devices / Submissions and Approvals

Roche Gets CE-IVD Mark for Tuberculosis Antibiotic Resistance Assay

May 16, 2019
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Roche earned the CE-IVD mark for its Cobas MTB-RIF/INH test, an assay used to detect antibiotic resistance mutations in the Mycobacterium tuberculosis DNA.

The assay runs on the company’s Cobas 6800/8800 automated molecular platforms and is part of its mycobacteria test menu.

The highly-sensitive test helps clinicians in speeding up the diagnosis and treatment of TB by detecting antimicrobial resistance.

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