www.fdanews.com/articles/191310-roche-gets-ce-ivd-mark-for-tuberculosis-antibiotic-resistance-assay
Roche Gets CE-IVD Mark for Tuberculosis Antibiotic Resistance Assay
May 15, 2019
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.