Roche has announced the CE-IVD launch of the cobas® MTB-RIF/INH test to detect resistance to antibiotics within tuberculosis DNA.
This assay is part of the mycobacteria test menu that includes the cobas® MTB and cobas® MAI tests for use on the cobas® 6800/8800 Systems. This continues the expansion of the testing menu on the cobas 6800/8800 Systems, supporting true consolidation and efficient testing.
Tuberculosis is the leading cause of infectious disease deaths worldwide. The rising challenge of drug resistance compounds the tuberculosis global health crisis. The high sensitivity of the cobas MTB test enables increased detection of tuberculosis in challenging smear-negative samples.
A complete mycobacteria test menu provides the flexibility to detect a combination of tuberculosis, drug resistant tuberculosis and nontuberculous mycobacteria infections from a single patient sample. This provides important information for patient care decisions.
The fully automated cobas 6800/8800 Systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms, providing laboratories with improved operating efficiency and the flexibility to adapt to changing testing demands.
The World Health Organization (WHO) estimates that about 1.7 billion people are infected with tuberculosis, with an estimated 10 million new active tuberculosis infections and 1.6 million deaths in 2017. This includes approximately 920,000 tuberculosis infections in people living with HIV/AIDS and 300,000 deaths in this population.
Michael Heuer, CEO Roche Diagnostics, said: “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.
“This menu approach not only aids healthcare providers in addressing the global health challenge that tuberculosis presents, but also provides clinicians with the valuable information they need to properly diagnose these respiratory infections to speed treatment and reduce the spread of infection.”