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July 12, 2021updated 02 Nov 2021 6:39am

WHO guidelines include Roche’s tuberculosis diagnostic tests

The company’s mycobacteria tests can detect a combination of TB and drug-resistant TB infections from one patient sample.

Roche has reported that its cobas MTB and cobas MTB-RIF/INH tests are included in the latest World Health Organisation (WHO) policy guidelines on nucleic acid amplification tests (NAATs) for tuberculosis (TB) and drug-resistant TB detection.

The latest guidance increases the number of rapid molecular tests for national TB programmes in high-burden countries, providing multi-faceted diagnostic methods that can aid patients and communities.

The two Roche mycobacteria tests are indicated for use on the cobas 6800/8800 Systems to identify a combination of TB and drug-resistant TB infections using a single specimen obtained from the patient.

When an individual shows TB symptoms, the high-sensitive cobas MTB test is conducted. On obtaining a positive result, drug resistance is assessed with the cobas MTB-RIF/INH test.

Compared to other automated molecular platforms, the cobas 6800/8800 Systems can deliver results in less time at increased throughput and with the longest walk-away time available.

Furthermore, these systems are part of the Molecular Work Area, a completely integrated lab workflow approach that allows labs to enhance their efficacy, flexibility and scalability levels.

Roche Diagnostics CEO Thomas Schinecker said: “Roche’s diagnostic solutions detect both TB and drug-resistant TB, enabling patients to be diagnosed earlier and treated with the appropriate regimen to stop the spread of the disease.

“Roche plays a significant role in the fight against TB through our Global Access Program, which focuses on sustainable solutions that can help diagnose infections and save lives.”

WHO guidelines are a vital step to end the TB epidemic globally by boosting patient access to high-quality tests, Roche noted.

Through its phased End TB Strategy, WHO intends to lower overall TB incidence by 90% and anticipates a 95% decline in TB deaths by 2035.

Last month, Roche received Emergency Use Authorisation from the US Food and Drug Administration for the use of its cobas SARS-CoV-2 Nucleic acid test in point of care settings.

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