Roche announced that the cobas MTB and cobas MTB-RIF/INH tests for use on the cobas 6800/8800 Systems are included as part of the updated World Health Organization (WHO) policy guidelines on nucleic acid amplification tests (NAATs) to detect tuberculosis (TB) and drug-resistant TB. The new guidance expands the number of rapid molecular tests available to national TB programmes in high-burden countries, enabling multi-partner diagnostic approaches that can benefit patients and communities.

The WHO estimates that about 1.7 billion people are living with tuberculosis globally, with an estimated 10 million new active tuberculosis cases and 1.4 million deaths annually. Approximately 29% of new infections were undiagnosed and untreated, potentially contributing to further transmission. When drug-resistant TB (RR/MDR-TB) is present, the challenge is greater, with only 44% properly diagnosed. Although TB can be cured once it is diagnosed, people affected are often faced by vulnerability, marginalization, stigma and discrimination.

To increase early detection, diagnosis, and treatment of TB among vulnerable populations, the updated WHO guidelines aim to help countries identify populations at highest risk of infection and the locations most affected. This includes 30 low- and middle-income countries (LMICs), which bear the majority of the TB burden. These countries rely on the WHO to evaluate test performance and provide centralised testing guidance and diagnostic guidelines prior to the use of any TB test. The new policy guidance enables LMICs to use donor funds for implementation and purchase of TB tests, increasing diagnostic options for people living with TB and drug-resistant TB.

“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,” said Thomas Schinecker, CEO Roche Diagnostics. “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 an important step toward ending the global TB epidemic by increasing patient access to high-quality diagnostics. The organisation’s multi-faceted End TB Strategy aims in part for a 90 percent overall reduction in TB incidence and a 95 percent reduction in TB deaths by 2035. High-volume, multi-disease testing systems and innovative diagnostic tests can accelerate eradication efforts and further improve health outcomes for people living with TB.