In 2021, an estimated 10.6 million people developed active TB, resulting in 1.6 million deaths*. There are currently limited options for monitoring the disease, but for the last five years, LifeArc has been working with collaborators from the University of St Andrews on developing the TB-MBLA – a test that could be used for both diagnosis and monitoring of TB over time.
The assay targets 16S rRNA from actively growing TB cells, which has been shown to be a more reliable indicator of active infection than DNA targets. In addition, with results available in a few hours, TB-MBLA has significantly shorter time to result compared with methods such as TB culture.
How is the TB-MBLA test being used?
LifeArc has now configured the assay as an RT-qPCR kit suitable for research use only.
The kit is currently being assessed in the TIME study (TB DIagnosis and Monitoring Evaluation) which is running in four clinical sites across Tanzania and Uganda until the end of 2024. The aim of the study is to evaluate how accurate the assay is at detecting TB in sputum samples from participants with pulmonary TB, compared with a number of other established diagnostic methods currently used in TB clinical care around the world.
*WHO Global Tuberculosis Report 2022