Tuberculosis

Tuberculosis (TB) remains a leading cause of global mortality, with an estimated 10.6 million new TB cases and 1.6 million TB-related deaths annually.  Tuberculosis is a serious illness caused by a bacterial infection that mainly affects the lungs, although the infection can reside in other parts of the body. Tuberculosis can spread when a person with the illness coughs, sneezes or otherwise disperses tiny droplets containing the bacteria into the air, which another person can then inhale. 

According to the 2023 Global Tuberculosis Report by the World Health Organization (WHO), there are approximately 10.6 million new TB cases recorded annually, accompanied by 1.6 million TB-related fatalities.  3.1 million (41.3%) of active TB cases around the world were missed in 2022 and only 57% of diagnosed cases are confirmed by gold-standard TB tests.TB diagnosis challenges can be magnified in children and in individuals living with HIV, who respectively account for 12% and 8.2% of existing TB cases , due in part to the difficulty of obtaining useful sputum samples from these individuals and the potential paucibacillary nature of these samples.

TB diagnosis remains challenging, however, and is still widely dependent on smear microscopy, which has moderate sensitivity and specificity, and culture, which has a long sample-to-answer time. Newer methods, including Elispot and Elisa Blood assay tests and other PCR assays, have not had the hoped-for impact on global TB due to their limitations. Blood-based immunology tests cannot distinguish active TB from latent TB infection, and perform poorly in pediatric groups and HIV infected patients. PCR-based sputum assays employ nucleic acid amplification to detect TB DNA and permit rapid diagnosis of TB when analyzing sputum samples, but require special instrumentation not broadly available in resource-limited settings and also detect both live and dead bacteria; further, certain climates and conditions have caused difficulty in automation implementation due to a low temperature ceiling. Finally, none of these diagnostic methods provide quantitative results that can be employed to rapidly monitor treatment response. 

The IntelliGenome team has developed a CRISPR-TB Blood Test*, a novel diagnostic approach that is rapid, serum/plasma-based, suitable for all patient cohorts, and cost-effective in delivering clear and actionable insights into active TB cases – regardless of whether they are pulmonary or extrapulmonary in nature. Furthermore, the impact extends to underserved patient groups, encompassing young children, infants, individuals co-infected with HIV, and patients afflicted with paucibacillary TB. We are confident that the clinical translation of this technology holds the potential to empower healthcare providers worldwide in the comprehensive fight against diverse forms of TB across all patient cohorts.

*The CRISPR-TB Benchtop Assay is for research use only, while the POC and LIT versions are in development and not yet approved for clinical or diagnostic use.