2022 World TB Day

Worldwide, 1.7 billion people representing ~23% of the global population, were infected with the Mycobacterium tuberculosis (TB) bacterium in 2018. As the leading cause of mortality among infectious diseases, TB accounted for 1.5 million deaths in 2020, with 230,000 of these deaths occurring in children. The same year, 10 million people became ill with the disease worldwide, including 1.1 million children, yet 30% of all these affected people did not receive the necessary healthcare to effectively treat their conditions, allowing further transmission of TB in the population. The World Health Organization (WHO) “End TB Strategy” is aimed at ending the global TB epidemic by 2030, with the goal to reduce deaths by 95% and new cases by 90% between 2015 and 2035.

Childhood TB disease is rarely detected or treated: The mortality rate of TB disease in children is significantly higher (23% in 2018) than in adults (14% in 2018) due to a TB diagnosis-treatment gap. Current TB tests require sputum, which is difficult to obtain from productive coughs in infants and young children. Furthermore, the relatively small number of bacteria (paucibacillary disease) typically found in infected children is below the detection limit of existing TB testing technologies. Therefore, current TB tests are unlikely to show a positive result in children. Studies based on modeling pediatric TB cases worldwide indicate that over 90% of children with TB disease never receive treatment and up to 95% of childhood TB deaths are not diagnosed or treated before the child dies. Greater than 95% of TB deaths occur in low- and middle-income regions, making rapid and cost-effective point-of-care TB testing a critical need for effectively preventing and treating TB disease in children. Early detection and diagnosis of TB in children combined with early therapeutic interventions could cure the vast majority of affected children.

Unmet Need: Currently, a rapid, sensitive, and cost-effective point-of-care screening test for TB in children does not exist. The WHO End TB Strategy is to treat at least 70 million people with latent TB and TB disease over a 5-year period by 2022, which would likely reach over 10 million children. To do this requires rapid point-of-care diagnostics that are more sensitive and accurate than existing tests, and that can be performed in non-sputum samples such as saliva and urine in minutes at a low cost. To address this critical and unmet global health need, GenEndeavor is working on new molecular technologies to develop a rapid low-cost sensitive community-based point-of-care TB test that can identify Mycobacterium tuberculosis in children directly from unprocessed saliva and urine in under 10 minutes without any lab equipment, enzymes, or electricity to enable early TB testing and diagnosis in children globally in decentralized settings.