Tuberculosis (TB) is a curable and preventable disease, however, it is one of the most significant infectious causes of mortality and morbidity worldwide and is the number one cause of death among those infected with HIV. TB occurs across the world. In 2019, the largest number of new TB cases occurred in the WHO South-East Asian region, with 44% of new cases, followed by the WHO African region, with 25% of new cases and the WHO Western Pacific with 18%. The primary purpose of the FEND for TB Consortium is to evaluate early stage diagnostics and novel diagnostic strategies for tuberculosis in the context of existing clinical algorithms in TB endemic countries.

Lack of diagnosis and delayed diagnosis remain critical obstacles to controlling tuberculosis and improving individual and public health. An estimated one-third of all tuberculosis cases are missed.. Undetected TB and late detection of TB increases the risk of transmitting the disease to others, poor health outcomes, and distress/economic hardship due to illness. While there have been important advances in tuberculosis diagnostics over the last decade, specifically in sputum, there are significant limitations. These include poor feasibility in people who cannot expectorate, irrelevance in those who only have extra-pulmonary tuberculosis (TB in sites other than the lungs), irrelevance in those who have latent infection, and biohazards associated with specimen collection. Much work remains to develop the diagnostics needed for early detection of exposure and drug resistance.

Our Mission

To support the evaluation of early-stage TB diagnostics & novel diagnostic strategies in the context of existing clinical algorithms in TB endemic countries.

FEND for TB will perform proof-of-principle studies of novel diagnostics & strategies and provide feedback to diagnostic developers on the performance of the technologies and their most effective use in endemic settings.

Operations

Rutgers University, Center for Emerging Pathogens hosts the Data and Operations Management Center (DOMC), dedicated to the operations and conduct of sponsored clinical studies. The DOMC currently coordinates and manages 12 NIH-sponsored UO1 and RO1 projects, involving human prospective clinical studies in eleven (11) TB-endemic countries, involving adult, pediatric, MDR-TB in biomarker discovery, diagnostic testing evaluation and epidemiology/genomics.

The DOMC has extensive experience as the Data, Administrative, Operations Management Center for TB CDRC (2009-2016), TB Research Unit (2014-2021), FEND-TB (2020-2025), TB-RePORT International Coordinating Center (2021-2028) and ICIDR programs in activities of biomarker discovery, POC TB diagnostics evaluation, including: design/development of case report forms, data entry/management; operational implementation; quality assurance; statistical analysis; maintenance of study data, documentation and regulatory compliance. Staff at the DOMC have expertise in key areas of data management including clinical coordination, biostatistical analysis, laboratory QA/QC coordination, data capture/data management, regulatory coordination and biorepository management.