FEND-TB

About This Grant

Among the estimated 10 million people with tuberculosis (TB) in 2022, over 3 million were not diagnosed, underscoring the need for new tools and diagnostic strategies to improve TB case detection, including in difficult to-diagnose populations such as children and people with extrapulmonary or early/subclinical TB. An equally urgent need is for drug susceptibility tests (DST) that can rapidly identify TB drug resistance/susceptibility, including to new drugs, to cure each person with TB and to protect the efficacy of newer drugs for those who may benefit from them in the future. Partially fueled by innovative platforms developed to address the COVID-19 epidemic, the last decade has seen a surge of new TB diagnostic platforms and assays. These new tests, sometimes developed by small companies with limited resources and little or no experience working with Mycobacterium tuberculosis (MTB) and clinical TB, require rigorous and unbiased evaluations. Furthermore, many diagnostic developers do not sufficiently appreciate the challenges presented by sample processing, the (often) need for high test sensitivity, or the acceptable tradeoffs between sensitivity/specific versus assay costs, ease of use and relevant target populations or TB disease states. Thus, the unmet needs of TB diagnostic developers are specific to the type of manufacturer, diagnostic technology, assay format, and intended use. Our proposal brings together a consortium of experienced investigators and a global network of clinical research sites to support TB diagnostic evaluations through a fast-paced and flexible pipeline that includes tech scouting, development mentoring, and clinical testing of early-stage TB diagnostics. With the inclusion of an Analytic Laboratory Core that can assess and help optimize new technologies prior to and after clinical studies our program offers a unique opportunity to accelerate promising TB diagnostics through their optimal development pipeline. Consortium members have almost three decades of leadership experience in diagnostic tech scouting, research, development, clinical trialing, and implementation activities. Fielding a balance of established platforms, fast followers, and cutting- edge technologies, we will perform the following specific aims: 1) identify promising early-stage diagnostics for evaluation and develop for each a stepwise evaluation plan; 2) evaluate the diagnostic accuracy of novel rapid point of care/near care TB diagnostics and determine the impact of relevant patient characteristics on test accuracy; and 3) provide feedback to diagnostic developers, policymakers, and other stakeholders on performance and usability of novel diagnostic tests and potential strategies for use in TB endemic settings.