The R2D2 TB Network offers access to the following at no cost to product developers:

  • Leading international experts in TB diagnostics research, registration pathways and policy development

  • Key markets and in-country stakeholders for scale-up of novel TB diagnostics

  • A state-of-the-art clinical trial network

  • Experienced clinical trial sites in Asia (India, Vietnam, the Philippines), Africa (Uganda, South Africa, the Gambia, Zambia), Eastern Europe (Georgia) and South America (Brazil and Peru) with extensive TB and respiratory disease expertise

  • Research staff with expertise in the collection of registration quality data

  • Adaptive, master protocols to enable rapid and iterative inclusion and evaluation of early/late prototypes and large-scale validation studies

  • Access to diverse populations of adults, children and high-risk groups (including people living with HIV, diabetes mellitus, others)

  • Rigorous reference standards for accurate classification of TB status, including resolution of false positives through additional testing and patient follow-up

  • Banked samples for pre-clinical studies and assay optimization

  • Standardized feedback on usability and acceptability of novel TB diagnostics from end-users

  • State-of-the-art economic analysis and transmission modeling to support the use-case for diagnostics

Partner with Diagnostic Developers

We seek to partner with innovators who are developing innovative solutions for TB diagnosis. Innovators in industry, academia or philanthropically-directed programs with technologies at any stage of development can take advantage of the R2D2 TB Network and associated resources at no cost. The R2D2 TB Network is also able to support evaluation of multi-pathogen assays that include diagnosis/triage capabilities for TB. We leverage our technical expertise within and outside of the TB field to help diagnostic developers identify the optimal use-case for their products, obtain key stakeholder input and advance products along the development pipeline.

We focus on products that meet any of the following high priority target product profiles for TB diagnostics:

  • TB triage test to rule out disease and for systematic screening of high-risk populations
    • Rapid, low-cost tests that can filter out patients with TB symptoms (triage) or risk factors (screening) that do not require more expensive TB diagnostic testing, reducing costs for TB programs
  • TB diagnostic test to confirm disease
    • Rapid, cartridge-based molecular test to replace sputum smear microscopy
    • Rapid, biomarker-based test that can be performed on simple-to-collect samples (blood, urine, breath, saliva) at the lowest levels of the health system
  • Next-generation drug susceptibility test
    • Rapid drug-susceptibility test that can be used at lower levels of the health system to identify resistance to isoniazid, rifampin, fluoroquinolones and second-line injectables
    • Centralized, high-throughput drug-susceptibility test incorporating testing for new anti-TB agents to support the roll-out of new TB treatment regimens

Provide access to an international network of TB diagnostics trial sites

Our clinical study sites are unique, robust, and relevant in the following ways:

  • Geographic diversity:We are connected to sites in South Asia, Southeast Asia, Eastern Europe, Southern Africa, Eastern Africa, Western Africa and South America.
  • Representation across different TB epidemics: We work in countries with high TB burden, high HIV/TB burden, high MDR TB burden, and/or high (>5%) diabetes prevalence. Our network facilitates evaluation of novel TB diagnostics in the specific target population(s) needed for further development of a particular test: adults and children with TB symptoms, high-risk groups for whom systematic TB screening is recommended (PLHIV, people living with diabetes, prisoners), and patients with advanced drug resistance phenotypes.
  • Access to key markets for scale-up of novel TB diagnostics: We work in three BRICS countries and two additional countries that are ranked among the top 20 in the world based on population and the absolute number of TB cases.
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Facilitate collection of high quality data on performance of TB diagnostics

Conducting field evaluations and obtaining end-user feedback pose a significant hurdle to developers on the value chain from early prototype to market entry, resulting in significant delays and costs that hinder investment in TB diagnostics development. Our deep expertise in TB diagnostic evaluations and network of high-quality clinical study sites in high burden countries make us well-positioned to overcome this hurdle and encourage product developers to enter and advance in this field.

Our field evaluations follow recommended guidelines for evaluating novel screening/triage, diagnostic and drug resistance tests. For screening/triage and diagnostic tests, we include a comprehensive reference standard for pulmonary TB, additional testing to assess for extra-pulmonary TB and clinical follow-up for up to 6 months to help clarify potential false-positive results from novel tests. For drug resistance tests, we include comprehensive phenotypic drug susceptible testing at reference laboratories and whole genome sequencing.

For all novel tests, we design studies to reflect their stage of development. We nest smaller feasibility studies of earlier prototypes within large, multi-center evaluations of design-locked products to provide timely feedback to product developers. We also perform standardized ease-of-use assessments and interviews with end-users to anticipate potential barriers and advantages of implementation.

Perform economic and impact modeling to help advance TB diagnostics

The costs, cost-effectiveness, and affordability of implementing novel diagnostics are a key consideration at early and late stages of development. Our internationally-recognized modeling team assesses the incremental value – in terms of potential costs and epidemiological impact – of novel TB diagnostics alone and in combination with other tests.