The Roadmap to new TB diagnostics

The overall vision of the New Diagnostics Working Group’s Strategic Framework 2016-2020 is to achieve early and universal diagnosis of all patients with all forms of TB to foster progress towards TB elimination, by making appropriate and affordable diagnostic solutions available at the right setting and ensuring that diagnostic results are linked to treatment.

The Framework sets the following goals and corresponding diagnostics that will be required to reach the goal of ending TB by 2035:

  1. Reduce the current gap of 3 million cases missed each year and improve TB case detection. This will require a range of tests that can be used in a patient-centered fashion and deployed at all levels of the healthcare system, including at the point of care, for all populations, including children and those living with HIV, as well as innovative diagnostic strategies that will ensure better outreach to patients.
  2. Enable timely and effective treatment to reduce mortality and ongoing transmission, and prevent antimicrobial resistance by ensuring universal access to DST. This will require rapid and simple tests for detection of drug resistance in decentralized settings for existing and future drugs, as well as tests to assess response to therapy and cure.
  3. Support the goal of disease elimination by addressing the reservoir of TB infection and efficiently introduce targeted preventive therapy. This will require tests for predicting the risk of progression from latent infection to active TB disease.

The following objectives are designed to guide progress toward the overall goals for the 2016-2020 period:

Objective 1: Ensure that the critical knowledge enabling the development of new diagnostic tools and solutions, including alternative approaches for case finding, is available.

Objective 2: Develop a portfolio of new diagnostic tools coupled with a package of accompanying solutions to ensure that results translate into patient treatment.

Objective 3: Evaluate the portfolio of new diagnostic tools and solutions, including new detection strategies, approaches for optimized use, and innovative delivery mechanisms, demonstrate patient benefit and predict likely impact for entire health systems and populations.

Objective 4: Ensure that fully validated new diagnostic tools and solutions are widely available and appropriately used in endemic countries.

The Strategic Framework 2016-2020 identifies milestones and activities to support these objectives, as well as the required funding for each milestone for the five-year period.

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