A blueprint for new TB diagnostics development is available from the Stop TB Partnership’s New Diagnostics
Working Group: http://www.stoptb.org/wg/new_
The following agencies are actively engaged in product development in diagnostics:
1. FIND ( Foundation for Innovative New Diagnostics)
2. PATH (Program for Appropriate Technology in Health)
3. IDRI (Infectious Disease Research Institute)
4. Private equity. WHO and Gate Foundation spearheaded an initiative for manufacturers to finance their own R&D; suggesting a proportion of revenue that should be devoted to R&D. Here is a link to the reports of WHO CEWG on R&D financing http://www.who.int/phi/news/cewg_meetings_2011/en/index.html
5. Global Health Investment Fund
FIND/TDR provides TB specimen which can be acquired through specimen bank: http://www.finddiagnostics.
The required and desired standards of specimen are different in different stages of assay development. This is important for manufacturers and assay developers to validate their assay to international standard. The critical steps along the pathway for assay development when specimen banks might be required are as following:
- Phase I prototype and optimisation studies.
- Phase II demonstration studies.
- Phase III (on design lock down product) validation and verification studies including analytical studies (stability, accuracy of measurement such as repeatability, reproducibility), clinical trials for clinical evidence of safety and performance including clinical sensitivity and specificity.
Additionally it is important to specify the sample size and exact type of specimens that would be required for a clinical trial that meets international standards i.e. in the phase after prototype development for gaining WHO PQ and/or national registration.
(It is important to plan ahead, incorporating product validation and getting contact with regulatory agencies at the inception phase of product development.)