TB Diagnostics: Top 10 FAQs By Test Developers

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Useful resources for each question are now available on our website.
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Based on input from 25+ companies and test developers, these are the most critical questions of relevance to test developers and companies wanting to develop TB diagnostic technologies. Useful resources for each question have been posted.
1
TB BURDEN AND TREATMENT LANDSCAPE

What is the global burden of TB (including latent TB, TB/HIV and MDR/XDR-TB) and what is the current and future TB treatment landscape? (Read more)

2
CURRENT DIAGNOSTICS LANDSCAPE AND PIPELINE

What is the current testing landscape for TB (including latent TB and DST), and what diagnostics are in the pipeline? What is the level of access to current TB diagnostics? (Read more)

3
MARKET SIZE, POTENTIAL AND DYNAMICS

What is the market size and potential for new TB diagnostics, and what are the market dynamics around TB diagnostics? (Read more)

4
TARGET PRODUCT PROFILES

What are the unmet diagnostic needs and target product profiles (TPPs) of greatest relevance? (Read more)

5
PRODUCT DEVELOPMENT SUPPORT

Where and how can test developers and companies get funding, technical assistance and secure necessary specimens/strains for test development and quality control? (Read more)

6
PRODUCT VALIDATION SUPPORT

What kind of validation is required for a new TB diagnostic in order to enter the market and where can companies get support for such validation? (Read more)

7
REGULATION

What are the regulatory requirements for TB diagnostics, both in-country and globally? (Read more)

8
POLICY

Are global policy endorsements required? If so, what kind of evidence is necessary for global policy endorsements and scale-up? (Read more)

9
PROCUREMENT AND MARKET ACCESS

How do countries procure TB diagnostics? How autonomous is their decision making? How much is it influenced/guided by WHO and/or donors? (Read more)

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