What are the unmet diagnostic needs and target product profiles (TPPs) of greatest relevance?
- Which attributes* within the TPP are the most important to focus on? What are the top 4-5 features that are needed in a TB diagnostic test for developing countries?
- At what price/cost can a new TB diagnostics be sold (depending on volume)? What is the current and projected pricing environment over the next 5-10 years?
- What are the differences in the market opportunities for a screening test and separately for a drug susceptibility test (DST)? How is the price/cost affected if the new test is a screening (broadly used) test versus an “add-on” or reflex test?
- How critical is it to include DST in the test? Which drugs are critical for DST now, and in the future? Is it advantageous to have a platform that can detect a large number of mutations? What is the cost-benefit ratio of having these additional elements in the test?
*Attributes include target cost, sensitivity/specificity (which is more important and what is the minimum acceptable level?), infrastructure requirements (e.g. power, temperature control), time to result, throughput, sputum versus other samples, manual versus automated, requirements for reporting of test results, point-of-care versus centralized lab testing, integrated or reflex drug resistance test, which drugs to include in DST, TB only test versus multiplexed platform, other key assays (i.e HIV, CT/NG) that need to be available on the same platform, shelf-life requirements, instrument/test connectivity requirements, importance of subgroups such as HIV-infected and children, etc.