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?
- How many validation studies will be required to introduce a new TB diagnostic? Are test accuracy studies adequate, or clinical impact studies required? How much geographical diversity is needed for the clinical trials and validation?
- What validation studies were required for, and conducted by Cepheid to bring their TB test to market? How much did it cost and who paid for it?
- Who can provide clinical trials and validation support to companies?
- What will it cost to conduct clinical validation studies? Will donors and funding agencies pay for product validation?
- Which academic institutions and laboratories are capable of TB test validation and field trials?
- Which are the product development partnerships (e.g. FIND, PATH, CHAI, IDRI) or agencies (e.g. CDRC) that can provide support with validation and what are their criteria/conditions for providing support?