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?


  1. 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?
  2. 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?
  3. Who can provide clinical trials and validation support to companies?
  4. What will it cost to conduct clinical validation studies? Will donors and funding agencies pay for product validation?
  5. Which academic institutions and laboratories are capable of TB test validation and field trials?
  6. 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?


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