Molecular Diagnostics: A Rapidly Shifting Commercial and Technology Landscape

By Lucy Sannes, PhD, MBA
 

SURVEY QUESTIONS

Objective: To illuminate trends, current practices, and views about molecular diagnostics technologies and markets

Participation: Individuals in industry and academia who are involved with research, development, or application of molecular diagnostic technologies

1. Please classify your organization.
 
2. Under what functional area do your responsibilities fall?

3. If you are in a research and/or development area, please identify your position. What molecular technologies are you developing, applying, or utilizing?
 
4. What molecular technologies are you developing, applying, or utilizing?
 
5. What are your current major application areas for molecular diagnostic testing?
 
6. While many areas are promising, what do you believe is the most promising major application area for molecular diagnostic testing over the next 2 years?
 
7. What do you believe is the most promising major application area for molecular diagnostic testing over the next 5 years?
 
8. Has your organization in-licensed or acquired (by acquiring another organization) a novel molecular test or technology platform within the past 2 years?
 
9. If your organization is a diagnostic company, how many new molecular tests have you launched as analyte specific reagents (ASRs) in the past 2 years?
 
10. If your organization is a diagnostic company, how many molecular tests have you launched as reagents (not as ASRs or IVD products) in the past 2 years?
 
11. If your organization is a diagnostic company, how many new molecular tests have you launched as FDA cleared or approved products in the past 2 years?
 
12. If your organization is a diagnostic company that is currently marketing and/or developing ASRs, do you plan to eventually seek FDA clearance or approval for these products?
 
13. If your organization is a diagnostic company, please further describe your organization's focus.

14. If your organization is a diagnostic company, by what means is the discovery and development of new molecular tests being done?