Incorporating basic information on disease incidence and prevalence, unmet medical need and present diagnostic capabilities (highlighting regional variations where appropriate).
Overview of the market:
What are the unmet needs of currently available diagnostics?
Specific populations the diagnostic may be used for (e.g. elderly, pediatric populations etc.)
Introduction to the device:
How the diagnostic works
Cost-effectiveness (training, waste disposal, equipment required…)
Validity and reliability data
Clinical profile and post-marketing findings:
Data from pre-FDA approval studies
Data from post-FDA approval studies (if approved)
Include a table summarizing ongoing and completed clinical trials of the diagnostic
A standalone section, summarizing competing technologies in the field
Include information on the status of the diagnostic, i.e., where it is currently approved, in which countries it is approved and for what indications. Should cover EU, US and rest of the world where appropriate.
A short summary of the data presented in the review.