Laboratory Diagnostic Tests | Assessment
When developing a laboratory diagnostic test, the regulatory and commercialization pathway depends heavily on how the test will be used, where it will be performed, and the level of risk associated with its results. The following assessment will help you clarify your test type and potential pathway.
Time limit: 0
Quiz Summary
0 of 8 Questions completed
Questions:
Information
You have already completed the quiz before. Hence you can not start it again.
Quiz is loading…
You must sign in or sign up to start the quiz.
You must first complete the following:
Results
Quiz complete. Results are being recorded.
Results
Time has elapsed
Categories
- Not categorized 0%
-
A copy of your answers has been sent to your email for your records
Checklist for Founders
- Is my lab CLIA-certified and capable of maintaining CLIA compliance?
- Does my test need FDA clearance or approval for nationwide adoption?
- Is my test tied to a therapeutic product, requiring drug-diagnostic co-development?
- Have I evaluated the timeline and costs of each pathway?
- Do I understand the reimbursement environment for my diagnostic?
- Have I identified potential partners (labs, pharma, device manufacturers) for scale up?
- Review
- Answered
- Correct
- Incorrect
-
Question 1 of 8
1. Question
CorrectIncorrect -
Question 2 of 8
2. Question
CorrectIncorrect -
Question 3 of 8
3. Question
CorrectIncorrect -
Question 4 of 8
4. Question
CorrectIncorrect -
Question 5 of 8
5. Question
CorrectIncorrect -
Question 6 of 8
6. Question
CorrectIncorrect -
Question 7 of 8
7. Question
CorrectIncorrect -
Question 8 of 8
8. Question
CorrectIncorrect