Biological dynamics and lab developed test

Reference no: EM133580110

With respect to Biological Dynamics, lab developed test (LDT), ExoVita^TM Pancreas in the company's. Kindly answer the following

1. What was their regulatory, guideline and reimbursement approval / inclusion roadmap? What types of studies (as in what were they trying to prove)? In what sequence? With what design in each case?

2. Are they following the EDRN steps for validating a new surveillance dx? Or some other? Can we generalize about what roadmaps the different comparable seem to be following

3. Were each of the studies well designed to achieve their stated goal? Were each of the studies successful? If not, in what way did they fail?

4. Was the test successful in its entry into the market? If so, describe in quantitative terms. If not, why not? Was failure in the market related to failure in the execution / outcome of the studies from the roadmap?

5. What is the data they put in order for regulatory approval?

6. What was the national and local coverage determination for Medicare they took

7. Is there anything that they could have done differently in reg, guidelines, reimbursement approvals / inclusion areas that would have made a difference, or enough of a difference to overcome failure in the studies from the roadmap?

8. What the details and timelines of their process, and are they a good template for ExoVita to follow?

Reference no: EM133580110

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