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Ep139: Kevin Conroy on Early Detection of Cancer

The Long Run with Luke Timmerman

CHAPTER

The Importance of a Parallel Review With CMS

The next big move that you made was the FDA CMS parallel review. Can you describe for people what that was and why that was important? Yes, so in our very first meeting with CMS, they said, look, you need a national coverage decision because it's a cancer screening test. And I thought to myself, well, we can barely afford an FDA clinical study. How in the world are we going to then run a second one after that?

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