FDA authorization has nothing to do with insurance coverage. I know of a small manufacturer that's had an authorized product on the market for over 3 years, not a single insurance company will cover it.
Insurance coverage is basically a waiting game between manufacturers and insurance companies. If you have enough capital to wait it out and schmooze executives, then you can get coverage. If not, good luck to you.
FDA approval makes it considerably easier, and in many cases possible at all, to get reimbursement for these tests. I work in the field and this is a constant hurdle to overcome.
In many cases medical insurers outsource decisions on what tests to cover to care guideline vendors such as MCG and Change Healthcare (Optum). Those vendors periodically update their guidelines based on medical research and evidence-based medicine protocols. For a new test to be covered it generally has to demonstrate some clear benefit in terms of improved patient outcomes.
Insurance coverage is basically a waiting game between manufacturers and insurance companies. If you have enough capital to wait it out and schmooze executives, then you can get coverage. If not, good luck to you.