I was very interested in BDX but decided to wait it out even though their test is superior to anything else on the market.
Two reasons for my hesitation:
1. BDX tests only run on their proprietary machine which costs half a million dollars. How many labs will make that investment?
2. BDX thinks they don't need FDA approval (at least it's not in their project plan) or they can still operate but charge $$$. Apparently, you can still do tests w/o FDA approval but it all looks very confusing. Again, which labs will sign on to a test which is not FDA approved?
These issues may become moot if the initial rollout is so successful that BDX scores some rich partnerships to smooth out the road ahead.
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