The reality continues that the FDA cannot keep a domestic company from selling its products overseas when they are approved there. Another example is tiny Guided Therapuetics out of Atlanta. The FDA has turned it down three times, but the company is doing business in several countries around the globe and is working on many more. It's a device as well. LuViva is a light activated system that can give immediate readings on cervical cancer without pap smears and other lab work. The developing world is starting to pick up on it. I don't imagine domestic laboratories are too keen about it being introduced here at some point.
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