I'm not so sure that the company lacks experience JJ. They have literally hundreds of products on the market including their microarray kits and the like. Actually, it brings up the question as to whether these devices need FDA approval or whether the company can just go ahead and market them.
In any event the following was taken from one of the many recent pr's. I think they're John Howell's words so they can be taken with a grain of salt I suppose. He talks about filing a "premarket approval application", whatever that means, for OvaDx.
"Arrayit Diagnostics plans to file a premarket approval application for its proprietary Pre-symptomatic Ovarian Cancer Diagnostic Test with the U.S. Food and Drug Administration in the near future. Upon receiving marketing approval, Arrayit Diagnostics will actively market and distribute the test kit worldwide."
That's what we're waiting on at the moment.
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