NOT EVEN CLOSE TO TRUE.......
ARYC/ADVX haven't done any qualified and required testing to even see if OvaDx even works enough to approach the FDA with a PRE-IDE filing seeking approval to perform a strictly controlled and taxing trial under protocols set by the FDA to see if that meets required efficacy to support even a limit commercial use of OvaDx.
The just finally announced they have authorized DOCRO to hire a FDA approved clinical investigator to oversee this initial testing and they are apparently looking for a lab to do the testing.
Testing was suppose to happen in a ARYC lab but there isn't one and ARYC doesn't even have the equipment to do the testing to FDA standards.
Now if they use an outside lab for this 1st piece, it in itself becomes a problem for later trials because the ultimate data has to be on all components of the "test" that one seeks to use commercially. That's the biomarkers, the microarrays, the algorithms, the equipment, the process, etc....
They are far away from knowing if it even works and way, farther away from even the 1st process with the FDA and way, way far away from any possible FDA approval (if at all).
And the steps down the road will costs several million dollars that nobody has....
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