Good point JD. Without a predicated device, effectively there was no way to conduct a valid comparison of data since there was no control and at the end of the day, this was a massive stumbling block for the FDA (510)k passage of Oraline. You can not help but think that others that claim they are close to FDA creditation perhaps may be awaiting the same fate as Oraline. There are also political forces at play here. Large companies are risk averse and therefore they very much fall in line with policies and regulations that are determined by Govt. In this case, FDA clearance has been issued to some urine based products on the market today and a substantial spend has been made in infrastructure type processes such as laboratory testing networks. A shift to saliva testing at the larger end of the corporate spectrum will I suspect be a function of both cost, production downtime and privacy issues. It is changing but once the FDA(510)k hurdle is cleared, it may just be that it becomes significantly easier as you suggest, for others to gain such a creditation in a much shorter time span and I guess that at this point, a new testing regime would have been herald in to the market place.
ciao
SBN Price at posting:
0.0¢ Sentiment: ST Buy Disclosure: Held
