Yes, the advice was provided via Edison;
It seems FDA approval is not necessary at present but may be required in several year’s time due to regulatory changes. The Pacific Edge marketing strategy revolves around securing the large HMO’s, that’s where the big US revenues will come from, CLIA certification is understood by them as the necessary approval. The loose change from direct marketing will require FDA approval if or when they pursue it.
“Pacific Edge management is currently exploring the pathway to full FDA approval for the Cxbladder portfolio, which would enable the company to directly market to consumers. At this stage CLIA certification is sufficient for direct selling to physicians given the tests are processed in the company’s own lab”
“Pacific Edge also faces the potential threat of a new regulatory hurdle in the US. On 31 July 2014 the FDA provided notice of its intent to issue draft guidance providing a risk-based framework for new regulatory requirements of LDTs such as Cxbladderdetect. In practice the enactment could take time. According to the framework, the new requirements for LDTs are to be phased in over several years”
“Once reviewed, a product would likely be judged on its safety and would then be required to either follow a formal pre-market approval (PMA) registration process or an optional registration. Given the long notice period, we expect Pacific Edge will have adequate time and resources to prepare for this”
http://www.edisoninvestmentresearch..../pacific-edge1