PEB - Pacific Edge Ltd

**Minerbarejet** · 12-10-2014, 07:47 AM

Mac, empty your PM please,
Miner

**BFG** · 12-10-2014, 10:46 AM

Originally Posted by AndyLP

Man, Exact Sciences over in the US is getting it right with their bio marker test for Colon Cancer - Cologuard. Official FDA approval, and now Medicare coverage for those who meet the criteria shortly after. Big gains in the SP consequently.
Disc, still holding a good chunk.

Thanks for bring this up Andy. Would others like to retort on why this has not been brought up before in regards to PEB comercial challengers, especially since it is a publicly listed company?

https://nz.finance.yahoo.com/q/bc?s=EXAS

**barney** · 12-10-2014, 10:55 AM

Originally Posted by BFG

Thanks for bring this up Andy. Would others like to retort on why this has not been brought up before in regards to PEB comercial challengers, especially since it is a publicly listed company?

https://nz.finance.yahoo.com/q/bc?s=EXAS

The Cologuard test appears to be a diagnostic test to determine if somebody has colon cancer. PEB's colorectal test is a prognostic test to determine the aggressivness of stage two and three of colorectal cancer. Therefore probably not in direct competition.

**MAC** · 12-10-2014, 11:09 AM

Hi BFG, it does pop up on the thread from time to time, Cologuard is a screening test, Cxcolorectal is a late stage prognostic test, so there is no direct competition between those particular two.

http://www.fda.gov/downloads/Advisor.../UCM390227.pdf

Andy’s point I think was more about what can happen when screening tests like Cologuard and Cxbladder do take off.

There does seem to be a range of colorectal prognostic companion diagnostic tests on the market which would compete with Cxcolorectal, that’s not new news and some of those products have been around for a few years now.

Cxbladder has an edge because it is the first to the market with fully RNA based technology and outperforms the existing competition that has also been around for years, this is why all Pacific Edge resources are focused upon it at present rather than colorectal or melanoma cancers.

There does seem to be a place in the market for Cxcolorectal too though particularly if it also performs well.

The likely market is Japan where they now have the patent rights, possibly a partner agreement with a Japanese pharma whom may require a complementary companion diagnostic test.

Some of the US pharma’s have had their own colorectal companion diagnostic tests for some time now, Roche for example, other european pharma's too.

**Dentie** · 12-10-2014, 03:21 PM

Andy may also be making the point that if PEB had gone the extra and got FDA approval for CxBladder - the deal with CMS would already have been well in the bag and the SP way up.

It seems to me the FDA are the big kahuna's that need to be satisfied for anybody trying to break into the medical market in the US. Yes, it is possible to get in without FDA but as we are witnessing...the wait is laborious.

**AndyLP** · 12-10-2014, 08:39 PM

Correct Mac and Dentie, there does seem to be numerous similarities between cxBladder and Cologuard. Which is why I find it confusing that Pacific Edge inform us FDA approval is not necessary, yet Cologuard has it anyway. I thought it might be because Cologuard appears to be marketed very much as an 'at home' test versus cxBladder being aimed at Urologists.

I wonder if it is a matter of simply 'going the extra mile' to get it, and if it would in fact help speed up CMS coverage.

Probably worth hearing if the company's position on FDA approval has changed recently..

**Slam dunk** · 12-10-2014, 09:46 PM

Originally Posted by AndyLP

Correct Mac and Dentie, there does seem to be numerous similarities between cxBladder and Cologuard. Which is why I find it confusing that Pacific Edge inform us FDA approval is not necessary, yet Cologuard has it anyway. I thought it might be because Cologuard appears to be marketed very much as an 'at home' test versus cxBladder being aimed at Urologists.

I wonder if it is a matter of simply 'going the extra mile' to get it, and if it would in fact help speed up CMS coverage.

Probably worth hearing if the company's position on FDA approval has changed recently..

My understanding was that while it's not necessary, they are working towards it. I think I have read that somewhere.

**MAC** · 12-10-2014, 10:06 PM

Originally Posted by Slam dunk

My understanding was that while it's not necessary, they are working towards it. I think I have read that somewhere.

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