Best I can come up with is that the second to last microhematuria in your quote P15 paragraph 4 should read macrohematuria. It would appear to make sense to me if that is done.
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In 2011 CMS reduced its reimbursement for Urovysion(at the time the only FDA cleared test for bladder cancer) by 50%,out of the blue.(under a new pricing code)
They apparently believed Abbott was taking advantage with their pricing.
Im still trying to figure out what if any ramifications this poses for PEB.
The article says it brings into the discussion molecular tests and the prices charged for them.
It also says this could open the market for other competitors,which seems like it could be a good thing for PEB,but Im not sure how the two tests compare price wise.(as its clear that the CMS will step in if it feels the price is to high--even for the leading test at the time)
Obviously Abbott has continued with the test,so maybe they over priced it and are still turning a profit.
This obviusly puts the horse before the cart in terms of CMS as it has'nt happened yet for PEB,but how competitive (in terms of price)does an even better test still have to be?
Thoughts?
(I realize this is rather old news and if it has been thoroughly hashed over already, please excuse)
http://labsoftnews.typepad.com/lab_s...sion-test.html
A couple of weeks ago I posted a Genomic Health presentation, again here below,
http://files.shareholder.com/downloa...esentation.pdf
Genomic Health is generally seen as the business model to emulate in rolling out a high accuracy molecular diagnostic test assay, in their case primarily for breast cancer.
The breast cancer market is larger than the bladder cancer market at 234,000 cases per annum compared with 74,000 for bladder cancer. Thus, a market three times the size on that basis, although one can argue that more bladder cancer tests are performed on a per patient basis due to the very high recurrence rate of bladder cancer. And, of course in addition, Pacific Edge also have the haematuria screening market potential with Cxbladder(triage).
Genomic Health achieved Medicare coverage in 2006 for OncotypeDx, at which time their revenue jumped from $5.2M to $29M per annum within that year.
Some eight years later at FY14 their revenues were $276M, and they have recently advised a new goal of achieving $1B in revenues by 2020.
Genomic Health have achieved this by bringing to the market a diagnostic test which is better than the traditional methodologies that were previously used by clinicians, and, they have been able to break the glass ceiling to make their product a recognised mainstream form of care, rather than just an accessory.
So is this business model applicable to Pacific Edge and why don’t all diagnostic test companies achieve this level of growth ?
It seems to require a diagnostic product that ultimately can be demonstrated to have sufficient clinical utility which is capable of replacing the traditional status quo.
All the other diagnostic products in the bladder cancer space, other than Cxbladder(detect) fall short.
NMP22, Urovysion FISH, BTA and others are less accurate than the traditional methodologies, and thus will only ever be used as an adjunct, or as a supplementary test to cytology, with a firm capped glass ceiling on their market potential.
Cxbladder though, which is the only bladder cancer diagnostic test more accurate than cytology and which detects 100% of tumours of concern to Urologists, has the potential, just like OncotypeDX, to become a primary mainstream form of care.
https://www.nzx.com/files/attachments/209911.pdf
They also have tests for colon=133,000 and prostate=221,000---total 585,000--its a much bigger market,but there may be other factors.
Not sure how competitive they are price wise,or how much the price factors in.
Genomic Health also partners with leading companies developing oncology therapeutics to investigate and develop genomic-based testing to predict the likelihood of response to targeted therapeutics in various tumor types. The company focuses on increasing the value proposition of clinical treatment for patients through partnerships with pharmaceutical companies including sanofi-aventis, Bristol-Myers Squibb/ImClone Systems and Pfizer.
https://www.nzx.com/companies/PEB/announcements/262960
So the Triage study now published. You beaut, and congrats PEB.
Huge potential, not price sensitive apparently.
As this study crosses the desk of those that write the cheques for 80% of the worlds unecessasry initial workup cystoscopies; and comes to the attention of those poor sods that go through the trauma of that examination, I have to wonder at the likely effect on share price. Lets see..
$994k of shares were just traded off market - someone's a believer.