It has been touted on this thread that big pharma has a major influence and corrupt politicians can decide what the medical professionals can do and say; and, who will succeed and who will fail. It’s very hard to keep a secret in this world and whistle blower policies to protect informants are not just available in New Zealand. And, the clinical trial results and urological publications fairly and openly challenge the findings of all published material.
....(I think this argument against Pacific Edge by some is nothing short of absolute rubbish).
You shouldn’t be punished for doing the right thing. This is the law in many cases. For a century and half, Congress has offered certain whistleblowers both legal protection and monetary rewards — and lately it has expanded the incentives to report many types of wrongdoing.
HyperLink: American Whistle Blower Protection
It has been touted on this thread that Pacific Edge Limited need to take on a (big pharma) Joint Venture partner to have any chance at all of being successful in America. Well, the big pharma below aren’t having it all their own way either in the urological field, that’s for sure. The marketing program that Pacific Edge has in place was carefully prepared using independent consultants where necessary, and is being carefully implemented.
I think that investors may be slowly just starting to realise how much of an impact this upstart, back water company (PEB) is having in the urological world. Pacific Edge are giving urologists an opportunity to test drive via ‘User Programs’ the
CxBladder test. There has been a few tests around previously and there are a few on the horizon. The comparison graphic shows the performance of
CxBladder.
CxBladder Clinical Trial Test Result~1.
Attachment 7178
Urine cytology has been used
>60 years for the diagnosis of Urothelial Cancer and now it has the adjuncts of ‘Fluorescent In Situ Hybridization’ (FISH) and ImmunoCyt tests.
Abbott Molecular – UroVysion (FISH) Test.
UroVysion Fluorescence in Situ Hybridisation (FISH) assay. Medical Services Advisory Committee (MASC) - Australian Assessment - 2005
In general, under any plausible variation of evidence of accuracy, costs or rates of recurrence, the use of the UroVysion test remained more costly than current practice given the expected diagnostic pathways.
Recommendation: MSAC recommended that on the strength of evidence pertaining to UroVysion Fluorescence In Situ Hybridisation (FISH) assay public funding should not be supported for this procedure.
Australia & New Zealand Horizon Scanning Network - 2009
2009 HEALTHPACT Action: Tests including BladderChek® and UroVysion FISH assay, designed for the detection of bladder cancer in high risk patients, have poor sensitivity and poor positive predictive values. It is not recommended that these assays be used in asymptomatic patients but they may be useful in the monitoring of patients with transitional cell carcinoma between Cystoscopies. Therefore it is recommended that this technology not be assessed further.
Comparison of ImmunoCyt, UroVysion, & Urine Cytology in Detection of Recurrent Urothelial Carcinoma - 2009
Conclusion: UroVysion has a specificity that is comparable to Cytology in Cystoscopically negative cases. UroVysion may still have value as a confirmatory test for either Cytology or ImmunoCyt.
UroVysion, Urine Cytology, and the College of American Pathologists - 2010
UroVysion (Abbott Molecular) is an FDA approved test for the diagnosis of urothelial carcinoma. Although widely used, there are a variety of different ways to evaluate and interpret the test, and questions remain about the test’s cost effectiveness and reproducibility in actual clinical practice.
Evaluation of UroVysion and Cytology for Bladder Cancer Detection - 2013
Valid results of both UroVysion and Cytology examinations from the same urine sample. UroVysion tests were performed as per the manufacturer’s instructions.
Conclusions: UroVysion was more sensitive than Cytology in detecting UCC, but produced more false positive results. Our data suggest that the use of UroVysion as a reflex test following an ambiguous Cytological diagnosis may play an effective role for UCC detection.
Oh, and by the way, big pharma certainly didn’t manipulate this organisation.
CENTRES for MEDICARE and MEDICAID 2011
Abbott's molecular test, UroVysion, effective January 1, 2011. CMS has announced a separate code which covers that test and moreover appears to be aimed specifically at that test. The financial impact is dramatic, basically resulting in a 50% cut in Medicare reimbursement.
I would suggest that Pacific Edge are not taking it to the big boys at all; but, are just doing their own thing marketing a major shift in Bladder Cancer testing technology. Their professional, fully trained urological Account Executives are working with the clinicians to introduce this into their clinical pathways and this is being done by the 'User Program'. Now, that is called "putting your money where your mouth is"!
We shall see how the commercial roll-out is proceeding when the 2015 results are released. To comment now on the success or failure of the uptake of the
CxBladder test would be premature and based on totally unfounded information and thus would be a tad irresponsible.