There have been a few posts about the repetitious mention of User Programs and some posts of a threat by the so-called Big Pharma Mafiosi.
There are actually a few good reasons why the ‘User Programs’ are an excellent way of marketing your product. The most important is that the Urologists and Clinicians over the years have been subject to a myriad of articles about procedures, tests, tools and instruments, software, business aids and charts that companies have been flogging off, the range is staggering and they may now be a sceptical about claims made.
If the Urologists and Clinicians could just browse the aisles of Wee Wees ‘R’ US, then they may be able to handle the product and read the box. This is not the case; and, there is also the issue Pacific Edge identified of Customer Pre-Purchase Dissonance.
NOW, the test kits themselves do not cost a lot to produce ~$US20 and the Urologists use of the kits means that their process will change to a certain extent, so the user program allows the vendor to market the whole kit and caboodle, which is obviously well received due to the number of programs that have been signed up. So, it is not just a matter of snake oil salesmen trying to hock off grandpas secret remedy.
The companies receiving the product and process are the beneficiaries of a financial and intellectual commitment from Pacific Edge, and the evidence of the success of the user programs means that the product and changes to their process are well received and they end up signing supply contracts with Pacific Edge Diagnostics. This process also bypasses Big Pharma and the likelihood that there are any stand over tactics (if this is really an issue, I do not believe it happens) are mitigated.
Cxbladder is the product that is now being marketed that far exceeds anything that has been marketed previously in the way of accuracy (specificity and sensitivity) that can replace Cytology and be used to limit the number of Cystoscopies.
We know that CertNDx bladder test was removed from market because it only indicated a possible issue and was a poor test. Cytology and NMP22 were good tests and were compared to
Cxbladder in the clinical trials.
Hyperlink: Cxbladder Clinical trial Results
Here is a summary of the other tests and their limitations (if any) available to urologist, none come close to
Cxbladder for accuracy, utilisation and ease of use, so the future is very promising and the User Programs are a very very smart way to market.
- The BTA (bladder tumour antigen) stat® test, (Polymedco Inc., Cortlandt Manor, NY) is a qualitative, point-of-care test with an immediate result that identifies a human complement factor H-related protein that was shown to be produced by several human bladder cell lines but not by other epithelial cell lines.
- The BTA stat® test is an in vitro immunoassay intended for the qualitative detection of bladder tumour-associated antigen in the urine of persons diagnosed with bladder cancer. The BTA TRAK® test (Polymedco Inc., Cortlandt Manor, NY) provides a quantitative determination of the same protein. This test requires trained personnel and a reference laboratory. Both tests have sensitivities comparable to that of cytology for high-grade tumours and better than cytology for low-grade tumours.
- Nuclear matrix protein 22 (NMP-22) is a protein associated with the nuclear mitotic apparatus. It is thought that this protein is released from the nuclei of tumor cells during apoptosis. Normally, only very low levels of NMP-22 can be detected in the urine, and elevated levels may be associated with bladder cancer. NMP-22 may be detected in the urine using an immunoassay.
- Fluorescence in situ hybridization (FISH) DNA probe technology has also been used to detect chromosomal abnormalities in voided urine to assist not only in bladder cancer surveillance but also in the initial identification of bladder cancer. FISH DNA probe technology is a technique to visualize nucleic acid sequences within cells by creating short sequences of fluorescently labeled, single-strand DNA, called probes, which match target sequences. The probes bind to complementary strands of DNA, allowing for identification of the location of the chromosomes targeted. UroVysion® (Vysis Inc., Downers Grove, IL) is a commercially available FISH test.
- The ImmunoCyt™ test (DiagnoCure Inc., Quebec) uses fluorescence immunohistochemistry with antibodies to a mucin glycoprotein and a carcinoembryonic antigen (CEA). These antigens are found on bladder tumor cells. The test is used for monitoring bladder cancer in conjunction with cytology and cystoscopy.
- In addition to the FDA-cleared tests, Predictive Biosciences (Lexington, MA) is marketing a urine-based test, called CertNDx TM, to assess Fibroblast Growth Factor Receptor 3 (FGFR3) mutations. The test is intended to be used in combination with cytology for identifying patients with haematuria at risk of bladder cancer. It is being offered through Predictive Bioscience’s network of Clinical Laboratory Improvement Amendment (CLIA) laboratories. FGFR3 mutations may be associated with lower-grade bladder tumours that have a good prognosis. (now removed from market)
So as you can see we have an exciting product that will rock the urologists and clinicians world in my humble opinion.