*Warning this is a little long and I will not make a habit of giving you such an in depth in future*
I can't find anywhere either on the PLT website, from their ASX annoucements or the Intersuisse report that mentions genotyping so would assume that PLT's HPV test doesn't genotype. This is a significant marketing advantage and so if you could do it you'd let people know about it! This may go to explain why it was purcahsed for A$210k in PLT paper. The next generation of HPV testing is all about the ability to genotype.
With the rise of the vaccines, and with the billions that Gardisal (Merck/CSL) and Cervarix (GSK) are spending on promotion, the ability to genotype will win in the market as women increasingly ask not just do I have high risk HPV or not, but what types do I have? The vaccines only work against the 2 highest risk types 16 & 18 which cause 70-75% of all cervical cancer. Once a women finds out that by having the vaccine she's only protected against 70-75% intuitively one asks the question well what are the other types I have that put me at risk? It is sustained infection with the same high risk type of HPV that causes cervical cancer not being infected with high risk HPV per se. Hence the need for a test that genotypes. All sales and marketing really.
I've had a peruse of the Intersuisse PLT report and make the following observations (note I do not plan to address TruScreen as it is a different product for a different target market...ie. a product for the devleoping world where path infrastructure isn't large for which I have no real expertise)...I will note from the data presented on page 2 of the Intersuisse report that, like HPV testing, at present the data suggests that Truscreen is best used as an adjunct procedure alongside a traditional Pap...70% accuracy versus 93% as a combination for detection of CIN 2/3 and even a greater spread for detection of CIN 1). I note that the data doesn't mention figures for 'specificity' of the TruScreen as a standalone or as an adjunct to Pap.
Traditional Pap (1st generation) actually now sells (retail) for about $15 to $18 not $25 to $30. 2nd generation is dominated by ThinPrep, LBC (liquid based cytology) pioneered by Cytyc (65% of all Pap in the US at present) and they sell this for about US$6.50 in the US and US$5.00 in Europe and US$5.50 in ROW (see link to Morgan Stanley summary model that I have very generously provided...the Intersuisse analyst who could not get the sales of ThinPrep for his report did not look hard enough). Note that this model/report is from 2006 as Morgan Stanley pretty much stopped publishing research in late 2006 and 2007 as its bankers were advising the company on various M&A deals.
Looking at the Intersuisse analyst's figures re retail cost of LBC, around US$60 to US$70 is about right (this also shows the margin that pathology companies and physicians make versus the $5.50 selling price from Cytyc, highly profitable for path labs). LBC is the way to go with collection of cervical samples as it provides a significant benefit over the old dry smears taken with a spatula and put onto a slide and sent away to the cytologists at a path lab!
The Intersuisse report talks about 3rd generation tests being Roche's Amplicor and Digene's Hc2. These are high/no risk HPV tests. Digene's ASP in the US is US$21 with average reimbursement throughout the US at US$49. Digene has 95% of the regulated market at the moment (note that a substantial 'home brew' market also exists in the US). Roche's Amplicor product is substantially more expensive but it can genotype as well (30+ types and this is 4th generation...when bundled with its Linear Array)...cost of the bundled product is approx US$100-US$125. Another genotyping test (16 & 18 only) is Thirdwave Technologies Inc. Thirdwave's is expected to sell at parity to Digene's Hc2 (say US$20). See links to Thirdwave report and Digene report kindly attached. Both provide a great background on HPV testing.
Digene is also developing its Hc4 test that also genotypes (but only high risk types 16 & 18). Digene plan to sell this test as a follow up test after a woman tests positive to HPV via Hc2. Both Roche and Thirdwave are still pending FDA approval and Digene's Hc4 will probably get approval in 12 to 24 months.
Note that an LBC test is different from an HPV test. The Cytyc LBC test is a collection method with an automated screen for cell abnormality not the presence of HPV! Cerviscreen is a bundled product, being a self sampling device and a HPV test (generation 3, I assume).
Intuitively, I understand the pro's of self sampling but one would need to generate the clinical data in concert with an HPV test to get this finally approved in the developed world...this may be attractive to a new HPV company commencing their clinical trials as one may be able to kill 2 birds with 1 stone here, however I would add that the risk for the HPV company would be increased using a 'non-approved' collection device in their trials. From an economics perspective however, the trade off re risk of using an unapproved collection device could be weighed against effectively doing one clinical trial (pretty much a fixed cost) and getting 2 products approved by the FDA (the self sampler and the HPV test...an interesting concept).
I will also add that in the interim in the developed world when you are taking away margin from the physicians (ie. look at the margins in the ThinPrep unit costs versus the US$60 to $70 retail cost) you may experience some degree of push back. The only reason they charge a margin here is that they take the sample not just hand over a via and a brush and vial to the patient. Pricing and overall profit to a physician would have to be carefully considered here. You would need to educate physicians that more women would come for a Pap if they self sampled, and it would take (on a net basis), less of a physicians time but generate more revenue, then you would be a long way there. You would also have to establish reimbersement in the US which takes considerable time and money.
In short, in bringing a self sampling device to market you need to try to keep all the incumbents happy re the money that they currently earn!
Finally it says that Digene's test can be used as a self sampling test, yes true, but I would say barrier to adoption and cost in getting approval here is high . Key with self sampling adoption is still patient education and getting women into the physicians rooms to then take their own sample, you still need to get them in, this is purely a marketing exercise that is going to take serious marketing dollars!
Anyway probably too much information and a lot of verbage that's irrelevant but some of my thoughts.
cheers
PS...I note that Intersuisse's valuation didn't take into account the dilution of the C-Notes for their per share valuation, bit of a worry re the credibility of the analyst...you certainly could never get rated in the US if you made such a elementary mistake!
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