My understanding is that Gribbles sales are immaterial at this stage...in Australia HPV testing enjoys only a very limited scope of reimbersement as recommended by the Medical Services Advisory Committee (MSAC).
As it curently stands MSAC has only recommended that HPV testing be reimbersed in cases after a woman is treated for high-grade intraepithelial abnormalities of the cervix, in other words not as a general screening tool. This significantly limits sales volumes in Australia
What is important in the Gribbles deal is that it demonstrates that the PapType test can be used in a profitable manner in a commercial pathology setting.
Other pathology players like Sonic could also offer PapType if they too validated the test internally to NPAAC guidelines, however due to the lack of adequate reimbersement at this point they may choose to wait.
The US however is a different story as reimbersement is widespread throughout all 50 states and hence the attractiveness for them to internally validate the test over there is much greater as potential revenues are far more. Average reimbersement in the US for HPV testing is about US$43 and currently in the US about 25% of women who should have the test do so.
Expect IUO sales to commence in the US in 2009 after GBI has its manufacturing in place under GMP and receives ISO 13485 accreditation. Full regulatory EU approval should be received in mid 2009 which will facilitate sales through out Europe and parts of Asia (ex Japan). TGA approval for Australia should also be received around the same time also. Outside of the US, Germany, Switzerland France and the UK provide the greatest opportunities for HPV testing.
Finally, there is a fair liklihood that MSAC will change its stance on reimbersement for HPV testing as a screening tool by the end of 2009. Once this occurs, this will broaden the Australian market opportunity significantly.
GBI Price at posting:
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