I've been monitoring GBI from the sidelines since its float and...

I've been monitoring GBI from the sidelines since its float and have been interested in its progress to date. It's positive to see a small biotech hold firm in the tough market although I do have some opinions about its projected sales figures given by Decan and others on this forum.

First, I don't see the direct correlation between TGA/CE mark/FDA approval and sales. Digene/QIAGEN have had FDA approval since 2003 and thus been in a strong position to establish market dominance. I am aware that this test does not provide GBI's much-hyped genotyping, but that 'feature' is of limited clinical benefit. Further, Roche have a CE-IVD marked HPV genotyping test (Linear Array HPV Genotyping kit) available and it would be reasonable to say that there has not been very high demand for this product, and certainly not in the scale promoted by GBI and some contributors to this thread. In short, I fail to see that GBI's product offers anything new to the market.

Second, I am uncertain as to exactly whom GBI will be selling their product to, i.e. what is the real-world demand for their product. With DECANs projected price of $US15/test this GBI's product would be accessible only to first world countries. Many of these countries already have publicly funded pap-smear screening programs and/or are investing in HPV vaccination programs. I am aware that HPV DNA testing confers specific advantages over conventional pap screening but I agree with Liqcrisis' assessment in that it would be a brave public health official to deviate from the established (effective) screening programs. As such, potential customers would largely be limited to private patients requesting genotyping be performed at additional out-of-pocket expense. This is the current status of Digene/QIAGEN testing in Australia for women wanting the identification of high-risk HPV strains, as well as the Tam-Pap test for women wishing HPV genotyping be performed. I have tried to ascertain what the current and historic sales of Digene/QIAGEN and Tam-Pap testing are but have not had much luck. Anybody able to help? Again, I feel GBI's test does not offer substantive additional utility to those tests already available for women in Australia either through the free screening program or existing out-of-pocket genotyping tests.