gbis projected sales, page-3

A2G, I hope you’re not DECAN appearing as Dr. Jekyll after Mr. Hyde.

I would agree that TGA or FDA approval is no guarantee of market success but they are vital, just to get access to the market in the first place. A tick of approval from the regulators does also give confidence in the technology.

At $15US a test the third world is not currently a market for the GBI assay, which will be most likely to be dominated by the Qiagen/ Bill and Melinda Gates, CareHPV assay. I think from history the only way to make money in the third world is to pinch there resources and sell them rusty guns.

GBI is going after the developed nations markets. TGA and CE mark approval will allow access to Europe, which will be tough market with a lot of large and small players already established.

As for America GBI,quite rightly, has not gone after an FDA application which is beyond the companies resources.
I do question the idea that FDA approval would be taken up by a potential buyer of GBI. It would take at least 2-3 years for a buyer, who would pretty much be starting from scratch, to get FDA approval and in the interim the hybridisation technology used by GBI and others is getting old.
Advances in sequencing, for example, are rocketing along at a rate faster than “Moore’s law” for computer chips, and I think will very soon, make definitive tests like diagnostic sequencing competitive in price and speed with RT-PCR or hybridisation.
So I think it would risky for a company to go through the expense of an FDA application for technology which could be superseded even before being approved.