IVDT_In Vitro Diagnostics Technology

IVD Technology, Spring 2013

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IN PERSON go out there via distributor networks, principally in Europe and the United States. We're focusing on the fve major European markets—Germany, France, UK, Spain and Italy—plus the United States. At Innogenetics and OraSure, we built up distributor networks for novel testing platforms, mainly for the OraQuick HIV test at OraSure. I have a lot of experience building out distributor networks that bring novel products to market. What are HiberGene's target markets for the bacterial meningitis test? In Europe, our target market will be small and mediumsized hospitals. For tests like meningitis, one can also see an application in emergency labs and in larger children's hospitals, where they would likely want access to a quick, very reliable, and very accurate test for meningitis. In the United States it would still be the small to medium-sized hospitals. We believe there are around 4000 hospitals that utilize an outside lab service for molecular diagnostics, so that's going to be a big part of the target market. In addition, there are around 20,000 physicianofce laboratories that are CLIA-defned to perform medium to complex testing that we believe we'll be able to access. Our business plan is built on selling to Europe and the United States. Of course, we also recognize there are many developing markets. Obviously, as a small start-up company, we need to focus our eforts. But, these additional markets will ofer an opportunity for us to explore and develop as we go forward. And that will depend upon, frst, the size of the market, and second, the regulatory hurdles of getting into those markets. We are approached almost daily by distributors and potential customers in a lot of additional markets. HiberGene sourced an instrument platform from a contract manufacturer to support the meningitis test. clearance, and in our modeling we put our products in the United States at about one year after the European introduction. With the meningitis test, we're planning to launch that in Q4 of this year, and we'd probably see that hitting the U.S. market sometime around Q4 of 2014. Is that unusual, to be approached daily like that? It is somewhat unusual that they approach us like this, but again I think it demonstrates the strength of our proposition. Meningitis in itself is quite an urgent topic. It's one for which there is a clear and unmet need for testing today. Meningitis is not the biggest infectious-disease testing market in the world, but we have a range of 16 additional infectious-disease tests coming along behind that, in a very short period of time, that will be able to utilize the same instrument platform. Are you focusing primarily on the bacterial test frst, then following up later with the viral test? Yes. Te reason is that viral meningitis doesn't have the same signifcance in terms of patient infection. Bacterial meningitis causes severe symptoms and can lead to septicemia, limb loss, and ultimately death if not treated in the right manner and quickly enough. Tat is what we are focused on most. Te beauty of our business model is that we are utilizing a common and very well-tested and proven technology platform. Te technology platform that we have will allow us to develop tests for a wide range of target organisms. Following meningitis, we will be launching products for pneumococcus, which is another bacterial form of meningitis, and GBS— Group B streptococcus. We anticipate that they would follow probably six months after launch of the bacterial meningitis test. Beyond that, we've identifed a range of sexually transmitted infections, hospital-acquired infections, respiratory pathogens, and others that we can develop using this platform and that will be suitable for a rapid and easily accessible molecular diagnostic test. What are your plans for commercializing the meningitis test in the United States? We suspect that the U.S. program will be about one year behind the European program. As I mentioned, we are focusing on the big fve countries in Europe, building out distributor networks there. Our products will be CE-marked for Europe, but obviously in the United States we're looking for 510(k) FDA Please talk about the process of fnding a manufacturer for your test. We've begun a process with a UK-based company that we would look to continue with. If not them, it will be another European-based contract manufacturing company. It's not particularly complicated, but one needs to fnd a manufacturer that has the needed level of expertise in producing a molecular product. Tere are many conventional diagnostics manu- 14 IVD TEC HNOLO G Y | SP RIN G 2013 magenta cyan yellow black i v d t e c hnol ogy. com ES235842_IV1305_014.pgs 04.23.2013 05:08 UBM

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