IVDT_In Vitro Diagnostics Technology

IVD Technology, Spring 2013

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facturers out there, but one needs to fnd one that has experience developing molecular diagnostics, bringing CE-marked and FDA-cleared products to market, and bringing kits to a format that will be suitable for the market. It has not been easy, but we believe we have identifed a company that will be able to deliver all of that for us. we had gone through a bit of a learning process fling in Europe frst, it was relatively smooth and simple [to fle in the United States]. So, we were very pleased with that, and obviously when one is looking to investors, it adds signifcantly to the value of the company—to the IP that we possess. Can you talk about how obtaining the CE mark fgures into your process? Tat is tied to the whole manufacturing process. CE marking for this test is a self-certifcation process for which one has to produce the necessary documentation and design fles, and then produce a self-certifcation for that product. For this class and level of product, it's not as strict as what American companies might be used to [when submitting a] 510(k) or PMA in the United States. Tat's one of the reasons why even a lot of U.S. companies these days are bringing out CE-marked products before seeking FDA clearance. We have an exclusive global license for the meningitis test. We also, and just very recently I must add, were granted a patent in the United States for the meningitis test, which is a wonderful achievement. We fled in Europe a while ago, and the European patent is still pending. We used what we learned from our experience in the United States, and I have to say, because Things seem to be going well for HiberGene. Has there been any part of the meningitis-test development process that was challenging? We've got the global license to the test, we've identifed our instrument partner to go along with this test, we've been granted a U.S. patent for this test, we have a business plan in place, we've got a corporate fnance partner on board, and we're going out to our investment team with this model. Te proof of the pudding will be once we get the necessary funding on board, so that we can then get the test to market and bring the additional tests on behind it. I would say, so far, so good. Te next major next step is raising the funds. We believe we've got a very robust model: the product is near commercialization; distribution channels are identifed and onboard; the manufacturer is identifed; we have a proven technology platform in place; we've got the right management team onboard; and we have a clearly defned market strategy. And, we believe, HiberGene provides a very good investment opportunity. IVD WHEATON ® High Recovery Vials NextGen™ V Vials® E-Z Ex-Traction® Vials Conical interior provides downward drainage for maximum sample retrieval Clear vials conform to USP Type I and ASTM E 438 Type I, Class A requirements Excellent for chemical compound or biological sample storage Vials can be easily bar coded using WHEATON Customized Services www.wheaton.com 800.225.1437 ivd tech n o lo gy.com magenta cyan yellow black I VD T EC H N O LO G Y | S PR I NG 2 0 1 3 1 5 ES235846_IV1305_015.pgs 04.23.2013 05:08 UBM

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