OraSure Technologies, Inc. (OSUR) Deutsche Bank AG Health Care Conference Call May 7, 2012 8:40 am ET Executives Douglas A. Michels – President and Chief Executive Officer Ronald H. Spair – Chief Operating Officer and Chief Financial Officer Presentation Unidentified Analyst
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We’ve also been investing very heavily over the last several years into real exciting new opportunities, one of which is the development of a rapid test for hepatitis C. That product is fully developed. We developed it on the very same platform that our market rapid HIV test has been developed and has been very successful.We believe that the market opportunity here in the United States for rapid hepatitis C test is in excess of $250 million. This test is now FDA approved. It’s the only rapid test for hepatitis C that’s CLIA waived and FDA approved here in the United States and we are in the midst of a launch of that product and I’ll talk a little bit more about that later on in the presentation. In addition, over the last six or seven years, we’ve been investing in clinical studies which would ultimately lead to FDA approval. Although, our rapid HIV test produced by consumers per se OTC in retail pharmacies and in mass retailers across the United States. We believe the market opportunity for on a self test or HIV sold OTC is an excess of $500 million. We’ve been working on this like I mentioned for quite sometime. We have a very exciting event coming up a week from tomorrow and in Hattiesburg, Marlin where we’re going to present our final clinical data to the Blood Product Advisory Committee and we look forward to having that discussion with them and our hope is that that will ultimately lead to a positive recommendation and ultimate approval of this product and then obviously subsequent commercialization. Let me make a couple of comments about our market-leading position in rapid HIV testing. This is our current flagship product or a quick advance. It’s a rapid $20 million test for HIV-1 and 2, it is the only FDA approved and clear way of rapid test here in the United States that can be used with both a blood sample and an oral specimen. The product has been FDA approved and clear wave since 2002 and it is the market-leading rapid test here in the United States. We sell the product primarily into hospitals and into the public health systems where we have leading shares and we sell this product directly. So we have a direct sales force that calls on public health, as well as hospitals.
This is just a graphic of the competitive environment here in the United States. There is five other companies that market FDA approved rapid test and what we try to highlight here is the primary reasons why our product has been chosen as the preferred product in those markets in which we currently participate. I mentioned our [testing] has the ability to identify both HIV-1 and HIV-2 the product is clear waved, which is very important and that it enables the product to be used in a physicians office or in a distributed environment like so many public health jurisdictions use the product and as I mentioned it’s the only product that’s approved for use with both on blood specimen and in oral specimen and if that oral application that we’ve conducted our clinical studies on and that we intend to make available OTC assuming FDA approval.Let me talk a little bit about this because this is an effort that we began back in 2005, when we initially approach the FDA with our thought of taking our professional product and making the very same product available for sale to consumers. We went to an Advisory Committee meeting in November of 2005 and again in March of 2006 and through those meetings there was a decision that indeed the FDA should work with sponsor companies to bring a product like this to market and in the March meeting we agreed with the FDA on the clinical studies protocols that would be executed that would ultimately lead to approval. Read the rest of this transcript for free on seekingalpha.com