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Quidel's CEO Discusses Q2 2012 Results - Earnings Call Transcript

Stocks in this article: QDEL

Our placement rate improved during the quarter which is encouraging given the low prevalence rate and customer interest in discussing flu this time of the year. Other assays for hCG strep and RSV are planned to follow shortly and we would expect by the first quarter of 2013 to have a menu of four tests in the United States and six tests in Europe with still others to follow throughout the year.

The other key near-term initiative is AmpliVue our handheld disposable molecular platform that combines isothermal amplification with traditional lateral flow detection. We received CE mark for our C. difficile product in March, completed U.S. clinical trials in the second quarter and have been building inventor for our European product launch in the fall. And then anticipated launch here in the U.S. before the end of the year. We expect assays for MRSA for blood culture confirmation, (inaudible) strep and is to follow shortly.

I’d like now to turn to the medium to longer term timeframe in terms of likely commercial impact. During the quarter we progress with the rest of our molecular program. We received CE mark for our direct specimen PCR assay for C. difficile in early and are conducting U.S. clinical trials now.

We completed U.S. clinical trials for our RSV and human Metapneumovirus assays. Our HSV and VZV assays remain a development in our on track inter clinical trial this half of 2012 with other PCR assays to follow shortly.

As I previously disclosed we are aiming to have a menu of 20 targets that can be run on our Wildcat platform when it launches in 2014, and at that this stage I remain confident that we can see that hurdle.

I should mention that we recently entered into a partnership with Life Technologies for the development and commercialization of real-time PCR assays on their new instrument system. Many of these assays will be portable to Wildcat as well. With respect to project Wildcat, specifically with development of the platform, we remain on track at this stage. Primary focus is ensuring that we keep our commitment to the Northwestern Global Health Foundation. That commitment is to develop and deliver an inexpensive fully integrated molecular platform that can reduce the cost of HIV viral load and TB testing in Africa in 2014. We believe that the key to achieving this goal is development of a low cost cartridge and that our proprietary (inaudible) extraction technology is the key to delivering on that promise.

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