Clinical trials for the illumigene C. difficile test were conducted at five sites. The trials have now been completed successfully and the data has been analyzed. The 510(k) for FDA marketing clearance in connection with Meridian ™s illumigene C. difficile product will be filed with the FDA on or about March 22, 2010. Shortly following the FDA submission, this new, simple to use molecular amplification product will be launched in markets outside the United States early in the third quarter. The illumigene molecular-based platform will be an important, new and complementary technology for diagnostic tests to be introduced in the future. illumigene is based on DNA amplification utilizing the loop amplification (LAMP) technology.

Fiscal 2011 Preliminary Outlook

As is customary, Meridian expects to provide its net sales and earnings guidance in late August or early September following its formal business planning exercise for fiscal 2011. However, based on current business trends and outlook, as well as expected new product development and introductions, including illumigene, management intends to provide a preliminary outlook on fiscal 2011 following the international launch of illumigene scheduled for April 2010.

Company Comments

John A. Kraeutler, Chief Executive Officer, said, To date, the second quarter of fiscal 2010 has been a disappointment. The lack of a respiratory season greatly slowed the momentum that we had been building in our new TRU FLU?® and TRU RSV?® testing products. We believe that, due to the abrupt end to the H1N1 pandemic, lab and distributor inventories of these types of rapid flu tests are higher than normal and that this may impact purchases ahead of the next season. C. difficile revenue growth slowed in the first quarter; however we expected a rebound in the second quarter without the distraction of swine flu testing demands. This market has been chaotic due to increased competition from traditional immunoassays and from newer molecular methods as they attempt to take share from existing technologies. Our response will be the launch of illumigene C. difficile. The results from our clinical trials exceeded our expectations for the technology's performance and the simplicity of its workflow will make illumigene an ideal technology platform for the infectious disease lab. Going forward, we will continue to invest in the growth drivers of the business as we continuously address opportunities for upgrading our capabilities. Our balance sheet is solid and cash flow is strong. We have accelerated our efforts to identify and investigate potential acquisitions that fit our long-term growth strategies. Costs are under close control as we continue to look for ways to improve manufacturing and other efficiencies. As we look forward to the balance of fiscal 2010 and beyond, the focus will be to improve sales and marketing effectiveness, bring the illumigene platform to market, and develop new products."