FDA Approves VIVO Diagnostic System – Analyst Blog

Recently, Meridian Biosciences (VIVO) received approval from the U.S. Food and Drug Administration (FDA) for its molecular diagnostic system, “illumigene C. difficile“, to diagnose serious and infectious diseases.

 

The molecular diagnostic system was recently launched successfully in Europe in the first quarter 2010. Its approval in the U.S. expands the company’s existing portfolio of molecular diagnostic assays further, now catering to the needs of both the domestic and international customers.

 

Meridian Biosciences is an integrated life science company that engages in the development, manufacture, sale, and distribution of diagnostic test kits, primarily for respiratory, gastrointestinal, viral, and parasitic infectious diseases.

 

Within Meridian Biosciences’ U.S. and European diagnostic segments, sales of C. difficile products decreased 29% year over year during the first quarter of fiscal 2010 and were flat during the second quarter of fiscal 2010. Sales were affected by the distributor-buying pattern as well as due to the stiff competition faced for such products.

 

Meridian Biosciences reported a 1% year over year decrease in the research and development expenses for the US Diagnostics operating segment to $2.3 million in the second quarter, primarily due to the decrease in development costs associated with the molecular diagnostic system. Further, the increase in the cost related to the illumigene launch led to an increase in the selling and distribution expenses by 7% year over year in the second quarter.

 

Meridian Biosciences expects to combat competitive pressures with its strong position in toxin testing and with the newly launched molecular amplification assay, which is simple to use, cost effective and easily accessible for the customers.