FDA OKs Meridian C. difficile Test

Diagnostic test kit maker Meridian Bioscience (VIVO - Snapshot Report) has clinched the approval of U.S. Food and Drug Administration (“FDA”) for its new C. difficile (Clostridium difficile) test dubbed Premier C. difficile GDH. The approval of this next-generation test broadens the Cincinnati-based company’s portfolio of C. difficile tests and underscores its sustained commitment to bring out breakthrough products for the detection of C. difficile. Premier GDH has been marketed in Europe since October 2010.

C. difficile is a highly drug-resistant bacterium which exists in the environment in spore (or inactive) form and produces a toxin that causes diarrhea and more serious intestinal conditions such as colitis. C. difficile spores are frequently found in hospitals, nursing homes and extended care facilities. Although spores cannot cause infection directly, they transform into the active (or infectious) form when ingested.

The prevalence of C. difficile has been growing at a brisk rate over the past few years. Study reveals that more than 7,000 patients in the hospital setting are being affected by C. difficile each day with an estimated associated healthcare cost ranging between $18 million and $52 million per day.

Premier GDH has been designed for detecting a common antigen produced by the toxigenic and non-toxigenic forms of C. difficile bacteria. The toxic forms of the bacteria are generally associated with hospital and community-acquired diarrhea and can cause a life-threatening inflammation of the colon. Premier GDH is intended for use by clinical laboratories for screening patients with diarrhea for both these forms of C. difficile.

Meridian specializes in developing diagnostic test kits for multiple serious and infectious diseases. The company launched its first GHD test, the ImmunoCard C. difficile GDH, in 1993. Moreover, Meridian secured the FDA clearnce to market illumigene, its first molecular test, in July 2010.

Meridian is expecting a rebound in 2011 from a beleaguered fiscal 2010 which was hit by a dreary influenza season, stiff competition in its C. difficile diagnostic business and a soft economy. Its diagnostics business faces strong competition from Abbott Laboratories (ABT - Analyst Report), Becton, Dickinson and Company (BDX - Analyst Report), Thermo Fisher (TMO - Analyst Report) and Siemens (SI - Analyst Report).

The company hopes sales in fiscal 2011 will be boosted by illumigene and its diagnostic test kits for detecting bacteria like C. difficile and H. pylori. The illumigene molecular test platform, which represents Meridian’s response to growing competition, is expected to be its principal growth engine in the coming years.