FDA OKs Meridian's GDH Test

Diagnostic test kit maker Meridian Bioscience (VIVO - Snapshot Report) recently won the approval of the U.S. Food and Drug Administration (“FDA”) for its new C. difficile (Clostridium difficile) test dubbed ImmunoCard C. difficile GDH. The Cincinnati-based company launched the test in Europe in August 2011.

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 a hospital environment are prone to infection by C. difficile each day with an estimated associated healthcare costs ranging between $18 million and $52 million per day.

ImmunoCard C. difficile GDH is geared to detect a common antigen, known as Glutamate dehydrogenase (“GHD”), 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. The new, highly-sensitive test is intended for use by clinical laboratories for screening patients with diarrhea for 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. Meridian’s 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 U.S. approval and launch of ImmunoCard C. difficile GDH underscores the company’s sustained commitment to bring out breakthrough products for the detection of C. difficile.