Friday, August 27, 2004

Meridian wins FDA approval for colitis test

By John Byczkowski
Enquirer staff writer

Meridian Biosciences Inc. of Newtown has received FDA approval to begin marketing a faster test kit for detecting bacteria that cause severe colitis, the company said Thursday.

Colitis, an inflammation of the bowel, is common among hospital patients who have received intravenous antibiotic treatments or immunosuppresssing drugs.

"Somebody who begins to produce symptoms must be tested and their therapy switched very quickly," said Meridian president John Kraeutler.

Meridian's new kit detects the toxins produced by C. e, the bacterium that causes colitis in these patients. Test results are available in minutes, while the company's existing test kit takes two hours.

"Treatment decisions can be made quickly, leading to faster patient recovery," he said.

Demand in Europe for the new kit has outstripped Meridian's manufacturing capability, Kraeutler said. Meridian expects to begin marketing the new kit in the United States in 60 days.

Meridian is already a leader in diagnostic kits that detect causes of colitis and diarrhea, Kraeutler said. "Early indications are (the new kit) is going to be a very important product," he said.

Meridian stock closed at $11.70, down 24 cents, in trading Thursday.


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