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Meridian Bioscience’s Campylobacter test cleared

This article was originally published in The Gray Sheet

Executive Summary

Firm will launch its Premier Campy test for detection of Campylobacter infection this week after receiving FDA clearance on Feb. 4, according to a company spokesman. The test launched in Europe in December 2008. Campylobacter infections are the most commonly diagnosed bacteria for food-borne illness in the U.S., and are most often caused by poorly cooked poultry. Around 20 million screens for the bacteria are conducted in the U.S. each year. Meridian says its antigen measuring test is more accurate than the Campylobacter bacteria culturing process, which can be less sensitive due to variable culturing procedures, specimen viability and inhibitory antibiotics in culture media

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