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Meridian Gets FDA Nod for New Campylobacter Test - Update

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us
rttnewslogo20mar2024

Medical diagnostic test kit maker Meridian Bioscience, Inc. (VIVO), Wednesday revealed Food and Drug Administration clearance for its novel rapid test, ImmunoCard STAT! CAMPY to detect Campylobacter.

Campylobacter bacteria is one of the common causes of diarrhea and food-borne illness in the U.S, where about 20 million stool culture tests are done every year to diagnose Campylobacteriosis.

Meridian said that ImmunoCard STAT! CAMPY, by means of a simple procedure, could provide results in 20 minutes. The testing technique is also free from the problems associated with the presently used method of culture testing.

With culture, there is a potential for reduction in sensitivity due to variable culturing procedures, specimen viability, and inhibitory antibiotics in culture media. ImmunoCard STAT! CAMPY is indicated to significantly reduce such concerns with a consistent method that measures the bacterial antigen instead of measuring the viability of the fragile bacteria in an environment.

John Kraeutler, Chief Executive of the company said, "ImmunoCard STAT! CAMPY is a significant addition to our foodborne category because it provides laboratories with a rapid, accurate and easy to perform platform for the detection of Campylobacter."

VIVO is currently trading at $19.37, down $0.06 or 0.31%, on the Nasdaq

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