Meridian Diagnostics Inc. announced Thursday that it hasreceived FDA go-ahead to begin marketing a new version of itsImmunoCard, a credit card-size device that performs rapid,individual enzyme immunoassay.
The new product detects the heterophile antibody producedduring infection by the Epstein-Barr virus that causesinfectious mononucleosis. The device can detect the presence ofthe antibody in about five minutes from whole blood, serum orplasma.
The new product is the latest addition to the Cincinnaticompany's ImmunoCard product line. A product that detectsClostridium difficile, a bacterium implicated in certaingastrointestinal disorders, was approved in February 1993.According to a Meridian representative, the company's currentdevelopment strategy involves the transfer of its Premierenzyme immunoassays into the smaller Immunocard format.
Meridian (NASDAQ:KITS) recently acquired two products forthe detection of mononucleosis -- Monoalert and Monospot --from Johnson & Johnson's Ortho Diagnostic Systems Inc., givingthe company a strong hand in this market. The companyestimated the annual market for mononucleosis testing at $16million worldwide. -- Karl Thiel
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