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Quidel Receives CE Mark for Its Direct Specimen Rapid PCR Test for Toxigenic Clostridium Difficile

Quidel Corporation announced today that it received CE mark for the Quidel Molecular™ Direct C. difficile Tox A/B assay for the detection of toxigenic Clostridium difficile bacterial DNA. C. difficile infection is frequently associated with antibiotic therapy and often causes diarrhea and inflammation of the colon.

"A recent study by the CDC suggested that nucleic acid amplification tests can be as much as twice as sensitive as enzyme immunoassays," said Dr. Timothy Stenzel, M.D., Ph.D., chief scientific officer of Quidel. "Preventing transmission of C. difficile by early and accurate detection in order to isolate and properly treat patients with Clostridium difficile infection is essential to reducing the overall disease burden."

This Quidel Molecular Direct C. difficile Tox A/B assay is part of Quidel's expanding line of molecular diagnostics products. The Quidel Molecular product line offers PCR reagent kits for use by molecular diagnostic laboratories with their existing thermocyclers. These reagents provide attractive features that include refrigerated storage (no freezer required), convenient ready-to-use reagents, a short time to result, and other benefits that favorably affect diagnostic test outcome.

The Quidel Molecular Direct C. difficile Tox A/B assay kit includes an extraction-free, three-step sample preparation process that requires no heat step, no timed step, and no centrifugation as an added benefit. This fast and easy direct-to-amplification procedure allows the assay to generate a result in less than 60 minutes by an efficient and economical method.

"Quidel is committed to providing a continuum of diagnostic products for key infectious diseases to meet the needs of various lab settings," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "This PCR assay, along with our CE marked AmpliVue assay and our cell culture-based Toxin Detection System for C. difficile will help meet the testing volume and resource needs of many different types of labs. In receiving CE Mark for our second molecular assay for C. difficile, we have expanded our molecular offering beyond respiratory infections."

The Quidel Molecular Direct C. difficile Tox A/B assay is Quidel's first assay with a streamlined stool processing procedure. It is available for sale in Europe. Quidel also sells other CE Marked molecular tests in the Real-Time PCR format for Influenza A+B, hMPV, and RSV + hMPV. This assay is Quidel's fifth molecular product offering in the last seven months to receive authorization to market in Europe.

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