Quidel Receives FDA Clearance for Its AmpliVue(R) Hand-Held Molecular Diagnostic Test for Clostridium Difficile

Quidel Corporation, a leading provider of rapid diagnostic testing solutions and cellular-basedvirology assays, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the sale of Quidel's non-instrumented molecular diagnostic test -- the AmpliVue C. difficile Assay -- for the detection of toxigenic Clostridium difficile bacterial DNA. Detection of the pathogen is achieved using a hand-held, fully contained cassette that combines isothermal Helicase Dependent Amplification (HDA) with its lateral flow detection technology.

C. difficile infection is frequently associated with antibiotic therapy and prolonged hospital stays. Typical symptoms include nausea, fever, watery diarrhea and abdominal pain due to inflammation of the colon.

Clostridium difficile bacterial infections can be life threatening, especially for the elderly, for the immunocompromised, and for patients on a prolonged antibiotic regimen. "According to the Centers for Disease Control and Prevention, C. difficile causes diarrhea linked to 14,000 deaths in the U.S. each year," said Dr. Timothy Stenzel, M.D., Ph.D., chief scientific officer for Quidel, who added "for this reason, accurate and fast diagnosis -- like that provided by AmpliVue -- is vital to the patient's proper treatment and recovery."

Traditional methods for diagnosing C. difficile infections, such as glutamate dehydrogenase (GDH) or toxin antigen tests, can lack sensitivity and increase lab costs due to additional confirmation testing. In addition to significant technical expertise, cytotoxicity assays and toxigenic culture require 24-48 hours and 3-5 days, respectively, before reliable results can be obtained. The AmpliVue C. difficile Assay will now enable laboratories to offer a fast and sensitive result generated by molecular methods using actual kit components, without the need to purchase and maintain expensive capital equipment. The assay also requires no upfront nucleic acid extraction step.

"We are very pleased to receive 510(k) clearance for the first hand-held molecular device for C. difficile," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "The AmpliVue C. difficile Assay will allow hospitals currently using traditional detection methods to employ a more sensitive, rapid molecular test, thereby providing laboratory technicians and the physicians they serve with accurate, timely, and reliable diagnosis of C. difficile infections."

The C. difficile assay is Quidel's first assay in the hand-held AmpliVue format, and is now available for sale in the U.S. and Europe.