News ReleaseView printer-friendly version
Quidel Receives FDA Clearance for Its AmpliVue(R) Hand-Held Molecular Diagnostic Test for Clostridium Difficile
Dec 17, 2012 (Marketwire via COMTEX) -- Quidel Corporation (NASDAQ: QDEL), a leading provider of rapid diagnostic testing solutions and cellular-based virology 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,"1 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.
About Quidel Corporation
Quidel Corporation serves to enhance the health and well being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the QuickVue®, D3® Direct Detection and Thyretain® leading brand names, as well as under the new Sofia® and AmpliVue® brands, Quidel's products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, influenza, respiratory syncytial virus, Strep A, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel's research and development engine is also developing a continuum of diagnostic solutions from advanced lateral-flow and direct fluorescent antibody to molecular diagnostic tests to further improve the quality of healthcare in physicians' offices and hospital and reference laboratories. For more information about Quidel's comprehensive product portfolio, visit quidel.com and Diagnostic Hybrids at dhiusa.com.
This press release contains forward-looking statements within the meaning of the federal securities laws that involve material risks, assumptions and uncertainties. Many possible events or factors could affect our future financial results and performance, such that our actual results and performance may differ materially from those that may be described or implied in the forward-looking statements. As such, no forward-looking statement can be guaranteed. Differences in actual results and performance may arise as a result of a number of factors including, without limitation, seasonality, the timing of onset, length and severity of cold and flu seasons, the level of success in executing on our strategic initiatives, our reliance on sales of our influenza diagnostic tests, uncertainty surrounding the detection of novel influenza viruses involving human specimens, our ability to develop new products and technology, adverse changes in the competitive and economic conditions in domestic and international markets, our reliance on and actions of our major distributors, technological changes and uncertainty with research and technology development, including any molecular-based technology, the medical reimbursement system currently in place and future changes to that system, manufacturing and production delays or difficulties, adverse actions or delays in product reviews by the U.S. Food and Drug Administration (the "FDA"), our ability to comply with FDA, environmental and other regulations, our ability to meet unexpected increases in demand for our products, our ability to execute our strategy, including the integration of new companies or technologies, disruptions in the global capital and credit markets, our ability to hire key personnel, intellectual property, product liability, environmental or other litigation, potential required patent license fee payments not currently reflected in our costs, adverse changes in our international markets, potential inadequacy of booked reserves and possible impairment of goodwill, and lower-than-anticipated acceptance, sales or market penetration of our new products. Forward-looking statements typically are identified by the use of terms such as "may," "will," "should," "might," "expect," "anticipate," "estimate," and similar words, although some forward-looking statements are expressed differently. The risks described under "Risk Factors" in reports and registration statements that we file with the SEC from time to time should be carefully considered. You are cautioned not to place undue reliance on these forward-looking statements, which reflect management's analysis only as of the date of this press release. We undertake no obligation to publicly release the results of any revision or update of the forward-looking statements, except as required by law.
Chief Financial Officer
Media and Investors Contact: