News ReleaseView printer-friendly version
Quidel Receives CE Mark for Its AmpliVue(TM) Hand-Held Molecular Diagnostic Test for Clostridium Difficile
SAN DIEGO, CA, Mar 27, 2012 (MARKETWIRE via COMTEX) -- Quidel Corporation (NASDAQ: QDEL), announced today that it received CE mark for the AmpliVue C. difficile assay, its non-instrumented molecular test for the detection of toxigenic Clostridium difficile bacterial DNA. Detection of the pathogen is achieved using a hand-held fully contained detection cassette which utilizes lateral flow technology. C. difficile is frequently associated with antibiotic therapy and often causes diarrhea and inflammation of the colon.
"Clostridium difficile infections can be life-threatening and are therefore critically important to diagnose as soon as possible. Molecular testing offers greater sensitivity and faster turn-around-times compared to many other methods," according to Dr. Timothy Stenzel, M.D., Ph.D., chief scientific officer of Quidel.
A recent study published in the Lancet(1) suggests that a majority of the hospital-based labs in Europe continue to use traditional methods such as immunoassays or cytotoxicity assays. These assays may either lack sufficient sensitivity or are difficult to perform and may require several days to yield results. The AmpliVue C. difficile assay will allow these labs to quickly implement a fast and sensitive molecular method without the purchase of expensive capital equipment.
"We are delighted to receive CE mark for our AmpliVue C. difficile assay," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "The AmpliVue C. difficile assay will allow those labs that have previously opted for traditional methods to offer a more sensitive molecular test for patients in their care."
The C. difficile assay is Quidel's first assay in the hand-held AmpliVue format, and is currently 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.
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(R), D3(R) Direct Detection and Thyretain(TM) leading brand names, as well as under the new Sofia(R) and Quidel Molecular(TM) brands, Quidel's products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, including 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 www.quidel.com and Diagnostic Hybrids at www.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.
(1) Clostridium difficile infection in Europe: a hospital-based survey, Lancet 2011; 377: 63-73.
Chief Financial Officer
Media and Investors Contact: