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Quidel Corporation (QDEL) Receives CE Mark for Its Direct Specimen Rapid PCR Test for Toxigenic Clostridium Difficile


4/3/2012 6:51:42 AM

SAN DIEGO, CA--(Marketwire - April 02, 2012) -

Quidel Corporation (NASDAQ: QDEL) 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(i) 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.

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 Quidel Molecular™ 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.

(i) Vital Signs: Preventing Clostridium difficile Infections Weekly March 9, 2012 / 61(09);157-162 Morbidity and Mortality Weekly Report (MMWR)


Quidel Contact:
Quidel Corporation
Randy Steward
Chief Financial Officer
(858) 552-7931

Media and Investors Contact:
Quidel Corporation
Ruben Argueta
(858) 646-8023
Email Contact


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