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Quidel Corporation (QDEL) Receives CE Mark for Its Molecular Diagnostic Test


3/26/2013 6:40:01 AM

SAN DIEGO, CA--(Marketwire - March 25, 2013) - Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic testing solutions, cell-based virology assays and molecular diagnostic solutions, announced today that it received the CE Mark for its Quidel Molecular Direct HSV 1+2/VZV assay for the differentiation and detection of herpes simplex viruses 1 and 2 (HSV 1+2) and varicella-zoster virus (VZV) in active lesions.

Quidel's new PCR assay kit distinguishes between three infectious diseases: HSV 1, the virus responsible for most cold sores and some genital herpes transmissions; HSV 2, the virus primarily responsible for most genital herpes and some cold sores; and VZV, the virus responsible for chicken-pox in children and shingles among adults.

"The Centers for Disease Control and Prevention (CDC) estimates that there are almost 800,000 new cases of herpes in the United States each year, and about 1 in 6 Americans aged 14 to 49 have a genital HSV 2 infection,"(1) said Dr. Timothy Stenzel, M.D., Ph.D., chief scientific officer of Quidel. "Although the classical signs of herpes are easy enough to recognize, the majority of patients present with atypical lesions that can be misinterpreted or confused among these three or other infections. For this reason, the introduction of a fast and accurate molecular test that distinguishes between HSV 1, HSV 2 and VZV is not only desirable, but is also consistent with recently issued European guidelines on managing genital herpes."(2)

The Quidel Molecular Direct HSV 1+2/VZV 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 instead of freezing, ready-to-use reagents, a short time to result, and other benefits that favorably affect diagnostic test outcome.

The Quidel Molecular Direct HSV 1+2/VZV assay kit includes an extraction-free, three-step sample preparation process that requires no heat step, no timed step, and no centrifugation as added benefits. This fast and easy direct-to-amplification procedure allows the assay to generate a result in under an hour.

"We are pleased to receive the CE Mark for our fifth Quidel Molecular assay," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "Our Quidel Molecular Direct HSV 1+2/VZV assay allows us to offer a molecular complement to our best-selling ELVIS cell-based assay for herpes detection. Hospital workers will now have the ability to quickly diagnose similar herpes diseases in children and adults through the characterization of samples obtained from lesions."

Quidel offers other CE Marked and 510(k)-cleared molecular tests in the Real-Time PCR format for Influenza A+B, hMPV, RSV + hMPV and C. difficile.

1. http://www.cdc.gov/std/Herpes/STDFact-Herpes.htm

2. http://www.iusti.org/regions/europe/pdf/2010/Euro_Guideline_2010_herpes.pdf

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 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 future molecular-based technology, the medical reimbursement system currently in place and future changes to that system, manufacturing and production delays or difficulties, adverse regulatory actions or delays in product reviews by the U.S. Food and Drug Administration (the "FDA"), compliance with FDA and environmental regulations, our ability to meet unexpected increases in demand for our products, our ability to execute our growth 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 Securities and Exchange Commission (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.

0722ID0313I (03/13)


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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