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Diagnostic Hybrids, Inc. Receives FDA Emergency Use Authorization for D3 Ultra 2009 H1N1 Influenza A Virus ID Kit


2/24/2010 7:04:43 AM

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SAN DIEGO--(BUSINESS WIRE)--Diagnostic Hybrids, a Quidel Company has received emergency use authorization from the U.S. Food and Drug Administration (FDA) for its D3® UltraTM 2009 H1N1 Influenza A Virus ID Kit, a monoclonal antibody fluorescent staining kit for the specific identification of 2009 H1N1 influenza A in direct patient specimens or incubated tissue cultures. The D3 Ultra 2009 H1N1 Influenza A Virus ID Kit is to be used for individuals with signs and symptoms of influenza and who previously tested positive for the presence of influenza A virus-infected cells by a currently available FDA-cleared direct immunofluorescence influenza A antibody device such as the D3 Ultra Respiratory Virus Screening and ID Kit. Emergency use authorization allows for the early availability of important diagnostic and therapeutic tools “to diagnose, treat, or prevent serious or life-threatening diseases or conditions […] when there are no adequate, approved and available alternatives.”1

“During the ongoing influenza surveillance, it is important for us to provide laboratories with the best possible influenza testing solutions,” said Steve Ewers, senior product manager at Diagnostic Hybrids. “Currently available tests are all based on the detection of 2009 H1N1 nucleic acid. This technology is not available in all laboratories due to its equipment expense and complexity. The D3 Ultra 2009 H1N1 ID Kit gives these laboratories the opportunity to identify 2009 H1N1 influenza A virus using the immunofluorescent methodologies without any added equipment or training.”

“The FDA’s emergency use authorization of Diagnostic Hybrids’ H1N1 Influenza A Virus ID kit will allow access to a monoclonal antibody product with great potential for expediting patient care in a time when fast, accurate diagnosis of 2009 H1N1 infection is critical,” said David R. Scholl, Ph.D., senior vice president, commercial operations & president of Diagnostic Hybrids. “As we enter the main part of flu season in North America, we are proud to provide large and small laboratories alike with a cost-effective method for the detection of 2009 H1N1 infections.”

The D3 Ultra H1N1 ID Kit is the first indirect fluorescent assay available on the market that specifically identifies the 2009 H1N1 influenza A virus from nasopharyngeal swabs, aspirates and washes. It complements the company’s other respiratory testing technologies, which can detect the H1N1 virus as influenza A positive, but do not specifically identify the 2009 H1N1 influenza virus subtype.

About Quidel Corporation

Quidel Corporation serves to enhance the health and well being of people around the globe through the development of rapid diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to healthcare providers. Marketed under the leading brand names QuickVue®, D3 Direct Detection™ and Thyretain™, Quidel’s products aid in the detection and diagnosis of many critical diseases and conditions, including influenza, respiratory syncytial virus, Strep A, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel’s research and development engine, including its Specialty Products Group, 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 our strategic initiatives, uncertainty surrounding the detection of novel influenza viruses involving human specimens, adverse changes in the competitive and economic conditions in domestic and international markets, actions of our major distributors, technological changes and uncertainty with research and technology development, including any future molecular-based technology, the 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, intellectual property, product liability, environmental or other litigation, potential required patent license fee payments not currently reflected in our costs, potential inadequacy of booked reserves and possible impairment of goodwill, and lower-than-anticipated sales or market penetration of our new products. Further, with respect to the acquisition of Diagnostic Hybrids, Inc. and related statements, these statements are based on our current expectations as to future events, but are subject to numerous risks and uncertainties. These risks and uncertainties include the potential that Diagnostic Hybrids’ growth will not follow historical patterns and the possibility that integration of the two companies will not be as successful as we expect. Quidel can give no assurance that future results will be as expected. 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 Emergency Use Authorization of Medical Products, U.S. Food & Drug Administration, http://www.fda.gov/RegulatoryInformation/Guidances/ucm125127.htm

Contact:

Quidel Corporation John M. Radak, Chief Financial Officer 858-646-8032 or Media and Investors Contact: Porter Novelli Life Sciences Pam Lord, 619-849-6003 plord@pnlifesciences.com


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