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September 18, 2009 at 7:31 PM EDT

Quidel Issues Clarification Regarding Special 510(k) Clearance to Add 2009 H1N1 Influenza A Virus Reactivity Information to the QuickVue Influenza A+B Test Package Insert

SAN DIEGO--(BUSINESS WIRE)--Sep. 18, 2009-- Quidel Corporation (NASDAQ: QDEL), a global leader in point-of-care (POC) rapid diagnostic tests, issues clarification regarding the Special 510(k) clearance for an update to the Company's QuickVue® Influenza A+B test package insert. A news wire agency released misleading information stating there is a new swine flu version of Quidel’s QuickVue Influenza A+B test and that FDA approved this new version. This statement is incorrect.

Quidel did obtain Special 510(k) clearance for an update to the QuickVue Influenza A+B test package insert to include reactivity with culture isolates of the 2009 H1N1 Influenza A virus. Although the QuickVue Influenza A+B test has been shown to detect the 2009 influenza A (H1N1) virus, the performance characteristics of this device with clinical specimens that are positive for the 2009 influenza A (H1N1) virus have not been established. The QuickVue Influenza A+B test kit can distinguish between influenza A and B viruses, but it cannot differentiate influenza subtypes.

Douglas Bryant, president and chief executive officer, clarified, “The Special 510(k) clearance was for an update to the package insert. The QuickVue Influenza A+B test can detect cultured isolates of the 2009 influenza A (H1N1) virus, however, the clinical performance with actual clinical specimens has not been demonstrated.”

About Quidel Corporation

Quidel Corporation serves to enhance the health and well being of people around the globe through the discovery, development, manufacturing and marketing of rapid diagnostic solutions at the point of care (POC) in infectious diseases and reproductive health. Marketed under the leading brand name of QuickVue®, Quidel’s portfolio of products currently includes tests that aid in the diagnosis of several disease or condition states, including influenza, respiratory syncytial virus, Fecal Occult Blood, Strep A, pregnancy, bacterial vaginosis, H. pylori and Chlamydia. Quidel's products are sold to healthcare professionals with a focus on the physician office lab and acute care markets through leading medical distribution partners on a worldwide basis. Quidel'sSpecialty Products Group (SPG) develops research products in the fields of oncology and bone health with potential future point-of-care applications. By building value in rapid diagnostic tests, Quidel provides leadership to the industry and among healthcare professionals allowing for the movement of patient testing out of the central laboratory setting and into the physician office, urgent care and other outpatient settings where rapid testing and treatment has an impact on clinical outcomes and provides an economic benefit. For more information, visit www.flutest.com, www.quidel.com, and www.colorectal-test.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. 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, 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. 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.

Source: Quidel Corporation

Quidel Investor Relations Contact :
John M. Radak, Chief Financial Officer, 858-646-8032
Quidel Public Relations Contact:
Debora Demarest, 858-552-1100, x 1208
Media Contact:
Burns McClellan
Justin Jackson, 212-213-0006