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510(k) Clearance Added to Quidel Corporation (QDEL)'s Package Inserts for 3 Influenza Tests



7/16/2013 6:52:51 AM

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Quidel Obtains Special 510(k) Clearance to Add Avian Influenza A (H7N9) Virus Analytical Reactivity Information to the Package Inserts for All Three of Its Rapid Diagnostic Tests for Influenza

SAN DIEGO, CA--(Marketwired - July 15, 2013) -

Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic testing solutions, cell-based virology assays and molecular diagnostic systems, received Special 510(k) clearance for an update to the Company's immunofluorescence-based Sofia® Influenza A+B FIA package insert to include analytical reactivity with an avian Influenza A (H7N9) strain, A/Anhui/1/2013, on July 5th, 2013. Clearances of additional Special 510(k)s for its QuickVue® Influenza A+B and QuickVue Influenza visually read tests were also granted (June 28th and July 5th, respectively). The package inserts for all three products are being updated accordingly.

The novel influenza A (H7N9) virus is an avian influenza virus that has been shown to infect people in close contact with infected birds. In China, according to the CDC, approximately 130 people are known to have been infected with this virus and as of May 30, thirty-six (36) have died.(1) This virus is an avian influenza virus and is not readily human-to-human transmissible, but it is a high risk virus with pandemic potential. So far, no human cases have been identified outside of China.

The Sofia Influenza A+B FIA and both QuickVue influenza tests have been shown to detect the cultured A/Anhui/1/2013 virus analytically. However, the performance characteristics of these devices with clinical specimens from people that are positive for the A/Anhui/1/2013-like influenza A (H7N9) infection have not been established. The Sofia Influenza A+B FIA and the two QuickVue influenza kits can detect influenza A viruses, including this novel avian virus, but they cannot differentiate influenza A subtypes -- i.e., they cannot specifically identify this novel avian A (H7N9) or other avian or human influenza A subtypes.

Douglas Bryant, Quidel's president and chief executive officer, commented, "The first human infection with the novel avian influenza A (H7N9) was reported in China on April 1, 2013 -- only three and one half months ago.(1) The ability of the WHO, our U.S. regulatory and public health agencies, and our industry to react so quickly to dangerous, emergent viruses is an essential element of public health in the future, especially given the rapidly growing population and profound interconnectivity of the world's people made possible by rapid, comparatively inexpensive travel and commerce. Rapid tests, when used appropriately and correctly," Mr. Bryant added, "are useful tools in the effort to help diminish the spread of influenza. Quidel will continue to be alert to the advent of emergent influenza viruses with the intention of being poised to respond to important public health initiatives."

(1) http://www.cdc.gov/flu/avianflu/h7n9-virus.htm, as of July 12, 2013.

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, fluctuations in our operating results resulting from seasonality; the timing of the onset, length and severity of cold and flu seasons; government and media attention focused on influenza and the related potential impact on humans from novel influenza viruses; adverse changes in competitive conditions in domestic and international markets; the reimbursement system currently in place and future changes to that system; changes in economic conditions in our domestic and international markets; changes in sales levels as it relates to the absorption of our fixed costs; lower than anticipated market penetration of our products; the quantity of our product in our distributors' inventory or distribution channels and changes in the buying patterns of our distributors; our development of new technologies, products and markets; our development and protection of intellectual property; our reliance on a limited number of key distributors; our reliance on sales of our influenza diagnostics tests; our ability to manage our growth strategy, including our ability to integrate companies or technologies we have acquired or may acquire; intellectual property risks, including but not limited to, infringement litigation; limitations and covenants in our senior credit facility; that we may incur significant additional indebtedness; our need for additional funds to finance our operating needs; volatility and disruption in the global capital and credit markets; acceptance of our products among physicians and other healthcare providers; competition with other providers of POC diagnostic products; changes in government policies; adverse actions or delays in product reviews by the U.S. Food and Drug Administration (the "FDA"); compliance with other government regulations, such as safe working conditions, manufacturing practices, environmental protection, fire hazard and disposal of hazardous substances; third-party reimbursement policies; our ability to meet demand for our products; interruptions in our supply of raw materials; product defects; business risks not covered by insurance; the loss of key personnel; international risks, including but not limited to, compliance with product registration requirements, exposure to currency exchange fluctuations, longer payment cycles, lower selling prices and greater difficulty in collecting accounts receivable, reduced protection of intellectual property rights, political and economic instability, taxes, and diversion of lower priced international products into US markets; our failure to maintain adequate internal control over financial reporting; volatility in our stock price; dilution resulting from future sales of our equity; and provisions in our charter documents and Delaware law that might delay stockholder actions with respect to business combinations or the election of directors. 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.


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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