SAN DIEGO--(BUSINESS WIRE)--Quidel Corporation, a global leader in point-of-care (POC) rapid diagnostic tests, received Special 510(k) clearance for an update to the Company’s 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.
This clearance supplements the reactivity with 13 other isolates of seasonal H1N1 influenza viruses currently listed in the package insert. In total, 34 different isolates of human Influenza A, 13 different isolates of human Influenza B, and 24 different isolates from birds and mammals have now been shown to be detectable by the QuickVue Influenza A+B test.
Douglas Bryant, president and chief executive officer, stated, “Rapid tests, when used appropriately and correctly, are useful tools in the effort to help diminish the spread of influenza. In one visit, with just one nasal swab, Quidel’s test can provide a result in approximately 10 minutes, aiding the selection and initiation of the appropriate treatment modality.”
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’s Specialty 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.
Contact:
Quidel Investor Relations: John M. Radak, Chief Financial Officer, 858-646-8032 or Quidel Public Relations: Debora Demarest, 858-552-1100 x1208 or Media: Burns McClellan Justin Jackson, 212-213-0006 jjackson@burnsmc.com
