Quidel Corporation Receives CLIA Waiver for Its Sofia(TM) Analyzer and Sofia Influenza A+B Fluorescent Immunoassay (FIA)
Published: Apr 23, 2012
SAN DIEGO, CA--(Marketwire - April 20, 2012) - Quidel Corporation (NASDAQ: QDEL), a leading provider of rapid diagnostic testing solutions and cell-based virology assays, announced today that it has received Clinical Laboratory Improvement Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA) for the Quidel Sofia™ Analyzer and the Sofia Influenza A+B Fluorescent Immunoassay (FIA) for the rapid, differential detection of Influenza types A and B in nasal swab and nasopharyngeal swab specimens.
The simple-to-use Sofia Analyzer and Sofia Influenza A+B FIA employ unique software and immunofluorescence-based chemistry to yield an automated, objective and highly reliable result for aiding in the diagnosis of influenza within minutes of obtaining the swab specimen from the patient. In addition to the several thousand hospitals, medical centers and smaller clinics in the United States, the receipt of CLIA waiver markedly expands the available market for the Sofia test system.
"We are very pleased to receive CLIA waiver for our Sofia system because this permits us to sell to the CLIA waived physician office labs, emergency departments, and other CLIA waived facilities," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "We are very proud of this achievement, and we are excited about the ability to provide physicians in any medical setting with highly accurate diagnostic solutions within minutes of the arrival of their patient."
The Sofia test system is CE-marked, 510(k) cleared, and commercially available in Europe, the United States and the rest of the world.
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 Quidel Molecular™ 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 molecular-based technology, the medical 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 (the "FDA"), our ability to comply with FDA, environmental and other regulations, our ability to meet unexpected increases in demand for our products, our ability to execute our 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 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.
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