Quidel Receives FDA Clearance for Its Sofia(R) RSV Fluorescent Immunoassay (FIA)
(Marketwire Via Acquire Media NewsEdge) SAN DIEGO, CA -- (Marketwired) -- 08/19/13 --
Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Sofia RSV FIA test for use with the Sofia Analyzer for the rapid, objective detection of respiratory syncytial virus (RSV) infections.
RSV is responsible for respiratory tract infections, principally among pediatric and elderly populations. In the pediatric setting, nearly half of all children become infected by RSV in their first year of life. In the United States, RSV is estimated to be responsible for 73,400 to 126,300 hospitalizations annually for bronchiolitis and pneumonia among children younger than one year.(1)
Sofia is the brand name for Quidel's next-generation, immunoassay system. The Sofia Analyzer and Sofia RSV FIA employ unique immunofluorescence chemistry, advanced lateral flow technology, and failure alert and fail-safe systems designed to ensure a reliable, objective, highly accurate, diagnostic result within fifteen (15) minutes of application of the patient's specimen.
"We are pleased to receive FDA clearance for the Sofia RSV FIA, our fourth Sofia FIA product and the third to receive FDA clearance since June this year," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "With its rapidly expanding menu, our Sofia System now offers a comprehensive menu of accurate and easy-to-use assays for the diagnosis of key respiratory diseases and pregnancy. These accomplishments provide healthcare workers with yet another compelling reason to adopt the Sofia system."
The 510(k) clearance allows Quidel to market and sell its new Sofia RSV FIA in the United States. The Sofia Analyzer was 510(k) cleared in October of 2011 and CLIA-waived in April 2012. In addition to the RSV FIA, Sofia now enables rapid immunofluorescence assays for three other FDA-cleared FIAs: Influenza A+B, Strep A and hCG for pregnancy.
(1) Collins P., Chanock R., Murphy B. Fields Virology. Fourth Edition. Volume 1.Chapter 45 -Respiratory Syncytial Virus. Lippincot Williams and Wilkins (2001).
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.
Chief Financial Officer
Media and Investors Contact:
[ InfoTech Spotlight's Homepage ]