Quidel Corporation (NASDAQ: QDEL) (Quidel), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received CE Mark to market Quidels Sofia 2 Lyme+ FIA to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi, Borrelia garinii, and Borrelia afzelii from serum and plasma specimens. The test is specifically developed for the European market and intended for use with the Sofia 2 analyzer to aid in the diagnosis of Lyme disease.
Sofia 2 is Quidels next-generation version of its best-selling Sofia instrumented system. Sofia 2 utilizes the original Sofias fluorescent chemistry design while improving upon the graphical user interface and optics system to provide an accurate, automated and objective result in as few as 3 minutes. Sofia 2 also integrates ethernet connectivity and its barcode scanner within a smaller footprint than the legacy Sofia instrument.
Lyme disease (LD) is the most common tickborne disease in North America and Europe.1 While Lyme disease is caused by the Borrelia burgdorferi bacterium in the U.S., Borrelia afzelii and Borrelia garinii are the major pathogenic species found in Europe, transmitted through the bite of an infected tick.1,2 Patients infected with B. burgdorferi, B. afzelii, and/or B. garinii may experience symptoms associated with three stages: early localized disease, early disseminated disease, and late persistent disease.1 The most characteristic symptom of early localized disease is the appearance of erythema migrants (EM) on the skin, which appears in up to 80% of cases.1,4 EM may also be accompanied by flu-like symptoms (headache, abdominal pain, and fatigue) days or weeks after infection.4 In the second stage, early disseminated disease, untreated patients may begin to see neurological and rheumatological manifestations, and less commonly, dermatological, cardiac, or ophthalmological manifestations. These symptoms generally appear weeks to months after infection.1 If the disease continues to be left untreated, late persistent disease may also follow months or years later.4 In late stage disease, patients may see continued progression of manifestations in the joints, heart, skin, and nervous system.2
Early detection and treatment of LD can help resolve symptoms and prevent progression of the disease.1 The primary means of identifying B. burgdorferi, B. afzelii, and B. garinii infection is detection of the bodys IgM and IgG antibody response using immunoassay. Detection of IgM antibodies to B. burgdorferi, B. afzelii, and B. garinii is generally most significant in the earlier stages of the disease. Conversely, detection of IgG antibodies has proven to be significant for longer periods, as the antibodies may remain detectable years after infection.4
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With the addition of the antigens specific to the predominant Borrelia strains in Europe, the Sofia 2 Lyme+ assays CE mark for use on the Sofia 2 instrument will allow healthcare workers to generate an accurate, faster result, thereby accelerating the diagnosis and potential treatment of Lyme Disease for the patient. This is another example of our ability to provide simple, cost-effective solutions for physician offices and hospitals that previously had to wait several days for send-out Lyme results, said Douglas Bryant, president and chief executive officer of Quidel Corporation. We expect that this new product introduction will increase the value and utilization of our Sofia 2 platform in Europe and could create incremental instrument placement opportunities in the near to medium term.
Quidel also markets other Sofia immunoassays in the EU to aid in the diagnosis of infections such as Influenza A+B, Respiratory Syncytial Virus (RSV), Group A Streptococcus, Legionella, and S. pneumoniae.
- Wormser, G. P., Dattwyler, R. J., Shapiro, E. D., Halperin, J. J., Steere, A. C., Klempner, M. S., Nadelman, R. B. (2006). The Clinical Assessment, Treatment, and Prevention of Lyme Disease, Human Granulocytic Anaplasmosis, and Babesiosis: Clinical Practice Guidelines by the Infectious Diseases Society of America. Clinical Infectious Diseases, 43(9), 1089-1134.
- Stanek, G., Strle, F. (2008). Lyme Disease “ European Perspective. Infectious Disease Clinics of North America, 22(2), 327-339.
- Aguero-Rosenfeld, M. E., Wang, G., Schwartz, I., & Wormser, G. P. (2005). Diagnosis of Lyme Borreliosis. Clinical Microbiology Reviews, 18(3), 484-509.
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 Sofia, QuickVue, D3 Direct Detection, Thyretain, Triage and InflammaDry leading brand names, as well as under the new Solana, AmpliVue and Lyra molecular diagnostic brands, Quidels 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 recently acquired Triage system of tests comprises a comprehensive test menu that provides rapid, cost-effective treatment decisions at the point-of-care (POC), offering a diverse immunoassay menu in a variety of tests to provide diagnostic answers for quantitative BNP, CK-MB, d-dimer, myoglobin, troponin I and qualitative TOX Drug Screen. Quidels research and development engine is also developing a continuum of diagnostic solutions from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare in physicians offices and hospital and reference laboratories. For more information about Quidels comprehensive product portfolio, visit quidel.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, a final determination that some of the provisions of our contractual arrangement with Beckman Coulter are unenforceable or otherwise not valid; our reliance on sales of our influenza diagnostic tests; fluctuations in our operating results resulting from the timing of the onset, length and severity of cold and flu seasons, seasonality, 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, lower than anticipated market penetration of our products, the quantity of our product in our distributors inventory or distribution channels, changes in the buying patterns of our distributors, and changes in the healthcare market and consolidation of our customer base; our development and protection of proprietary technology rights; our development of new technologies, products and markets; our reliance on a limited number of key distributors; intellectual property risks, including but not limited to, infringement litigation; our need for additional funds to finance our capital or operating needs; the financial soundness of our customers and suppliers; acceptance of our products among physicians and other healthcare providers; competition with other providers of diagnostic products; adverse actions or delays in new product reviews or related to currently-marketed products by the U.S. Food and Drug Administration (the FDA) or other regulatory authorities or loss of any previously received regulatory approvals or clearances; changes in government policies; our exposure to claims and litigation, including litigation currently pending against us; costs of or our failure to comply with government regulations in addition to FDA regulations; compliance with government regulations relating to the handling, storage and disposal of hazardous substances; third-party reimbursement policies; our failure to comply with laws and regulations relating to billing and payment for healthcare services; our ability to meet demand for our products; interruptions in our supply of raw materials; product defects; business risks not covered by insurance; our exposure to cyber-based attacks and security breaches; competition for and loss of management and key personnel; international risks, including but not limited to, compliance with product registration requirements, exposure to currency exchange fluctuations and foreign currency exchange risk sharing arrangements, 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 U.S. markets; changes in tax rates and exposure to additional tax liabilities or assessments; risks relating to the acquisition and integration of the Triage and BNP Businesses; Aleres failure to perform under various transition agreements relating to our acquisition of the Triage and BNP Businesses; that we may incur substantial costs to build our information technology infrastructure to transition the Triage and BNP Businesses; that we may have to write off goodwill relating to our acquisition of the Triage and BNP Businesses; that we our ability to manage our growth strategy; the level of our indebtedness; the amount of, and our ability to repay, renew or extend, our outstanding debt and its impact on our operations and our ability to obtain financing; that substantially the Senior Credit Facility is secured by substantially all of our assets; our prepayment requirements under the Senior Credit Facility; the agreements for our indebtedness place operating and financial restrictions on the Company; that an event of default could trigger acceleration of our outstanding indebtedness; our inability to settle conversions of our Convertible Senior Notes in cash; the effect on our operating results from the trigger of the conditional conversion feature of our Convertible Senior Notes; that we may incur additional indebtedness; increases in interest rate relating to our variable rate debt; dilution resulting from future sales of our equity; volatility in our stock price; provisions in our charter documents, Delaware law and the indenture governing our Convertible Senior Notes that might delay or impede stockholder actions with respect to business combinations or similar transactions; and our intention of not paying dividends. Forward-looking statements typically are identified by the use of terms such as may, will, should, might, expect, anticipate, estimate, plan, intend, goal, project, strategy, future, and similar words, although some forward-looking statements are expressed differently. The risks described in reports and registration statements that we file with the Securities and Exchange Commission (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 managements analysis only as of the date of this press release. Except as required by law, we undertake no obligation to publicly release the results of any revision or update of these forward-looking statements, whether as a result of new information, future events or otherwise.
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