SAN DIEGO--()--Quidel Corporation (NASDAQ: QDEL), a leading provider of rapid diagnostic testing solutions, announced today that it has begun taking orders for its QuickVue®+ lateral flow diagnostic test for infectious mononucleosis. Due to strong customer demand, the Company has restarted manufacturing its previous mononucleosis product with shipments to customers expected during the first week of August.
“Our end users have expressed a strong desire for us to bring back our IgM-specific QuickVue+ Infectious Mononucleosis test. This test will strengthen our existing QuickVue respiratory franchise, while leveraging our QuickVue manufacturing efficiencies.”
“Our end users have expressed a strong desire for us to bring back our IgM-specific QuickVue+ Infectious Mononucleosis test. This test will strengthen our existing QuickVue respiratory franchise, while leveraging our QuickVue manufacturing efficiencies.” said Douglas Bryant, president and chief executive officer of Quidel Corporation.
This 5-minute test continues to deliver IgM specificity in a unique plus/minus format with high clinical sensitivity and specificity.
Infectious mononucleosis (“Mono” or IM), is an infectious, widespread viral disease caused by the Epstein-Barr virus (EBV), a type of herpes virus to which more than 95% of adults have been exposed worldwide.[1,2] The infection is spread primarily by saliva, and is more prevalent in adolescents and young adults age 10-30.[2,3] Infection by the Epstein-Barr Virus leads to infectious mononucleosis 35-50% of the time. During the initial 4-6 week incubation period, the patient can present with the classical symptoms such as fever, sore throat, and swollen lymph glands. Accordingly, it is important to assist in the diagnosis of Mono through objective testing, like the QuickVue+ Infectious Mononucleosis test provides.
1 CDC: Epstein-Barr Virus; Disease Information: http://www.cdc.gov/ncidod/diseases/ebv.htm
2 Infectious Mononucleosis: Katherine Luzuriaga, M.D., and John L. Sullivan, M.D., N. Eng J. Med 362; 21; 2010
3 Epstein-Barr Virus Infectious Mononucleosis: Mark Ebell, M.D., M.S Am Fam Physician. 2004 Oct 1:70 (7):1279-1287: http://www.aafp.org/afp/2004/1001/p1279.html
About Quidel Corporation
Quidel Corporation serves to enhance the health and well being of people around the globe through the development of rapid diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the leading brand names QuickVue®, D3® Direct Detection and Thyretain™, Quidel's products aid in the detection and diagnosis of many critical diseases and conditions, including 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 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, successful integration of Diagnostic Hybrids Inc., 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, potential 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.