SHANGHAI, China -- (BUSINESS WIRE) --
Diagnostic Hybrids Inc. (DHI), a Quidel Company (NASDAQ:QDEL), received permission from the People's Republic of China's State Food and Drug Administration (SFDA) to register its D3® UltraTM DFA Respiratory Virus Screening and ID Kit on the Chinese market. The D3 Ultra DFA Respiratory Virus Screening and ID Kit is a direct fluorescence assay (DFA) that provides rapid, sensitive and specific screening and identification of Influenza A, Influenza B, Respiratory Syncytial Virus, Adenovirus, and Parainfluenza 1, 2, and 3. Results from direct testing of patient specimens are obtained as quickly as 15 minutes, or alternatively within 24-48 hours upon reflexing the specimen into proprietary cell culture using either the patented R-MixTM or R-Mix TooTM Mixed FreshFrozenTM cell culture system. According to DHI's distributor, Shanghai B&C, D3 Ultra DFA Respiratory Virus Screening and ID Kit belongs to "Class III" which is the highest level of medical device in China.
The availability of this product is considered of great help to the respiratory physician. "The detection of respiratory virus antigens with a fluorescence assay provides an additional, useful tool in the diagnosis of respiratory infection" said Dr. Quan Lu, vice director of the Subspecialty Group of Respiratory Diseases, The Society of Pediatrics, Chinese Medical Association. "The application of the technique may help to control antibiotic abuse and to effectively monitor pediatric respiratory infections."
DHI and Shanghai B&C performed intensive evaluation and clinical research on the D3 Ultra DFA Respiratory Virus Screening and ID Kit in China. The product has obtained praise and approval from many influential hospitals and institutes including Capital Institute of Pediatrics, Shanghai Children's Hospital, Children's Hospital of Fudan University and Guangzhou Institute of Respiratory Diseases.
"This clearance marks an important milestone in our working relationship with Shanghai B&C and our first step in bringing our continuum of diagnostic products to China," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "The D3 Ultra DFA Respiratory Virus Screening and ID Kit is an established market leader in the United States clinical virology testing market. With the significant local management support of Shanghai B&C and this approval to commercialize the kit in China, we expect similar longer-term success in a market that has the potential to be as large as the U.S. respiratory virus testing segment."
"This is important news for healthcare professionals in China, especially those stationed in Children's and large Tier III-level hospitals, and CDC laboratories" stated David Scholl, Ph.D., senior vice president, commercial operations and president of DHI. "Molecular-based equipment and reagent costs can be prohibitive as well as the need for sophisticated technical expertise to perform molecular tests. D3 Ultra will give labs in China a cost-effective alternative for detecting multiple respiratory viruses, including influenza viruses, that is simple to do, fast, reliable and accurate."
Quidel and DHI will showcase the D3 Ultra products to physicians and healthcare providers from China and the international medical community in the Options for the Control of Influenza VII international conference which takes place in Hong Kong SAR, China on September 3-7, 2010. Quidel's full array of respiratory virus rapid tests and cell culture and DFA confirmation portfolio will also be presented.
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 leading brand names QuickVue®, D3® Direct Detection and ThyretainTM, 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.
About Shanghai B&C
Shanghai B&C is committed to providing high quality diagnostic solutions for hospitals and clinical labs in China. The products marketed by Shanghai B&C aim to aid in the diagnosis of many critical diseases especially infectious diseases, cardiovascular diseases and hepatic fibrosis. To ensure the products meet physicians' expectation and legal requirements, Shanghai B&C has established a professional team to perform evaluation, clinical research and registration on them before marketing. The approved products are promoted and marketed by Shanghai B&C through its well-organized distribution network covering mainland China.
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.
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