Diagnostic Hybrids, Inc. Receives Approval from Chinese SFDA for D3(R) Ultra(TM) DFA Respiratory Virus Screening and ID Kit
Published: Jul 01, 2010
SAN DIEGO--(BUSINESS WIRE)--Diagnostic Hybrids, a Quidel Company (NASDAQ:QDEL), received approval from the People’s Republic of China’s State Food and Drug Administration (SFDA) for its D3 Ultra DFA Respiratory Virus Screening and ID Kit. 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, Parainfluenza 1, 2, & 3, Respiratory Syncytial Virus and Adenovirus. "This clearance marks an important milestone in our international expansion strategy," 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 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,” stated David Scholl, Ph.D., senior vice president, commercial operations and president of Diagnostic Hybrids. “Many laboratories in emerging markets find that molecular-based equipment and reagent costs are prohibitive. D3 Ultra will give labs in China a cost-effective alternative for detecting multiple respiratory viruses that is fast, reliable and accurate.” The D3 Ultra DFA Respiratory Virus Screening and ID Kit can be used in direct testing of patient specimens with results in as fast as 15 minutes, or in cell culture with the patented R-MixTM and R-Mix TooTM Mixed FreshCellsTM cell culture systems within 24-48 hours. 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(R), D3(R) Direct Detection and Thyretain(TM), 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.