Diagnostic Hybrids Receives Approval From Chinese SFDA For D3(R) Ultra™ DFA Respiratory Virus Screening And ID Kit

Main Category: Respiratory / Asthma
Also Included In: Regulatory Affairs / Drug Approvals;  Infectious Diseases / Bacteria / Viruses
Article Date: 07 Jul 2010 - 1:00 PDT

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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.

Source:
Quidel Corporation

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