FDA grants Diagnostic Hybrids emergency use authorization for 2009 H1N1 Influenza A Virus ID Kit

Quidel CorporationFeb 23 2010

Diagnostic Hybrids, a Quidel Company (NASDAQ: QDEL) has received emergency use authorization from the U.S. Food and Drug Administration (FDA) for its D^3® Ultra^TM 2009 H1N1 Influenza A Virus ID Kit, a monoclonal antibody fluorescent staining kit for the specific identification of 2009 H1N1 influenza A in direct patient specimens or incubated tissue cultures. The D³ Ultra 2009 H1N1 Influenza A Virus ID Kit is to be used for individuals with signs and symptoms of influenza and who previously tested positive for the presence of influenza A virus-infected cells by a currently available FDA-cleared direct immunofluorescence influenza A antibody device such as the D³ Ultra Respiratory Virus Screening and ID Kit. Emergency use authorization allows for the early availability of important diagnostic and therapeutic tools “to diagnose, treat, or prevent serious or life-threatening diseases or conditions […] when there are no adequate, approved and available alternatives.”

“As we enter the main part of flu season in North America, we are proud to provide large and small laboratories alike with a cost-effective method for the detection of 2009 H1N1 infections.”

“During the ongoing influenza surveillance, it is important for us to provide laboratories with the best possible influenza testing solutions,” said Steve Ewers, senior product manager at Diagnostic Hybrids. “Currently available tests are all based on the detection of 2009 H1N1 nucleic acid. This technology is not available in all laboratories due to its equipment expense and complexity. The D³ Ultra 2009 H1N1 ID Kit gives these laboratories the opportunity to identify 2009 H1N1 influenza A virus using the immunofluorescent methodologies without any added equipment or training.”

“The FDA’s emergency use authorization of Diagnostic Hybrids’ H1N1 Influenza A Virus ID kit will allow access to a monoclonal antibody product with great potential for expediting patient care in a time when fast, accurate diagnosis of 2009 H1N1 infection is critical,” said David R. Scholl, Ph.D., senior vice president, commercial operations & president of Diagnostic Hybrids. “As we enter the main part of flu season in North America, we are proud to provide large and small laboratories alike with a cost-effective method for the detection of 2009 H1N1 infections.”

The D³ Ultra H1N1 ID Kit is the first indirect fluorescent assay available on the market that specifically identifies the 2009 H1N1 influenza A virus from nasopharyngeal swabs, aspirates and washes. It complements the company’s other respiratory testing technologies, which can detect the H1N1 virus as influenza A positive, but do not specifically identify the 2009 H1N1 influenza virus subtype.