Quidel Corporation (NASDAQ: QDEL), a leading provider of rapid point-of-care diagnostic tests, announced today that it currently anticipates its highest quarterly revenue and operating income in its history, driven by global shipments of its QuickVue® Influenza A+B tests in the third quarter of 2009. Demand for its market-leading tests accelerated during the third quarter, consistent with reports of escalating influenza-like illness in the U.S. Since the end of April 2009, the company has continued to manufacture flu tests seven days a week at its facility in San Diego and has the capacity to produce millions of additional tests per month to accommodate customer orders.
Quidel attributes the early demand for its rapid flu tests to a number of factors, as widely reported across the country:
- The U.S. Centers for Disease Control and Prevention’s (CDC) Week 34 Influenza Surveillance Report (for August 23-29, 2009) documented elevated levels of influenza-like illness in several Southeastern states, with all jurisdictions reporting regional or widespread flu activity.
- The American College Health Association (ACHA) reported last week that 54 percent of the 189 colleges and universities that are tracking influenza say they have students with the flu.
- Schools and universities across the country are seeing spikes in the number of students with influenza-like illness as classes begin and students return to dormitories. Washington State University, with approximately 19,000 students, announced it is experiencing the nation’s largest flu outbreak, with 2,000 students impacted just before classes started. The ACHA reported several universities in Georgia combined had the second-highest attack rate or spread of flu-like illness.
- According to the CDC’s Week 34 Influenza Report, the percentage of specimens testing positive for influenza by collaborating laboratories remained unusually higher during the week than is typically seen at this time of year. This may be due to a combination of factors including higher than normal circulation of influenza in the summer with the emergence of the 2009 H1N1 virus, changes in testing practices by healthcare providers, triaging of specimens by public health laboratories, and an increase in the number of specimens collected from outbreaks.
“Quidel has experienced an unprecedented volume of orders by hospital and physician office labs for the QuickVue tests in the third quarter of 2009, coinciding with the start of school. Previously we had anticipated that third quarter flu sales would be solely a factor of physicians initially stocking shelves in preparation for the traditional October through May flu season, but we are already receiving reorders for influenza products, which is activity that we usually see in the fourth and first quarters of the year,” said Douglas Bryant, president and chief executive officer of Quidel. “Despite having delivered a record level of flu tests to customers, we continue to manufacture at high levels given notable increases in non-seasonal demand.”
Bryant continued, “As the incidence of influenza-like illness increased globally earlier this year and awareness of the availability of rapid flu tests increased, we are now seeing widespread use of our rapid flu tests in the management of influenza outbreaks. As we demonstrated in our clinical studies, in 10 minutes or less with a simple nasal swab, our QuickVue Influenza A+B test can detect seasonal influenza A with 94 percent clinical sensitivity and 90 percent specificity compared with culture. This type of product performance is tremendously valuable, aiding physicians in their diagnosis and treatment decisions while helping to diminish the spread of flu.”