New Influenza A/H1N1 detection kit launched

Sep 10 2009

QIAGEN (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA), today announced both the launch of a new Influenza A/H1N1 test and several updates to its activities in providing solutions for the global surveillance of the swine flu pandemic. QIAGEN’s new kit enables both the highly sensitive and specific detection of the novel Influenza A/H1N1, the virus that causes “swine flu”, as well as of all other known Influenza A and B virus strains. The new test kit is a significant addition to QIAGEN’s existing portfolio of products for H1N1 screening and surveillance. It has been designed for use by governments and public health institutions as part of the efforts to identify and control outbreaks of pandemic A/H1N1 Influenza.

The new artus Influenza/H1 RG/LC RT-PCR Kit provides highly accurate results in approximately 40 minutes. This is unlike many current molecular solutions and most antigen-based H1N1 tests, which can either take up to several hours to produce results or, in the case of rapid protein-based tests, have been found to have a low sensitivity in detecting the virus. In addition, QIAGEN’s new kit can also detect infections with other known Influenza A and B strains likely to emerge and disseminate in the population during the upcoming flu season. The rapid turn around time of the company’s new test can result in faster reporting of results which plays a key factor in monitoring and controlling outbreaks. Designed for use with QIAGEN’s automated sample and assay technologies such as the thermo cycler Rotor-Gene Q, the test is also compatible with certain other platforms used in laboratories worldwide, allowing labs to quickly adopt and run it on existing instruments and without the need for additional training.

“With QIAGEN’s new test and our existing solutions to support Tamiflu/Oseltamivir resistance testing, we offer healthcare professionals powerful tools not only to quickly and reliably detect the origin of flu-like symptoms in patients, but also to profile the pathogen and thus to rapidly take the necessary actions to control an outbreak,” said Peer Schatz, CEO of QIAGEN. “In the light of the upcoming flu season and the likely emergence and dissemination of other Influenza A and B strains, these capabilities are vital to effectively fight the further dissemination and the effects of the H1N1 pandemic.”

QIAGEN provides a broad portfolio of solutions for the surveillance of the H1N1 pandemic. These include two real time PCR-based screening tests, a test which detects multiple different pathogens in one single run (so called “multiplex”), and protocols for resistance testing. The company’s solutions include individual sample preparation reagents, enzymes and instrumentation used by labs in testing protocols recommended by international health authorities, including the WHO and the U.S. Centers for Disease Control and Prevention (CDC). This portfolio has become a key contributor to the worldwide efforts to contain the H1N1 pandemic.

In addition, QIAGEN provided further updates on its recent activities in the area of swine flu monitoring:

• During the last few weeks QIAGEN has entered into further, significant supply agreements for consumables and instruments with public health authorities in Europe, Asia, Latin America and other regions. This adds to a large presence already built in the first half of 2009.
• The first customer to order lots of QIAGEN’s new artus Influenza/H1 RG/LC RT-PCR Kit is the government of Saudi Arabia. The government is evaluating the possibility of implementing the screening solution in time to help contain the spread of the virus during the upcoming Mekka pilgrimage.
• The CDC’s protocol for swine flu testing which has recently obtained Emergency Use Authorization by the US FDA includes QIAGEN components. The CDC protocol has now been adopted for the surveillance of swine flu infections in U.S. troops world-wide.
• Additionally, a test protocol for evaluating Influenza A/H1N1 variations is being widely adopted for H1N1 resistance testing against Tamiflu/Oseltamivir. This protocol is based on QIAGEN’s proprietary “Pyrosequencing” assay technology as well as the company’s sample preparation technologies. QIAGEN is seeing significant demand for these solutions as they add significant value as secondary, resistance testing on samples that have been found positive using screening tests. This second line testing is increasingly being added to the front line screening efforts.

QIAGEN had rapidly responded to the initial Influenza A/H1N1 outbreak in April 2009 by quickly validating the ability of its already-available influenza detection technology platforms to identify H1N1 as part of the test’s general Influenza A detection capabilities and has subsequently added a range of additional solutions to help in disease surveillance and management. The rapid support for the current pandemic builds on QIAGEN’s experiences from previous major outbreaks of infectious diseases: QIAGEN is the leading provider of Avian Flu (H5N1) molecular detection tools worldwide and also developed the first test for the detection of SARS. Public health institutions and more than 80 reference laboratories around the globe use the company's molecular tests and testing components for surveillance and research of these viral infections. Worldwide, QIAGEN has the broadest portfolio of molecular screening solutions for viral infectious diseases.

The test kit is available in the United States for research use only. It has not been cleared or approved by authorities including the United States Food and Drug Administration or any other regulatory agency in the United States, or under the European IVD Directive, for human diagnostic or other clinical use, and is not intended and should not be used for human diagnostic or any other clinical purposes.