QIAGEN to distribute altona Diagnostic’s RealStar® Ebolavirus RT-PCR Kit 1.0, recently authorized by the FDA for emergency use
- New molecular diagnostic test detects but does not differentiate all existing strains of Ebola virus
- Partnership with altona Diagnostics adds to portfolio of QIAGEN products already in use outside the United States by research and clinical laboratories for Ebola diagnostics and research
Hilden, Germany, and Germantown, Maryland, December 04, 2014 – QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced it will offer global distribution of the altona Diagnostics RealStar® Ebolavirus RT-PCR Kit 1.0 after the U.S. Food and Drug Administration amended, on November 26, 2014 to permit authorized distribution and use in US and certain non-US laboratories, an Emergency Use Authorization (EUA) originally issued on November 10, 2014, for this kit. The diagnostic kit, developed and manufactured by altona Diagnostics GmbH, is a reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of RNA from all known strains of Ebolaviruses, including the Zaire strain driving the current Ebola epidemic in West Africa. QIAGEN has agreed to distribute the RealStar® Ebolavirus RT-PCR Kit 1.0 in addition to altona’s already CE-IVD marked test, the RealStar® Filovirus RT-PCR Kit, which is for both Ebola and Marburg viruses and does not fall under the EUA.
“QIAGEN is taking an active role in the world’s fight against Ebola, building on our capabilities as a leading provider of testing solutions demonstrated in previous outbreaks. We are making Ebola diagnostic workflows accessible to public health authorities, scientists and healthcare providers through our commercial networks around the world, including in Africa,” said Peer M. Schatz, Chief Executive Officer of QIAGEN. “We are now also providing the RealStar® Ebolavirus kit for altona Diagnostics to help stop this deadly epidemic.”
The RealStar® Ebolavirus kit is authorized for emergency use on specified instruments in plasma from individuals with signs and symptoms of Ebolavirus infection in conjunction with clinical and epidemiological risk factors. As authorized by the FDA under EUA, the test has not been FDA cleared or approved. It has been authorized by the FDA under an Emergency Use Authorization for use by CLIA High Complexity Laboratories and similarly qualified non-U.S. laboratories and only for the detection – not differentiation – of RNA from Ebolaviruses (such as Zaire ebolavirus, (including the Zaire ebolavirus strain detected in the West Africa outbreak 2014], Sudan ebolavirus, Tai Forest ebolavirus, Bundibugyo ebolavirus, and Reston ebolavirus) and not for any other viruses or pathogens. Furthermore, this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of Ebola Zaire virus under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
QIAGEN’s agreement with altona Diagnostics to distribute the FDA-authorized RealStar® Ebolavirus RT-PCR Kit 1.0 expands an existing collaboration between the two companies which was signed in the third quarter of 2014. Under the earlier agreement, QIAGEN is also distributing the RealStar® Filovirus RT-PCR Kit, which does not fall under the EUA, outside the United States. This highly sensitive test for Filoviruses (Ebola and Marburg) that is CE-IVD marked for use on QIAGEN instruments and with QIAGEN sample technologies outside the United States is also compatible with other widely used detection platforms present in many laboratories, helping to avoid the need for new equipment and additional trainings.
Other QIAGEN molecular testing technologies not covered by the EUA include components such as the EZ1 Virus Mini Kit v2.0, RNeasy and QIAamp Viral RNA Mini extraction kits as well as flexible automation platforms such as the QIAsymphony family, QIAcube and EZ1 Advanced instruments, which are being used by many laboratories around the world for Ebola research and diagnosis. Finally, QIAGEN’s bioinformatics tools such as the CLC Genomics Workbench and Ingenuity Pathway Analysis have contributed to generating valuable insights into research on genetic factors driving individual response to Ebola infections.
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample & Assay Technologies that are used to transform biological materials into valuable molecular information. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are then used to make these isolated biomolecules visible and ready for interpretation. QIAGEN markets more than 500 products around the world, selling both consumable kits and automation systems to customers through four customer classes: Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharmaceutical and biotechnology companies) and Academia (life sciences research). As of September 30, 2014, QIAGEN employed approximately 4,200 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
About altona Diagnostics GmbH
altona Diagnostics, founded in 2007 in Hamburg, Germany, is focused on the development, approval, manufacturing, and marketing of molecular diagnostic test systems for the detection and quantification of pathogens. Altona is a fully integrated diagnostic company. The founders and staff of altona Diagnostics have a broad experience in molecular diagnostics and corresponding technologies. Among other activities, they were among the first to make reliable CE-IVD marked molecular diagnostic kit systems commercially available during outbreak situations for SARS, avian Flu, swine Flu and EHEC. altona Diagnostics is ISO 13485 certified.
Certain of the statements contained in this news release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, markets, strategy or operating results, including without limitation its expected operating results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products in applied testing, personalized healthcare, clinical research, proteomics, women's health/HPV testing and nucleic acid-based molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors' products; market acceptance of QIAGEN's new products, the consummation of acquisitions, and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).