QIAGEN announces commercial launch of careHPV Test in China
Mar 30 2013

QIAGEN announces commercial launch of careHPV Test in China

  • careHPVTM Test is the first HPV test designed for areas with limited healthcare infrastructure, complementing QIAGEN's market-leading digene HC2 HPV Test
  • Commercial launch of careHPV Test in China and other emerging markets will enable high quality screening for prevention of cervical cancer
  • "Country of Origin" approval and commercial launch key for dissemination, other countries are able to use this as a legal basis for registration and application

BEIJING, China, March 30, 2013 - QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced the official commercial launch of careHPV Test in China. careHPV Test is the world's first molecular diagnostic to screen for high risk human papillomavirus (HPV) for low-resource clinical settings. Low resource settings include areas lacking electricity, water or laboratories. QIAGEN gained the approval from China's State Food and Drug Administration (SFDA) for the careHPV Test at the end of 2012.

Cervical cancer is the second most common cancer among women worldwide. HPV is the first virus to be identified as the primary cause of a cancer, and its very high correlation to cervical cancer has been widely validated. Despite the known causal link that the resulting opportunity to significantly reduce the burden of this disease through the use of both diagnostics and vaccines, there are still approximately 500,000 new cases and more than 270,000 deaths reported each year. Research has shown that 80% of new cases and deaths occur in developing countries, where awareness of the disease and access to preventive tests and medical treatment is low. In many of these low-resource areas, cervical cancer has eclipsed breast cancer as the primary cancer killer of women. The number of new cervical cancer cases in China alone is as high as 140,000 cases annually, accounting for nearly 30% of the total number across the globe. As the most populous country in the world, China has over 600 million women of which approximately 60% are living in less developed areas in the Midwest, where the prevalence of cervical cancer is increasingly higher than in the coastal areas of East China. These regional differences are due to factors such as the strength of the regional economy, its infrastructure, local habits, local prevention and awareness programs, etc. Hence there is the urgent need of a new test which relates to the underdeveloped areas where modern hospital and laboratory infrastructures are not available.

QIAGEN began development of the robust, portable, and easy-to-use careHPV Test in 2003 with support from PATH, an international nonprofit organization, as well as Cancer Institute and Hospital Chinese Academy of Medical Sciences, to expand access to HPV screening in low-resource settings. QIAGEN's careHPV Test includes many innovative design and technology features. For example, the system has color coded, easy to understand menus, contained reagents, and tolerates temperature variations that occur in rural clinics lacking refrigeration for sample storage due to limited electricity or water. Non-medical staff can be trained in hours to use the careHPV system, and the test also has been shown to avoid cross-contamination of samples even in the most stringent settings. The availability of rapid results through the single-visit test enables women at risk for or with cervical cancer, especially those live in remote areas, to be quickly identified.

QIAGEN offers a broad range of products for screening and genotyping of HPV viruses. QIAGEN's digene HC2 HPV Test, the most validated and sensitive diagnostic for detection of high-risk HPV, has long been recognized as the "gold standard" and is widely used in developed countries and large cities in emerging markets. It has protected more than 100 million women so far throughout the world. In China, there are about 1 million women who take digene HC2 HPV Test each year and nearly 10 million Chinese women have benefited from it as of 2013. The careHPV and digene HC2 tests are both based on clinically proven Hybrid Capture technology, and are highly complementary because they serve different laboratory needs. The digene HC2 HPV Test is manufactured in the United States and the careHPV Test is manufactured by QIAGEN in Shenzhen, China. The SFDA approval of the careHPV Test represented a "country of origin" approval and therefore was a critical milestone. Many countries are able to have their local regulatory approvals and applications based on the SFDA approval which thereby avoids lengthy and costly local clinical trials and regulatory submissions.

"The commercial launch of careHPV marks a very significant milestone in helping mitigate the threat of cervical cancer to women in less developed areas. This is the 7th year since QIAGEN entered China and it has become the company's 2rd largest diagnostic market in the world. The careHPV program is a testament to our commitment to China as we are manufacturing careHPV in Shenzhen and also have the first commercial launch here. QIAGEN will be continually devoted to promoting the prevention awareness of careHPV and thereby contribute our share to the health of global women." said Dr. Victor Shi, President of QIAGEN Asia Pacific.

Professor Qiao Youlin, Head of the Department of Epidemiolog, Cancer Institute and Hospital Chinese Academy of Medical Sciences, said, "Most of developing countries cannot live up to the standard of traditional screening methods of cervical cancer. However, the clinical data of careHPV Test proves that it can not only provide accurate results but is also easy to use, which fits into the conditions in these countries. Therefore I believe that careHPV Test will have a promising market opportunity."

Academician Lang Jinghe, the leading authority of Obstetrics and Gynecology in China and Chairman of Society of Gynaecology and Obstetrics of the Chinese Medical Association, said, "Screening serves as an important way to prevent cervical cancer. To develop accurate, efficient and economic HPV screening technologies has been the focus of both academic circles and society. QIAGEN's careHPV Test not only provides high sensitivity and specificity but also fully considers the infrastructure in low-resource regions. It will become a positive attempt to further promote the prevention of cervical cancer."

The careHPV Test already plays a central role in QIAGENcares, the company's collaboration with NGOs and governments to expand access to high-quality cervical cancer screening in resource-poor regions. For example, QIAGEN has partnered with vaccine manufacturer Merck & Co., Inc., to design and implement comprehensive public programs to fight cervical cancer in poor countries, starting in Rwanda. QIAGENcares has also helped clinicians in Brazil install the careHPV device on mobile units to conduct cervical cancer screening in remote areas. El Salvador's government, working with the nonprofit group Basic Health International, is evaluating the integration of careHPV into a national screening program. Projects in South Africa and Burkina Faso have also used careHPV.

To learn more about QIAGENcares please visit: http://www.qiagen.com/About-Us/Who-We-Are/QIAGENcares/

About QIAGEN

QIAGEN N.V., a Netherlands 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 December 31, 2012, QIAGEN employed approximately 4,000 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com/.

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).

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