2012年11月28日国家食品药品监督管理局(SFDA)批准Qiagen新型宫颈疾病诊断试剂careHPV 

 

据QIAGEN介绍，其careHPV检测可筛查高危型人乳头瘤病毒（HPV），是专为资源不足的临床环境而设计的，比如缺乏水、电或现代实验室基础设施。该项检测基于digene杂交捕获（HC）技术，是与非营利性机构PATH合作开发的。

QIAGEN计划2013年1月在中国推出careHPV检测，接着在印度推出，而在获得批准之后，会在其他新兴市场推出。该项检测是在深圳制造的，让“原产国（country of origin）”批准是一个重要的里程碑。许多国家能够在他们自己的监管批准中使用这项SFDA的批准。careHPV将针对亚洲、拉丁美洲、东欧和非洲地区。

据统计，每年大约有27.5万名妇女死于子宫颈癌，其中85%以上是在欠发达国家。许多地区因缺乏水、电或现代实验室基础设施，子宫颈癌筛查的负担很重。为满足这些地区的需求，QIAGEN的careHPV检测包含了多个创新设计和技术特征。例如，系统有着易于理解的菜单，包含试剂，也能够承受一些偏远地区无冷藏设备所带来的温度变化。非医务人员经过几小时的培训即可使用，该检测也能够避免样品的交叉污染。

使用careHPV检测的临床研究已在中国、尼日利亚、卢旺达和泰国开展。研究结果表明了careHPV检测在资源不足环境中的高灵敏度和可靠性。

QIAGEN是全球HPV检测的市场领导者，提供金标准的digene HC2 HPV检测产品，可高度灵敏地检测高危型HPV。digene HC2检测与现代实验室和自动化处理兼容，被广泛应用在发达国家和新兴市场的大城市，包括中国。据QIAGEN介绍，digene HC2检测至今已保护了超过1亿名妇女，是QIAGEN子宫颈癌预防方面的核心产品。careHPV和digene HC2检测都是基于临床验证的杂交捕获技术，是高度互补的，因为它们满足不同实验室的需求。

QIAGEN分子诊断业务的高级副总裁Helge Lubenow表示：“我们正通过在新兴市场推出careHPV系统来扩大QIAGEN的预防产品线。这一新产品补充了我们digene HC2 HPV检测的全球领导地位，也可协同使用，让全国或区域性的筛查项目覆盖目标区域内的所有部分。”


2012 年 12 月 7 日 ——德国凯杰 (QIAGEN) 公司 (以下简称“凯杰”) 近日宣布其careHPV 检测和仪器平台已获中国国家食品药品监督管理局 (SFDA) 批准。careHPV检测是全球首款面向资源匮乏地区高危型人乳头瘤病毒 (HPV) 筛查的分子诊断产品，专为缺少水、电或现代化实验室基础设施等临床环境而设计。相关产品计划于 2013 年 1 月在中国投入生产，印度及其他新兴市场也将在获批之后相继面市。在 11 月 30 日于波多黎各召开的国际乳头瘤病毒 (IPV) 学术会议上介绍了 careHPV检测及其性能的关键数据。

凯杰是全球 HPV 检测市场的领导者， digene HC2 HPV检测产品在检测宫颈癌的主要诱因——高危型人乳头瘤病毒方面具有高可靠性和高灵敏度，被公认为业内的“金标准”。针对近一百万名妇女所进行的临床独立随机研究证明，凯杰 digene HC2 HPV 检测是唯一有效的检测产品。该检测可与现代化实验室和自动化处理相兼容，已被广泛应用于发达国家和中国等新兴市场的大城市，累计已保护了超过1亿名妇女，迄今为止仍是凯杰在宫颈癌预防方面的核心产品。careHPV 和 digene HC2 检测都是基于获得临床验证的杂交捕获技术，两者由于能满足不同实验室环境的需要而具有高度互补性。

凯杰与国际非营利组织 PATH 合作开发出 careHPV 检测，从而推动 HPV 筛查在资源匮乏型市场中的普及。可靠、便携且易于使用的 careHPV 检测、仪器和采集设备适用于基础设施相对落后的地区，患者就诊当日即可获知结果。许多宫颈癌高发地区缺乏水、电或现代化实验室基础设施，为满足这些地区的需要，凯杰的 careHPV 检测包含了多项创新的设计和技术特性。例如，系统含有采用了彩色编码且易于理解的菜单和整合试剂，即使在水电匮乏的偏远地区，也不会因为无法冷藏样本而受到温度的影响。非专业医务人员只需接受几小时的培训即可操作 careHPV 系统，在最严苛的环境中，该检测亦能够避免样品的交叉污染。

凯杰公司分子诊断业务高级副总裁 Helge Lubenow 博士表示：“作为相关领域内唯一一款检测产品，careHPV 为资源匮乏地区的妇女提供了可有效降低宫颈癌威胁的高灵敏度分子诊断技术。全球每年约有 275,000 名妇女死于宫颈癌，其中 85% 以上发生在欠发达国家。我们与 PATH 合作开发的 careHPV 是有望拯救许多妇女生命的宫颈癌预防战略的重要组成部分。凯杰面向新兴市场所推出的 careHPV 系统，通过向医疗保健供应商提供相关产品，同时捐赠给正在实施大规模宫颈癌预防计划的政府和非政府组织 (NGO)，将有力扩充我们的宫颈癌预防产品线。这款新产品可与digene HC2 HPV形成互补，巩固我们的全球领导地位。两者也可协同使用，让全国性或区域性的筛查项目覆盖目标区域内所有不同基础设施条件下的目标群体。”

careHPV 检测由凯杰公司位于中国深圳的工厂生产，此次获得上市许可也使“原产国”获批成为相关产品推广的一个重要里程碑。许多国家能够在各自的监管审批过程中使用 SFDA 的许可，从而避免了冗长且成本高昂的本地监管审批。careHPV 的首批推广将针对亚洲、拉丁美洲、东欧和非洲地区，其临床研究已在中国、尼日利亚、卢旺达和泰国展开，凯杰也同时与 PATH 在中国、印度、乌干达和尼加拉瓜等国合作开展了示范型试验。相关数据显示，careHPV 检测在资源匮乏型地区具有高灵敏度和可靠性。

凯杰公司常年与 NGO 和政府合作开展一项名为 QIAGENcares 的企业社会责任项目，致力于高质量宫颈癌筛查在资源匮乏型地区的推广，此次正式获批的 careHPV检测已在该项目中发挥了重要作用。凯杰承诺捐赠 150 万次 HPV 检测，用以改善全球赤贫国家人民的卫生质量。例如，凯杰已与疫苗生产商默克公司 (Merck & Co., Inc.) 合作，从卢旺达开始，面向贫穷国家设计并开展对抗宫颈癌的综合公共项目，其中的典型案例包括：QIAGENcares 帮助巴西的医务人员在移动装置上安装 careHPV 检测设备，在边远地区开展宫颈癌筛查；萨尔瓦多政府与非营利组织 Basic Health International 开展合作，正在对将 careHPV 整合至一项全国性筛查项目进行评估，该项目同时还采用了面向城市人群、基于 digene HC2 检测的筛查方案；careHPV 也应用在了南非和布基纳法索开展的部分项目中。

如需了解有关 QIAGENcares 的更多信息，请登录以下网址：
www.qiagen.com/about/whoweare/qiagencares/qiagencares.aspx。

关于凯杰
凯杰是一家荷兰上市公司，是全球领先的样本制备和分析技术的供应商。样品制备技术用来分离和处理从血液或组织等样品中提取的 DNA、RNA 和蛋白，而分析技术使这些分离的分子可被检测，便于生物学研究和疾病检测。凯杰已经开发了500多种全面的产品组合，包括试剂和自动化解决方案。凯杰产品的主要客户包括分子诊断实验室、学术研究领域，制药和生物技术公司，应用检测用户（例如法医鉴定，动物和食品检测，以及药物过程控制等）。凯杰的分析技术涵盖最广泛的分子诊断产品，包括在检测宫颈癌主要病因高危型HPV中被称为“金标准”的 digene HC2 HPV检测试剂以及在传染疾病和伴随诊断中广泛应用的配套试剂。截止2012年6月30日，凯杰在全球35个城市拥有约4000 名员工。更多关于凯杰的信息请登陆 http://www.qiagen.com/。

根据《美国证券法1933年修订版》第27A条及《美国证券交易法1934年修订版》第21E条的规定，本新闻稿中包含的某些陈述可能被视为前瞻性声明。本文中包含的任何有关凯杰产品、市场、战略或经营业绩（包括但不限于预期的经营业绩），尤其是台湾和亚洲业务的预计增长的声明在一定程度上均为前瞻性的，这些声明基于目前的预期和假设，包含许多不确定因素和风险。这些不确定性和风险包括但不限于增长管理和国际运营（包括货币波动、监管程序和对物流的依赖等的影响）相关的风险；经营业绩以及业务部门之间分配情况的变动；应用检测市场、个人保健市场、临床研究市场和蛋白质组学市场、妇女健康/ HPV检测市场、基于核酸的分子诊断市场、以及基因疫苗和基因治疗市场的商业发展情况；与客户、供应商和战略伙伴的关係的变化；竞争形势；技术领域快速或意料之外的变革；对凯杰产品的需求的波动（包括由于总体经济形势、客户融资的水平和及时性、预算及其他因素造成的波动）；我们的传染性疾病产品组合获得监管机构核准的能力；改造凯杰产品以集成到综合性解决方桉中和生产这类产品过程中所面临的困难； 凯杰识别新的需求并开发出相应的新产品、与竞争对手的产品差分出来并保护自己的产品的能力；市场对凯杰新产品的接受度；以及整合收购的技术和业务等。如需更多信息，请参阅凯杰已在美国证券交易委员会归档或已提交的报告中的论述。

QIAGEN gains SFDA approval to market careHPV Test in China – expanding access to HPV testing in low-resource countries

• Commercial launch of careHPV in China and other emerging markets will enable high-quality screening for prevention of cervical cancer
• "Country of Origin" approval key for dissemination, other countries are able to use this as a basis for registration
• careHPV is the first HPV test designed for areas with limited healthcare infrastructure, complementing QIAGEN's market-leading digeneHC2 HPV Test

Shenzen, China, and Hilden, Germany, November 28, 2012 - QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced that China's State Food and Drug Administration (SFDA) has approved QIAGEN's careHPV Test and instrument platform. The careHPV Test is the first molecular diagnostic to screen for high risk human papillomavirus (HPV) designed for low-resource clinical settings, such as areas lacking electricity, water or modern laboratory infrastructure. QIAGEN expects to announce the product availability of careHPV in China in January 2013, followed by India later in 2013 and other emerging markets as approvals are received. QIAGEN will introduce the careHPV Test and key data of its performance at the International Papillomavirus (IPV) conference, starting November 30 in Puerto Rico.

QIAGEN is the global market leader in HPV testing with its  "gold standard" digene HC2 HPV Test,  the most validated and sensitive diagnostic for detection of high-risk HPV - a primary cause of cervical cancer. It is the only assay that has demonstrated its effectiveness in close to 1 million women in clinical, randomized and independent studies. The digene HC2 test, compatible with modern laboratories and automated processing, is widely used in developed countries and large cities in emerging markets, including China. The digene HC2 test has protected more than 100 million women so far and remains QIAGEN's core product for cervical cancer prevention. 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.

QIAGEN developed the careHPV Test in collaboration with PATH, an international nonprofit organization, to expand access to HPV screening in low-resource settings. The robust, portable, and easy-to-use careHPV assay, instrument and collection devices are designed for areas with limited infrastructure and can provide results during the patient visit. Many regions with the highest burdens of cervical cancer lack electricity, water or modern laboratory infrastructure. To address the needs in such regions, 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 thecareHPV system, and the test also has been shown to avoid cross-contamination of samples even in the most stringent settings.

"As the only test of its kind, careHPV offers the life-saving benefits of sensitive molecular diagnostics to resource-poor regions. About 275,000 women a year die from cervical cancer, more than 85 percent in less-developed countries. We have teamed with PATH to create careHPV as part of a preventive strategy that will save many women's lives," said Dr. Helge Lubenow, Senior Vice President, Molecular Diagnostics Business Area. "We are expanding QIAGEN's Prevention portfolio by launching the careHPV system in emerging markets, both through a commercial offering to healthcare providers and through donations to governments and NGOs that are in the process of implementing large scale cervical cancer prevention plans. This new product complements our well-established global leadership with the digene HC2 HPV test and can also be used very synergistically for example to allow national or regional screening programs to cover the infrastructure profiles of all segments within the targeted region."

The careHPV Test is manufactured by QIAGEN in Shenzhen, China, making the "country of origin" approval a critical milestone. Many countries are able to use this approval by the SFDA for their own regulatory approval, instead of conducting lengthy and costly local regulatory submissions. ThecareHPV rollout will target areas in Asia, Latin America, Eastern Europe and Africa.

Clinical studies with the careHPV Test have been conducted in China, Nigeria, Rwanda and Thailand in parallel with PATH demonstration trials in China, India, Uganda and Nicaragua. The data demonstrate the high sensitivity and reliability of the careHPV Test in low-resource settings.

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. QIAGEN is committed to donating 1.5 million HPV tests to improve life in the world's poorest nations. 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. The programs have taken many forms: QIAGENcareshas 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 together with screening solutions based on the digene HC2 test which would be used in cities. Projects in South Africa and Burkina Faso have also used careHPV. To learn more about QIAGENcares please visit: www.qiagen.com/about/whoweare/qiagencares/qiagencares.aspx.

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 September 30, 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).