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腾讯登录Qiagen:新型HPV检测试剂盒及相关设备平台获得SFDA批准
| 导读 | Qiagen公司周三收市后宣布，其careHPV检测试剂盒及先关设备平台已获得中国国家食品药品监督管理局（SFDA）批准。
Qiagen公司表示，careHPV检测将于2013年1月在中国正式上市销售，其次是印度，然后其他新兴市场。相关技术平台的生产，在中国深圳完成。<span><span>Qiagen公司表示，careHPV测试的目的是筛选出高危型HPV，值得一提的... |
Qiagen公司周三收市后宣布，其careHPV检测试剂盒及先关设备平台已获得中国国家食品药品监督管理局（SFDA）批准。
Qiagen公司表示，careHPV检测将于2013年1月在中国正式上市销售，其次是印度，然后其他新兴市场。相关技术平台的生产，在中国深圳完成。<span><span>Qiagen公司表示，careHPV测试的目的是筛选出高危型HPV，值得一提的是，这个是专门为落后地区设计的检测平台，如那些缺乏电力、水及相关础设施资源不足的国家和地区。该技术平台是和</span><span>一个国际性的非赢利组织（PATH）合作开发的。<!--more--></span></span>
<div><br/><strong>The <em>digene</em> HPV 检测－有效预防宫颈癌</strong><br/>
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<div align="justify">
全世界每年宫颈癌的新发病例大约有500,000，是除乳腺癌之外威胁女性生命健康的第二大恶性肿瘤。HPV和宫颈癌的病因学关系已经明确，从HPV感染到宫颈癌发生需要较长时间，在此期间通过检测可以了解是否感染HPV，早发现早治疗，从而有效预防宫颈癌的发生。
The digene HPV Test是临床领域高危型人乳头瘤病毒(HPV)检测的金标准。该方法1999年获得美国FDA的许可，已经在国内外专业期刊发表了300多篇文献，超过825,000女性参与了临床验证研究，全球范围内超过40,000,000致癌HPV检测是使用该方法。
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<br/><strong>英文原文</strong><br/>
：
Qiagen announced after the close of the market Wednesday that it has received China State Food and Drug Administration approval for its careHPV Test and instrument platform.
Qiagen said that the careHPV test is the first molecular diagnostic to screen for high-risk human papillomavirus designed specifically for low-resource clinical settings, such as those lacking electricity, water, or modern laboratory infrastructure. The test is based on the digene Hybrid Capture technology and was developed in collaboration with PATH, an international nonprofit organization.
Among the features of the test system are color-coded, easy to understand menus, contained reagents, and an ability to tolerate temperature variations occurring in rural clinics lacking refrigeration for sample storage.
Qiagen said that it intends to launch the careHPV test in China in January 2013, followed by India later in the year and in other emerging markets as approvals are received. The test is manufactured by Qiagen at its facilities in Shenzhen.
"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," Helge Lubenow, SVP of Qiagen's Molecular Diagnostics Business Area, said in a statement. "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 was part of an alliance announced earlier this year with Merck to provide cervical cancer screening and HPV vaccination in Rwanda.
<br/>来源：http://www.genomeweb.com/clinical-genomics/qiagen-gets-china-ok-new-hpv-test
Qiagen公司表示，careHPV检测将于2013年1月在中国正式上市销售，其次是印度，然后其他新兴市场。相关技术平台的生产，在中国深圳完成。<span><span>Qiagen公司表示，careHPV测试的目的是筛选出高危型HPV，值得一提的是，这个是专门为落后地区设计的检测平台，如那些缺乏电力、水及相关础设施资源不足的国家和地区。该技术平台是和</span><span>一个国际性的非赢利组织（PATH）合作开发的。<!--more--></span></span>
<div><br/><strong>The <em>digene</em> HPV 检测－有效预防宫颈癌</strong><br/>
</div>
<div align="justify">
全世界每年宫颈癌的新发病例大约有500,000，是除乳腺癌之外威胁女性生命健康的第二大恶性肿瘤。HPV和宫颈癌的病因学关系已经明确，从HPV感染到宫颈癌发生需要较长时间，在此期间通过检测可以了解是否感染HPV，早发现早治疗，从而有效预防宫颈癌的发生。
The digene HPV Test是临床领域高危型人乳头瘤病毒(HPV)检测的金标准。该方法1999年获得美国FDA的许可，已经在国内外专业期刊发表了300多篇文献，超过825,000女性参与了临床验证研究，全球范围内超过40,000,000致癌HPV检测是使用该方法。
</div>
<br/><strong>英文原文</strong><br/>
：
Qiagen announced after the close of the market Wednesday that it has received China State Food and Drug Administration approval for its careHPV Test and instrument platform.
Qiagen said that the careHPV test is the first molecular diagnostic to screen for high-risk human papillomavirus designed specifically for low-resource clinical settings, such as those lacking electricity, water, or modern laboratory infrastructure. The test is based on the digene Hybrid Capture technology and was developed in collaboration with PATH, an international nonprofit organization.
Among the features of the test system are color-coded, easy to understand menus, contained reagents, and an ability to tolerate temperature variations occurring in rural clinics lacking refrigeration for sample storage.
Qiagen said that it intends to launch the careHPV test in China in January 2013, followed by India later in the year and in other emerging markets as approvals are received. The test is manufactured by Qiagen at its facilities in Shenzhen.
"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," Helge Lubenow, SVP of Qiagen's Molecular Diagnostics Business Area, said in a statement. "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 was part of an alliance announced earlier this year with Merck to provide cervical cancer screening and HPV vaccination in Rwanda.
<br/>来源：http://www.genomeweb.com/clinical-genomics/qiagen-gets-china-ok-new-hpv-test
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