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The author:(作者)归海一刀
published in(发表于) 2014/2/17 8:56:43
Clinical application of gene sequencing to be reined in， because Steve jobs is known

　　The technology is known for Angelina, Julie jobs using

The Beijing News (reporter Wei Mingyan), State food and drug administration, the National Health Commission recently issued a circular, requiring prior to the access standards, management norms related to the introduction, clinical application of any medical institution shall not carry out genetic sequencing, has been done, to stop immediately. Continued after notice issued, territorial health administrative departments shall be investigated and dealt with according to the law.

In on the gene sequencing information, the most widely known, is the movie star Angelina Jolie. Julie through genetic testing, choose surgery to reduce the risk of breast cancer of the breast; died in 2011 Apple founder Steven. While jobs ' cancer, also received the full gene sequencing. In recent years, gene sequencing in recent years because of "celebrity" is widely used in high-end medical examinations (such as health assessment, early detection of cancer), prenatal diagnosis (such as genetic diseases forecast) fields such as expensive. Some claim that the gene sequencing of individuals medical projects, charging as much as tens of thousands of dollars.

However, the Union of the two ministries and notice that the gene sequencing, including prenatal genetic testing related products and technologies belonging to contemporary cutting-edge technology research areas involving ethics, protection of privacy and human genetic resources, biosafety and gene diagnosis of a medical institution issues such as technical management, price, quality of service monitoring. Currently, gene-sequencing-related products and technologies has evolved from a laboratory research to clinical use, in this regard, the relevant departments under the State Council attaches great importance. To ensure public use gene sequencing to diagnose product safety and efficacy, the State food and drug administration and the national family planning Commission is organizing the relevant experts in the field of health survey demonstration.

Therefore, from the date of publication of the notification, including all genetic sequencing, prenatal genetic testing products and technologies, such as disease prevention, diagnosis, care, treatment, monitoring, evaluation of health status and prediction of genetic disease, needs approval by the food and drug administration, registration, and approved by the Administrative Department of health and family planning access to technology can be applied. Has been applied, must be stopped immediately.

(Original title: my halted clinical application of gene sequencing)

　　该技术因安吉丽娜、朱莉 乔布斯使用过而闻名

　　新京报讯 (记者 魏铭言)国家食药总局、国家卫生计生委日前联合发出通知，要求在相关的准入标准、管理规范出台以前，任何医疗机构不得开展基因测序临床应用，已经开展的，要立即停止。通知下发后仍继续开展的，属地卫生行政部门要依法依规予以查处。

　　在关于基因测序的各种宣传中，最广为人知的，是影星安吉丽娜。朱莉通过基因检测，选择手术切除乳腺以降低患乳腺癌风险；2011年去世的苹果公司创始人史蒂芬。乔布斯患癌时，也曾接受过全基因测序。近年来，基因测序近年来因“名人效应”广泛应用于高端体检(如健康状态评价，癌变早期检测)、产前诊断(如遗传性疾病预测)等领域，价格不菲。有些宣称个人全基因测序的体检项目，收费高达数万元。

　　然而，两部委的联合通知指出，包括产前基因检测在内的基因测序相关产品和技术属于当代前沿技术研究范畴，涉及伦理、隐私和人类遗传资源保护、生物安全以及医疗机构开展基因诊断服务技术管理、价格、质量监管等问题。目前，基因测序相关产品和技术已由实验室研究演变到临床使用，对此，国务院有关部门高度重视。为保证公众使用基因测序诊断产品的安全、有效，国家食药总局和国家卫生计生委正在组织相关领域专家调查论证。

　　因此，自本通知发布之日起，包括产前基因检测在内的所有基因测序产品及其技术，如用于疾病的预防、诊断、监护、治疗监测、健康状态评价和遗传性疾病的预测，需经食品药品监管部门审批注册，并经卫生计生行政部门批准技术准入方可应用。已经应用的，必须立即停止。

(原标题：我国叫停基因测序临床应用)

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