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本文摘要:WASHINGTON — The federal government opened the door to a new era of genetic medicine on Thursday by introducing a standard way to ensure the accuracy of DNA tests used to tailor treatments for individual patients.华盛顿——星期四,美国联邦政府明确提出了一种标准方法,用作保证患者自定义个体化化疗时的DNA检测的准确性,可以说道,此举关上了通向基因药物新时代的大门。

WASHINGTON — The federal government opened the door to a new era of genetic medicine on Thursday by introducing a standard way to ensure the accuracy of DNA tests used to tailor treatments for individual patients.华盛顿——星期四,美国联邦政府明确提出了一种标准方法,用作保证患者自定义个体化化疗时的DNA检测的准确性,可以说道,此举关上了通向基因药物新时代的大门。Scientists have identified hundreds of genetic mutations that appear to increase the risk of diseases, including cancer, Alzheimer’s and cystic fibrosis. But laboratories often report different results when they analyze genes obtained from samples of the same blood or tissue, because of variations in their testing equipment and methods.科学家们现辨识出有数百个有可能减少特定疾病(还包括癌症、阿尔茨海默氏症、囊性纤维化等)风险的遗传变异。但是,由于有所不同的实验室在检测设备和方法上的差异,他们在分析从同一血液或的组织样本中萃取的基因时,经常不会报告有所不同的结果。

The National Institute of Standards and Technology said Thursday that it had developed “reference materials” that could be used by laboratories to determine whether their machines and software were properly analyzing a person’s genetic blueprint, or genome.美国国家标准技术研究所(National Institute of Standards and Technology)在周四声称,自己研发出有了“基准材料”,各实验室可用于它来确认自己的仪器和软件能否正确地分析一个人的遗传蓝图,也就是基因组。The institute disseminates such reference materials for thousands of products including steel, concrete and peanut butter. These materials are used for myriad purposes — to calibrate instruments, to make sure buildings are safe, to ensure that nutritional labels are accurate.该研究所将基准材料推展到了钢铁、水泥和花生酱等数千种产品,用于它们来构建各式各样的目的,如校准仪器、保证建筑物的安全性、保证营养标签的准确性等等。Laboratories can use the new DNA standard to make sure their genetic testing is accurate. If labs get the right answers for the reference material — by finding the same mutations in the same places, for example — they can be confident that their testing of patient samples is similarly accurate.实验室可利用这种新的DNA标准物来保证他们基因检测的准确性。


如果实验室在检测基准材料时得出结论了“准确答案”——例如,在某种程度的位点找到了某种程度的变异,则可以指出他们测试患者样本时也具备类似于的准确性。The devices used by the laboratories, known as DNA sequencers, have greatly accelerated biomedical research and discovery, allowing scientists to pinpoint mutations and devise treatments tailored to the genetic characteristics of individual patients. Such tests and treatments, developed in research laboratories, are quickly moving into the practice of medicine.在实验室中,分担这类工作的设备称作DNA测序仪,有了它,科学家们就可以准确地定位变异,并针对患者个体的遗传特征量身打造出个性化化疗,很大地增进了生物医学研究和找到。这类测试和化疗方法虽问世于研究性实验室,但迅速就转入了医疗实践中领域。

In his State of the Union address this year, President Obama announced a “precision medicine initiative” to foster the development and adoption of such customized treatments.在今年的国情咨文中,奥巴马总统宣告了“精准医疗计划(precision medicine initiative)”,目的增进此类自定义化疗方法的研发和应用于。For $450, scientists and laboratories can now buy a vial of the reference material from the national standards institute, a unit of the Commerce Department. The material, for sale on the agency’s website, includes 10 micrograms of DNA from a Utah woman of European ancestry. That is enough for numerous tests.这种基准材料在美国商务部的下属单位美国国家标准学会(national standards institute)的网站上销售,现在,科学家们和实验室花450美元就可以卖到部分瓶,其中所含来自犹他州的一名欧洲血统女子的10微克DNA,充足已完成多次检测。“If you send a sample of blood or a tumor biopsy to different genetic testing laboratories, you can get different results,” said Marc L. Salit, the leader of a genome measurement group at the institute. “While largely in agreement, they may have significant differences. Now, for the first time, we have a standard to check the reliability and quality of gene sequencing.”“如果你把一份血液或肿瘤前列腺样本送往有所不同的基因检测实验室,你可能会获得有所不同的结果,”该研究所基因组测量小组的负责人马克·L·萨利兹(Marc L. Salit)说道。



”A laboratory can use the samples to demonstrate the quality of its work, and health insurance companies can have confidence in the results, increasing the likelihood that they will pay for genome-sequencing tests, Dr. Salit said. Costs have come down in recent years, he added, but it still costs about $5,000 to analyze and interpret a whole genome.萨利兹博士说道,实验室可以用于该样本证明自己工作的质量,医疗保险公司也不会对检测结果更加有信心,为基因组测序检测收费的可能性也就更大。他还补足道,虽然近年来测序成本有所上升,但全基因组的分析和理解仍必须5000美元上下。

Elizabeth A. Mansfield, a geneticist at the Food and Drug Administration who supervises its work on personalized medicine, said the reference material could lead to “better instruments and better tests.” As a result, she said, “health plans may be more willing to pay for such tests.”美国食品和药品监督管理局(Food and Drug Administration, F.D.A.)的遗传学家伊丽莎白·A·曼斯菲尔德(Elizabeth A. Mansfield)负责管理监管个体化医疗方面的工作,她回应基准材料将不会“提高仪器和检测”。这样一来,“医保计划将更加不愿为此类检测收费。”The F.D.A. worked with the standards institute to develop the DNA reference material, which gives regulators a new tool to assess the accuracy of tests.该DNA基准材料由F.D.A.和标准学会联合开发,它也给了监管部门一个评估检测准确性的新工具。“An inaccurate genome-sequencing test can lead to patients receiving the wrong diagnosis, the wrong treatment or no treatment at all, even when effective therapy is available,” said Dr. Jeffrey E. Shuren, director of the F.D.A. Center for Devices and Radiological Health. Accurate tests have become more important, he said, as treatments are increasingly based on the type of mutations detected in genetic testing.F.D.A.医疗器械和电磁辐射身体健康中心(Center for Devices and Radiological Health)主任杰弗里·E·苏瑞(Jeffrey E. Shuren)说道:“不精确的基因组测序检测可造成患者受到错误的临床、拒绝接受错误的化疗或是在明明不存在有效地化疗手段之时没能获得化疗。

”他还说道,由于化疗方法于是以更加多地以基因检测找到的变异类型为依据,基因检测的准确度于是以显得日益最重要。Dr. Francis S. Collins, director of the National Institutes of Health, said that information from the tests could benefit patients in many ways. “For example,” he said, “an oncologist might use the results of a sequencing scan to choose the chemotherapy drug that is most likely to work.”美国国立公共卫生研究院(National Institutes of Health)院长法兰西斯·S·柯林斯(Francis S. Collins)博士回应,在基因检测中取得的信息可以从诸多方面为患者获取助益。


“例如,肿瘤科医生可以用于测序结果来自由选择效果可能会最差的化疗药物。”The regulation of DNA tests and technology is complicated and in flux.DNA检测及其技术的监管非常复杂,而且变来变去。One agency, the Centers for Medicare and Medicaid Services, regulates and certifies clinical laboratories under a 1988 law. The F.D.A., a sister agency in the same department, regulates manufacturers and has authority over the actual tests. The food and drug agency has historically refrained from enforcing some of its requirements for “laboratory-developed tests,” including many genetic tests, but it proposed to overhaul and tighten regulation of these products last year.根据1988年的法律,医疗医疗和医疗救助服务中心(Centers for Medicare and Medicaid Services)负责管理临床实验室的管理和证书。


The new reference material is for tests that use advanced technology — “next-generation sequencing” — to analyze a person’s DNA. Such tests are generally interpreted by doctors or genetic counselors and not sold directly to consumers.新的发售的基准材料限于于使用了先进设备的“下一代测序”技术来分析个人DNA的检测。此类检测的结果一般来说会必要出售给消费者,而是必须经过医生或遗传咨询师的理解。In 2013, the food and drug agency told a Silicon Valley company, 23andMe, to stop selling health information reports that interpreted a person’s DNA. In February, it allowed the company to offer a direct-to-consumer test to help identify carriers of a gene linked to a specific rare disorder, Bloom syndrome.2013年,F.D.A.通报硅谷的23andMe公司停止销售所含经理解的个人DNA信息的身体健康报告。

今年2月,该机构却又批准后这家公司获取一种必要面向消费者的检测,以协助辨识与一类似的少见疾病——布卢姆综合征(Bloom syndrome)互为连锁的基因的携带者。The food and drug agency, expecting a wave of new technology to analyze the human genome, helped finance the work of scientists and engineers at the standards institute in Gaithersburg, Md.F.D.A.预计,新一波的人类基因组分析浪潮将要兴起,并为马里兰州盖瑟斯堡市标准学会的科学家和工程师们的工作获取了部分资助。