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保证患者定制个人化疗时DNA检查正确性的标准方法
2020-11-15 [96151]
本文摘要:华盛顿——星期四,美国联邦政府明确提出了保证患者定制个人化疗时DNA检查正确性的标准方法,可以说关闭了基因药物迈向新时代的大门scientistshaveidentifiedhundredsofgeneticmutationsthatappeartoincreasetheriskofdiseases,includingcancer,Alzheimer’sandcysticfibrosis

Washington-thefederalgovernmentopenedthedoortoaneweraofgeneticmedicineonthursdaybyintroducingastandardwaytoensuretheaccuration atmentsforindividualpatients .华盛顿——星期四,美国联邦政府明确提出了保证患者定制个人化疗时DNA检查正确性的标准方法,可以说关闭了基因药物迈向新时代的大门scientistshaveidentifiedhundredsofgeneticmutationsthatappeartoincreasetheriskofdiseases,including cancer, Alzheimer’sandcysticfibrosis.butlaboratoriesoftenreportdifferentresultswhentheyanalyzegenesobtainedfromsamplesofthesamples SSS becauseofvariationsintheirtestingequipmentandmethods .科学家们现在认识到,有数百个遗传变异可以降低特定疾病(包括癌症、老年痴呆症、囊性纤维化等)的风险。但是,由于检查设备和方法的不同,在分析从同一血液和组织样品中提取的基因时,经常没有报告不同的结果。

thenationalinstituteofstandardsandtechnologysaidthursdaythaddeveloped“参考材料”thatcouldbeusedbylaboration rmin softwarewereproperlyanalyzingaperson’sgeneticblueprint是or genome .美国国家标准技术研究所(nationalinstituteofstandardsandtechnology )在星期四每个实验室都可以用来确认自己的机器和软件是否能正确分析一个人的基因计划图。theinstitutedisseminatessuchreferencematerialsforthousandsofproductsincludingsteel, concreteandpeanutbutter.thesematerialsareusedformyriadpurposes-tocalibrateinstruments,to make sure buildings are safe。toensurethatnutritionallabelsareaccurate .该研究所将标准材料推广到钢铁、水泥、花生酱等数千种产品中,用于它们,以保证校正设备、建筑物的安全性、保证营养标签的正确性等laboratoriescanusethenewdnastandardtomakesuretheirgenetictestingisaccurate.iflabsgettherightanswersforthereferencematerial Finn esameplaces,for example-theycanbeconfidentthattheirtestingofpatientsamplesissimilarlyaccuration实验室在检查基准材料时将“正确答案”—— thedevicesusedbythelaboratories,known as DNA sequencers, havegreatlyacceleratedbiomedicalresearchanddiscovery, allowingscientiststopinpointmutationsanddevisetreatmentstailoredtothegeneticcharacteristicsofindividualpatients.suchtestsaaal developedinresearchlaboratories,arequicklymovingintothepracticeofmedicine .实验室中,将分担这种工作的设备称为DNA测序器,有了它科学家们就在这里inhisstateoftheunionaddressthisyear是, presidentobamaannounceda“precisionmedicineinitiative”tofosterthedevelopmentandadoptionofsuchcustomizedtreatments .或奥巴马总统 For $450,scientistsandlaboratoriescannowbuyavialofthereferencematerialfromthenationalstandardsinstitute,aunitofthecommercede forsaleontheagency’s website是include S10 microgramsofdnafromautahwomanofeuropeanancestry.thatisenoughfornumeroustests .的标准材料nstitute )的网站上销售,现在科学家们和实验室只需450美元就可以卖给部分瓶子。

实验室

其中包括来自犹他州的欧裔女性的10微克DNA,已经完成了足够多次的检查。“ifyousendasampleofbloodoratumorbiopsytodifferentgenetictestinglaboratories,you can get different results,”saidmarcl。theleaderofagenomemeasurementgroupattheinstitute .“whilelargelyinagreement,theymayhavesignificantdifferences.now”for the firse wehaveastandardtocheckthereliabilityandqualityofgenesequencing .”“将血液或肿瘤的前列腺样品送到不同的基因检测实验室,可能会得到不同的结果。

化疗

“几乎完全一致,但可能没有明显的区别。现在,我们有了第一个可以检测基因测序质量和可靠性的(统一的)标准。》alaboratorycanusethesamplestodemonstratethequalityofitswork, andhealthinsurancecompaniescanhaveconfidenceintheresults是increasingthelikelihoodthattheywillpayforgenome-sequencing tests,DD butitstillcostsabout $ 5,000 toanalyzeandinterpretawholegenome .萨利兹博士表示,实验室可以用这个样本证明自己的工作质量,医疗保险公司也对检查结果不自信,格他还补充说,虽然近年来测序成本有所上升,但对所有基因组的分析和理解仍然必须在5000美元左右。

Elizabeth A. Mansfield,ageneticistatthefoodanddrugadministrationwhosupervisesitsworkonpersonalizedmedicine, saidthereferencematerialcouldleadto“betterinstrumentsandbettertests .”asaresult, she said是“healthplansmaybemorewillingtopayforsuchtests .”美国食品药品监督管理局(Food and Drug Administration,F.D.A.)的遗传学家伊丽莎白就这样”。thef.d.a.workedwiththestandardsinstitutetodevelopthednareferencematerial, whichgivesregulatorsanewtooltoassessto“aninaccurategenome-sequencingtestcanleadtopatientsreceivingthewrongdiagnosis, thewrongtreatmentornotreatmentatall,evenwheneffectivetherapyisavailable,“said Dr. Jeffrey E. Shuren, directorofthef.d.a.centerfordevicesandradiologicalhealth.accuratetestshavebecomemoreimportant,he said, astreatmentsareincreasinglybasedonthetypeofmutationsdetectedingenetictesting.f.d.a .医疗设备和电磁辐射身体健康中心(centerfordevices) alth 主任杰弗里e施雷(Jeffrey E. Shuren )说:“不正确的基因组测序检查可能导致患者接受错误的临床、拒绝错误的化疗、没有有效的化疗手段却不能接受化疗。

” 他说,因为化疗的方法是基于基因检查发现的变异型,所以基因检查的精度越来越重要。Dr. Francis S. Collins,directorofthenationalinstitutesofhealth, saidthatinformationfromthetestscouldbenefitpatientsinmanyways .“for example,”he said, “anoncologistmightusetheresultsofasequencingscantochoosethechemotherapydrugthatismostlikelytowork .”美国国立公共卫生研究院(national ii ) on “例如,肿瘤科医生可以用于测序结果,自由选择可能效果最差的化疗药物。

美国

科学家们

》theregulationofdnatestsandtechnologyiscomplicatedandinflux.DNA检查及其技术的监督管理非常复杂,发生了变化。One agency,thecentersformedicareandmedicaidservices,regulatesandcertifiesclinicallaboratoriesundera 1988 LAW.thef . asisteragencyinthesamedepartment,regulates manufacturers andhasauthorityovertheactualtests.thefoodanddrugagencyhashistoricallyrefrainedfromenforcingsomeofitsrequirementsfor“lab ble elor ”including many genetic tests,butitproposedtooverhaulandtightenregulationoftheseproductslastyear.1988年称医疗和医疗救助服务中心(ce 与该机构同属同一部门的姐妹机构的F.D.A .与监督管理制造商已经负责简单的检查。F.D.A .近年来没有强制执行一些对“实验室开发的检查”(包括许多基因检查)的拒绝,但该机构去年明确提出,不应该完善和加强对这些产品的监督管理。

thenewreferencematerialisforteststhatuseadvancedtechnology -“next-generation sequencing”- toanalyzeaperson’sdds lyinterpretedbs andnotsolddirectlytoconsumers .新推出的标准材料仅限于使用先进设备的“下一代测序”技术,分析了个人DNA的检查。这种检查的结果一般需要卖给消费者,必须得到医生和遗传咨询师的理解。In 2013,thefoodanddrugagencytoldasiliconvalleycompany,23andMe, tostopsellinghealthinformationreportsthatinterpretedaperson’SDNA.in February, itallowedthecompanytoofferadirect-to-consumertesttohelpidentifycarriersofagenelinkedtoaspecificraredisorder, bloomserver今年2月,该公司又批准后,为了识别与类似罕见疾病——布卢姆综合征(Bloom syndrome )相互连锁的基因携带者,需要接受面向消费者的检查。

The food and drug agency、expectingawaveofnewtechnologytoanalyzethehumangenome、helpedfinancetheworkofscientistsandengineeersatthess。


本文关键词:鸭脖娱乐,检查,科学家们,美国,基因检查,材料

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