FDA Panel Unanimously Approves Exact Sciences' Colorectal Cancer Test

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FDA Panel Unanimously Approves Exact Sciences' Colorectal Cancer Test

机译：FDA小组一致批准Exact Sciences的结直肠癌测试

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A U.S. Food and Drug Administration (FDA) panel has unanimously recommended Exact Sciences Corp.'s colorectal cancer screening assay be approved for use in the United States, concluding it had demonstrated its safety and effectiveness while demonstrating a favorable risk-benefit profile.

机译：美国食品药品监督管理局（FDA）小组一致建议Exact Sciences Corp.的大肠癌筛查测定法被批准在美国使用，认为它已经证明了其安全性和有效性，同时证明了良好的风险效益。

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《Laboratory industry report》 |2014年第7期|共1页
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正文语种 eng
中图分类经济;
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Unanimously; recommended; demonstrated;

机译：一致;推荐;示范;

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1. FDA Panel Unanimously Approves Exact Sciences' Colorectal Cancer Test [J] . null Laboratory industry report . 2014,第7期

机译：FDA小组一致批准Exact Sciences的结直肠癌测试
2. Exact Sciences Submits Second Module of PMA for DNA Colorectal Cancer Test to FDA - Clinical Lab Products [J] . Clinical Lab Products . 2013,第2013期

机译：Exact Sciences向FDA提交了用于DNA大肠癌测试的PMA的第二个模块-临床实验室产品
3. Analytical Validation of a DNA Dual Strand Approach for an FDA-approved NGS based Praxis Extended RAS Panel for FFPE Metastatic Colorectal Cancer Samples [J] . Lyer A., Udar N., Haigis R., The Journal of molecular diagnostics: JMD . 2018,第6期

机译：用于FFPE转移性结直肠癌样品的FDA批准的基于FDA批准的NGS的DNA双链方法的分析验证
4. UHPLC-HRMS Method for Repurposing FDA Approved Drugs: Primaquine and its Metabolites as Anticancer Therapeutics [C] . Samantha M. Mahmoud, Dil Ramanathan American Society for Mass Spectrometry Conference on Mass Spectrometry and Allied Topics . 2012

机译：用于修复FDA批准的药物的UHPLC-HRMS方法：原序及其代谢产物作为抗癌治疗方法
5. Universal Screening for Familial Colorectal Cancer Syndromes at Seattle Cancer Care Alliance: Qualitative Study of Providers involved in Implementation and Patients Experience with First Wave of Testing [D] . Hyams, Travis. 2016

机译：西雅图癌症护理联盟对家族性结直肠癌综合征的通用筛查：参与实施的提供者的定性研究和第一波测试的患者经验
6. FDA panel conditionally approves DNA pap test without ACOG support. [O] . Adam Ostrzenski 2002

机译：FDA小组有条件地批准了未经ACOG支持的DNA pap测试。
7. ACC/AHA 2002 guideline update for exercise testing: summary article A report of the American college of cardiology/American heart association task force on practice guidelines (committee to update the 1997 exercise testing guidelines) 11The ACC/AHA Task Force on Practice Guidelines makes every effort to avoid any actual or potential conflicts of interest that might arise as a result of an outside relationship or personal interest of a member of the writing panel. Specifically, all members of the writing panel are asked to provide disclosure statements of all such relationships that might be perceived as real or potential conflicts of interest. These statements are reviewed by the parent task force, reported orally to all members of the writing panel at the first meeting, and updated as changes occur.22This document was approved by the American College of Cardiology Foundation Board of Trustees in July 2002 and by the American Heart Association Science Advisory and Coordinating Committee in June 2002. When citing this document, the American College of Cardiology Foundation and the American Heart Association would appreciate the following citation format: Gibbons RJ, Balady GJ, Bricker JT, Chaitman BR, Fletcher GF, Froelicher VF, Mark DB, McCallister BD, Mooss AN, O’Reilly MG, Winters WL Jr. ACC/AHA 2002 guideline update for exercise testing: summary article: a report of the ACC/AHA Task Force on Practice Guidelines (Committee to Update the 1997 Exercise Testing Guidelines). J Am Coll Cardiol 2002;40:1531–40.33Copies: This document is available on the World Wide Web sites of the ACC (www.acc.org) and the AHA (www.americanheart.org). A single copy of the complete guidelines is available by calling 800-253-4636 (US only) or writing the American College of Cardiology, Resource Center, 9111 Old Georgetown Road, Bethesda, MD 20814-1699. Ask for reprint No. 71-0231. To obtain a copy of the Executive Summary published in the October 1, 2002 issue of Circulation, ask for reprint No. 71-0232. To purchase additional reprints (specify version and reprint number): up to 999 copies, call 800-611-6083 (US only) or fax 413-665-2671; 1000 or more copies, call 410-528-4426, fax 410-528-4264, or e-mail kbradle@lww.com.44(J Am Coll Cardiol 2002;40:1531–40.)55©2002 by the American College of Cardiology Foundation and the American Heart Association, Inc. [O] . Gibbons Raymond J, Balady Gary J, Timothy Bricker J, 2002

机译：ACC / AHA 2002年运动测试指南更新：摘要文章美国心脏病学会/美国心脏协会实践指南工作组的报告（委员会对1997年运动测试指南进行了更新）11ACC / AHA实践指南工作组使每一个努力避免由于写作小组成员的外部关系或个人利益而引起的任何实际或潜在的利益冲突。具体来说，要求写作小组的所有成员提供所有可能被视为实际或潜在利益冲突的关系的披露声明。这些声明由上级工作组进行审查，在第一次会议上向书面小组的所有成员口头报告，并在发生变化时进行更新。22本文件于2002年7月获得美国心脏病学会基金会理事会的批准。美国心脏协会科学咨询和协调委员会于2002年6月提出。引用该文件时，美国心脏病学会基金会和美国心脏协会将赞赏以下引用格式：Gibbons RJ，Balady GJ，Bricker JT，Chaitman BR，Fletcher GF， Froelicher VF，Mark DB，McCalister BD，Mooss AN，O'Reilly MG，Winters WL Jr.ACC / AHA 2002锻炼测试指南更新：摘要文章：ACC / AHA实践指南工作组的报告（更新委员会）（1997年运动测试指南）。 J Am Coll Cardiol 2002； 40：1531–40.33副本：该文档可在ACC（www.acc.org）和AHA（www.americanheart.org）的万维网站点上找到。可以通过致电800-253-4636（仅限美国）或写信给美国心脏病学会资源中心（位于贝塞斯达，乔治市老街9111号，马里兰州20814-1699）来获得完整指南的单个副本。要求转载第71-0231号。要获得发表在2002年10月1日的《发行》上的《执行摘要》，请索阅第71-0232号。要购买其他重印本（指定版本和重印本号码）：最多999份，请致电800-611-6083（仅限美国）或传真413-665-2671；否则，请重新发送。 1000份或更多，请致电410-528-4426，传真410-528-4264或电子邮件kbradle@lww.com.44（美国运筹学杂志，2002； 40：1531–40。）55©2002心脏病学基金会基金会和美国心脏协会有限公司
8. Health Care Systems for Tracking Colorectal Cancer Screening Tests: Final Report on the System Approach to Tracking and Increasing Screening for Public Health Improvement of Colorectal Cancer (SATIS-PH/CRC) Intervention [R] . Harris, D. M., Borksy, A. E. 2010

机译：用于跟踪结肠直肠癌筛查测试的医疗保健系统：跟踪和增加结直肠癌公共卫生改善筛查系统方法的最终报告（saTIs-pH / CRC）干预

FDA Panel Unanimously Approves Exact Sciences' Colorectal Cancer Test

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