Thirty-eight genetic tests for 48 different cancers have been introduced since 2006, according to a draft report by the U.S. Agency for Healthcare Research and Quality.
The AHRQ conducted a survey of diagnostics for the Centers for Medicare and Medicaid Services. The report, “Update on Horizon Scans of Genetic Tests Currently Available for Clinical Use in Cancers,” will be used as a reference for internal CMS discussions and to help make decisions on future topics for systematic reviews.
Included in the AHRQ’s survey: genetic variations, panels of genetic markers, measurements of gene expression and transcription products, biochemical biomarkers, topographic genotyping, and cytogenetic tests.
The tests fell into three categories. They were either approved by the U.S. Food and Drug Administration or pending approval; conducted in certified labs; or available through the Internet but requiring a physician order.
The largest number of tests is for breast cancer; there were nine, used for prognostic and diagnostic purposes and for therapeutic management. There are also three pharmacogenetic tests for breast cancer. The AHRQ identified six tests for colorectal cancer and four for prostate cancer.
By contrast, only 2 of the 38 tests are for lung cancer.
While aiming to be exhaustive, the survey might not have captured every test available or on the horizon, said the AHRQ in the report. “Genetic testing is a rapidly emerging field with the potential to dramatically influence clinical decision making. Health care providers, patients, payers, decision makers, and consumers can benefit from staying abreast of newly released tests,” concluded the agency.
The draft report will be finalized after the comment period, which ended Jan. 14.
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据美国卫生保健研究与质量管理局(AHRQ)的报告草案，自2006年开始，已针对48种不同癌症提出38项基因检测项目。
AHRQ受美国医疗保险与医疗补助服务中心(CMS)委托，进行了一项诊断调查并形成题为“目前临床癌症可采用的基因检测总览”( Update on Horizon Scans of Genetic Tests Currently Available for Clinical Use in Cancers)的报告草案。该报告将作为CMS内部讨论的参考资料，并有助于确定未来开展系统评价的议题。
AHRQ调查的项目包括：基因变异、系列遗传标记物、基因表达和转录产物测定、生化生物标记物、定位基因分型以及细胞遗传学检测。检测项目可分为3类：已获得FDA批准或待批准的检测；在有资质的实验室可实施的检测；可通过互联网获得但需医嘱的检测。其中用于乳腺癌的检测项目最多，包括9项预后评估、诊断和治疗检测， 还有3项药物基因检测项目。用于结直肠癌和前列腺癌检测的项目分别有6项和4项。相比之下，38项检测项目中仅有2项用于肺癌。
AHRQ在报告中称，尽管力求做到全面，但此次调查或许未能涵盖所有目前或即将可利用的检测项目。基因检测是一个快速兴起的领域，可能会对临床决策产生重大影响。医务人员、患者、付费者、决策制定者以及消费者应及时了解最新发布的检测项目，可从中获益。
该报告草案征求意见截止日期为1月14日，届时将形成终稿。
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