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Veritas公司特殊的myBRCA检测技术获欧洲CE认证

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Veritas Genetics今日宣布,他们公司用于遗传性乳腺癌和卵巢癌的myBRCA筛查技术已经获得了欧洲CE标志。

  Veritas Genetics今日宣布,他们公司用于遗传性乳腺癌和卵巢癌的myBRCA筛查技术已经获得了欧洲CE认证。
  因此总部在波士顿的Veritas公司计划在首批选择的15个国家开展相关的检测服务,尽管目前公司还未透露着15个国家,但是基于唾液的myBRCA检测技术将会以高达99.9%的准确率对BRCA1和BRCA2基因的突变进行检测,而且研究结果还会同数据库中超过50万患者和8000个未知突变进行对比分析。
  Veritas公司的CEO Mirza Cifric表示,同欧洲的肿瘤研究者进行合作,我们将在多个种族人群中证实myBRCA技术的可靠性,从而使得该技术成为一种深入的检测技术,尤其是针对欧洲人群。
  目前Veritas公司也是BRCA检测领域的新秀,公司在两个半月前发起了myBRCA检测技术,检测仅需199美元,而且并不需要保险审批,但需要经过医生批准,每进行一次myBRCA测试,Veritas公司都将会将收入捐赠给患者进行别的检测。(转化医学网360zhyx.com)
  以上为转化医学网原创翻译整理,转载请注明出处和链接!
转化医学网推荐的原文摘要:

Veritas' myBRCA Test Gets CE Mark
Veritas Genetics today said that its myBRCA screening test for hereditary breast and ovarian cancer has received CE marking in Europe.

As a result, the Boston-based firm plans to make the test available in a select group of 15 countries, it said, though it did not disclose which 15 countries. The saliva-based test identifies mutations in the BRCA1 and BRCA2 genes with 99.99 percent accuracy, according to Veritas, and results are compared with a database representing more than 500,000 patients and 8,000 known mutations.

"Working closely with European oncology researchers, we validated myBRCA across ethnicities, making this a very comprehensive test especially for [the] European population," Veritas CEO Mirza Cifric said.

The company is a new entrant into BRCA testing, having launched myBRCA about two-and-a-half months ago. The cost of the test is $199 and does not need insurance approval, though a doctor requisition is needed. For every paid myBRCA test performed, Veritas will donate another test to a patient.

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