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腾讯登录乳腺癌遗传风险预测公司Color Genomics获批CAP/CLIA 认证
| 导读 | 近日，乳腺癌遗传风险预测公司Color Genomics获得了CAP/CLIA认证，这位癌症的风险预测，又打开了一扇希望之门。 |
Color Genomics近日已经从美国病理学协会（CAP）获得了Certeficate认证，其位于柏林盖姆的临床实验室也通过了相关检测。为了获得CAP的认证，实验室必须证明其具有最高标准的质量、准确性和一致性。CAP对实验室的验证过程会着重检查实验室的几个部分：实验的验证数据，项目管理质量，样品跟踪程序，实验室人员资格和实验室设备，安全性是兼容的，只有这样，实验室才能通过检查。
2015年4月，Color Genomics推出了其Color检测：一个临床级别的病理学指向的基因检测，其可以检测与乳腺癌和卵巢癌风险相关的19个基因，其中考扩了BRCA1和BRCA2。所有的Color检测都包括了遗传咨询，患者无需支出额外的费用。CAP实验室认证项目是一个国际公认的旨在帮助临床实验室达到卓越的项目，同时其要求实验室遵从相关的法规。CAP认证项目的目的是增加实验室给个人带来的价值。CAP项目通过严格高标准的控制实验室的科学严谨性、准确性、可靠性和质量一致性来达到其期望的目标。因为它的综合性质，医疗保险和医疗补助服务中心（CMS）已经授予CAP实验室认证项目，并认为通过其认证的实验室具有检查和授权的权威性。该程序也被联合委员会所认可，并可以用来满足许多国家和国家认证的要求。
Color Genomics高标准的质量也获得了CLIA（临床实验室改进修正案）的认证。此外，Color Genomics在研究个性化乳腺癌筛查中，也获得了加州大学雅典娜WISDOM项目1410万美元的资助。“能够获得CAP的认证，我们感到非常自豪，”Color Genomics基因组学实验室主任Dianne Keen-Kim博士这样说。“这个认证证明了Color之前的承诺-使用最高质量的检测标准，返回质量，精度和可靠性卓越的结果。”
原文链接：
Color Genomics has received a certificate of accreditation from the College of American Pathologists (CAP) following inspection of its clinical laboratory facility in Burlingame, CA. In order to receive CAP accreditation, a laboratory must demonstrate that it operates with the highest standards of quality, accuracy and consistency. The CAP inspection process investigates several components of the laboratory: assay validation data, quality management program, sample tracking procedures, lab personnel qualifications, facilities, safety, and having a lab that is compliant and ready for inspection.Color Genomics launched in April 2015 to offer the Color Test: a clinical-grade, physician-ordered genetic test for 19 genes related to breast and ovarian cancer risk, including BRCA1 and BRCA2. All Color testing includes genetic counseling at no additional cost.
The CAP Laboratory Accreditation Program is an internationally recognized program designed to help clinical labs achieve excellence beyond that which is required for regulatory compliance. The goal of the CAP accreditation program is to increase the value that laboratories bring to individuals. The CAP program does this by holding laboratories to a high standard of scientific rigor, accuracy, reliability and consistent quality. Because of its comprehensive nature, the Centers for Medicare and Medicaid Services (CMS) has granted the CAP Laboratory Accreditation Program deeming authority to inspect and accredit clinical laboratories. The program is also recognized by the Joint Commission, and can be used to meet many state as well as international certification requirements.
Color Genomics’ high standards of quality also led to CLIA (Clinical Laboratory Improvement Amendments) certification. In addition, Color was selected as the genomics partner for the multi-year $14.1 million-funded University of California Athena WISDOM study on personalized breast cancer screening. “We’re proud to obtain this accreditation from CAP,” said Dianne Keen-Kim, Ph.D., FACMG, Laboratory Director at Color Genomics. “This recognition demonstrates Color’s unwavering commitment to applying the highest quality testing standards and returning results of exceptional quality, accuracy and reliability.”（转化医学网360zhyx.com）
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