Agendia公司乳腺癌转移危险的检查方法获得ISO认证

 
一种以微阵列（基因芯片）为基础的诊断检查评估了乳腺癌患者肿瘤转移的危险。

这种检测方法叫做MammaPrint，在荷兰Agendia的实验室中进行了操作。这项检测使用了70个基因将乳腺癌进行分类：在10年内出现远处肿瘤转移的低危和高危人群。Agendia的此项服务已经获得了ISO认证。

MammaPrint为肿瘤科医生和乳腺癌患者提供了有关疾病后续治疗有价值的信息，这或许包括对可能出现远处转移的患者进行化疗。在欧洲和美国几个医学中心进行临床研究已经证实，MammPrint比传统的分类方法更加优越，例如当前广泛使用的St. Gallen标准。MammaPrint能够精确鉴别出那些传统方法认为无需治疗的患者，并避免化疗的严重副作用。

Agendia是一家生物技术公司，是荷兰癌症研究院的让产易股公司，在晚期癌症研究方面具有坚实基础。ISO是一种对检测实验室能力进行认证的国际标准。这种认证授予为期4年，在此期间，荷兰认证委员会将对该公司的实验室进行年检，以确保该公司能够达到ISO的所有要求。

Risk Test for Breast Cancer Metastasis
 
A microarray-based diagnostic test assesses the risk of metastasis in breast cancer patients.

Called MammaPrint, the test is administered in the laboratory facilities of Agendia (Amsterdam, The Netherlands). The test uses a 70-gene profile to classify breast cancer patients as having low or high risk of developing distant metastases in a 10-year period. Agendia has received ISO accreditation for the service.

MammaPrint offers valuable information to oncologists and breast cancer patients concerning the subsequent treatment of their disease, which may include chemotherapy for patients at risk of developing metastases. Several studies in medical centers in Europe and the United States have demonstrated that MammaPrint outperforms conventional classifying methods such as the widely used St. Gallen criteria. MammaPrint accurately identifies patients who can be left untreated when evaluated by conventional methods, sparing them the serious side effects of chemotherapy.

Agendia is a biotechnology company that is a spin-off of The Netherlands Cancer Institute and has a strong base in advanced cancer research. ISO is an international standard for the competence of testing laboratories. The accreditation is granted for four years, during which the Dutch Accreditation Council will perform yearly inspections of the company’s laboratory facilities to confirm that the company is conforming to all ISO requirements.