一種以微陣列(基因芯片)為基礎的診斷檢查評估了乳腺癌患者腫瘤轉移的危險。
這種檢測方法叫做MammaPrint,在荷蘭Agendia的實驗室中進行了操作。這項檢測使用了70個基因將乳腺癌進行分類:在10年內出現遠處腫瘤轉移的低危和高危人群。Agendia的此項服務已經獲得了ISO認證。
MammaPrint為腫瘤科醫生和乳腺癌患者提供了有關疾病后續治療有價值的信息,這或許包括對可能出現遠處轉移的患者進行化療。在歐洲和美國幾個醫學中心進行臨床研究已經證實,MammPrint比傳統的分類方法更加優越,例如當前廣泛使用的St. Gallen標準。MammaPrint能夠精確鑒別出那些傳統方法認為無需治療的患者,并避免化療的嚴重副作用。
Agendia是一家生物技術公司,是荷蘭癌癥研究院的讓產易股公司,在晚期癌癥研究方面具有堅實基礎。ISO是一種對檢測實驗室能力進行認證的國際標準。這種認證授予為期4年,在此期間,荷蘭認證委員會將對該公司的實驗室進行年檢,以確保該公司能夠達到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.
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