阿斯利康与QIAGEN合作开发血液EGFR试剂盒
时间：2014-07-30 09:31:30 来源：转哈医学网 点击：
转化医学网点评：伴随全球资本市场对分子诊断的追捧，国内分子诊断行业也不断引爆一个又一个热潮，许多做传统试剂盒的公司看到了利润的诱惑，毅然决然跳入这一行业；许多做技术服务的企业，也号称可以做肿瘤靶向用药指导。一时间，大大小小的公司层出不穷。分子诊断行业的大幕才刚刚拉开，这不，阿斯利康和QIAGEN也进来了，精彩继续上演中……
阿斯利康（AZD）7月28日宣布，与德国QIAGEN（凯杰）签署合作协议，开发一种非侵入性诊断试剂盒，用于确定适合抗癌药易瑞沙（Iressa）治疗的非小细胞肺癌（NSCLC）患者。
Iressa是一种表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKI），能够阻断导致肿瘤生长的信号通路。EGFR是一种在许多类型肿瘤细胞上呈异常高水平表达的蛋白，尤其是非小细胞肺癌（NSLCL）。利用QIAGEN公司的诊断试剂盒，医生将能够通过血液检测，鉴定携带EGFR突变的患者，从而区分出能够从Iressa药物受益最大的患者群体。目前，评估EGFR突变状态的主要方法，涉及穿刺活检或手术切除过程中收集肿瘤组织。
QIAGEN的试剂盒，利用了一种高度敏感的技术，检测患者血浆样品中循环肿瘤DNA（ctDNA）小片段中的EGFR突变。在IV期IFUM（易瑞沙后续评测）研究中，该试剂盒已表现出强大且可靠的EGFR突变状态鉴别能力。
此次合作，是阿斯利康与QIAGEN一项长期合作关系的一部分。双方将共同合作，使该款ctDNA试剂盒获的欧洲药品管理局（EMA）批准，作为Iressa的伴随诊断试剂盒。
液体活检（liquid biopsy）是一个激动人心的新领域，同时也是QIAGEN的核心领导领域，该公司开发用于处理源自患者体液的肿瘤DNA和RNA的新颖解决方案，目前正与现有和新的分析方法广泛应用于临床验证，并具有改善不适合微创手术的患者群体的临床预后。
关于易瑞沙（Iressa）：
易瑞沙（Iressa，通用名：gefitinib，吉非替尼）是一种新颖的小分子量肿瘤治疗药物，其作用机制主要是通过抑制EGFR自身磷酸化而阻滞传导，抑制肿瘤细胞的增殖，实现靶向治疗，该药于2009年获欧盟批准。
英文原文：AstraZeneca and QIAGEN enter collaboration to develop diagnostic test for lung cancer patients suitable for treatment with IRESSA
Monday, 28 July 2014
AstraZeneca today announced that it has entered into a collaboration with Netherlands-based QIAGEN to develop a non-invasive diagnostic test to identify non-small cell lung cancer (NSCLC) patients who are suitable for treatment with IRESSA®.
IRESSA is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor that blocks the signals from the EGFR, which leads to tumour growth. EGFR is a protein found in abnormally high levels on the surface of many types of cancer cells, particularly non-small cell lung cancer (NSCLC) cells. Using QIAGEN’s diagnostic test, doctors will be able to identify patients with the EGFR mutation, and therefore who might benefit most from treatment with IRESSA, through a blood test. Currently the main method of assessing EGFR mutation status involves the collection of tumour tissue by needle biopsy or during resection.
QIAGEN’s test uses a highly sensitive assay to detect EGFR mutations in the small fragments of circulating tumour DNA (ctDNA) in plasma taken from patients’ blood samples. The test has demonstrated robust and reliable identification of EGFR mutation status using samples from the Phase IV IRESSA Follow Up Measure (IFUM) study.
This collaboration is part of a long standing relationship between AstraZeneca and QIAGEN. The two companies are seeking approval from the European Medicines Agency for the ctDNA test, as a companion diagnostic for IRESSA.
Mondher Mahjoubi, Senior Vice President, Global Product Strategy for Oncology at AstraZeneca, said: “By combining AstraZeneca’s expertise in lung cancer with QIAGEN’s diagnostic capabilities, we have the potential to transform the way specific tumour types are identified and treated. The use of circulating tumour DNA testing will allow doctors to target the individual needs of each patient quickly and accurately.”
“We are excited about this new partnership with AstraZeneca”, said Peer M. Schatz, CEO of QIAGEN. “Liquid biopsies are an exciting new field in sample technology and an area of core leadership for QIAGEN. We are rapidly expanding our portfolio in this field and are seeing a broad uptake of our new standards. Our novel solutions for processing tumor DNA and RNA from body fluids are being widely validated for clinical use with existing and new assays and have the potential to improve outcomes for patients for whom invasive surgery is not an option.”
阿斯利康（AZD）7月28日宣布，与德国QIAGEN（凯杰）签署合作协议，开发一种非侵入性诊断试剂盒，用于确定适合抗癌药易瑞沙（Iressa）治疗的非小细胞肺癌（NSCLC）患者。
Iressa是一种表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKI），能够阻断导致肿瘤生长的信号通路。EGFR是一种在许多类型肿瘤细胞上呈异常高水平表达的蛋白，尤其是非小细胞肺癌（NSLCL）。利用QIAGEN公司的诊断试剂盒，医生将能够通过血液检测，鉴定携带EGFR突变的患者，从而区分出能够从Iressa药物受益最大的患者群体。目前，评估EGFR突变状态的主要方法，涉及穿刺活检或手术切除过程中收集肿瘤组织。
QIAGEN的试剂盒，利用了一种高度敏感的技术，检测患者血浆样品中循环肿瘤DNA（ctDNA）小片段中的EGFR突变。在IV期IFUM（易瑞沙后续评测）研究中，该试剂盒已表现出强大且可靠的EGFR突变状态鉴别能力。
此次合作，是阿斯利康与QIAGEN一项长期合作关系的一部分。双方将共同合作，使该款ctDNA试剂盒获的欧洲药品管理局（EMA）批准，作为Iressa的伴随诊断试剂盒。
液体活检（liquid biopsy）是一个激动人心的新领域，同时也是QIAGEN的核心领导领域，该公司开发用于处理源自患者体液的肿瘤DNA和RNA的新颖解决方案，目前正与现有和新的分析方法广泛应用于临床验证，并具有改善不适合微创手术的患者群体的临床预后。
关于易瑞沙（Iressa）：
易瑞沙（Iressa，通用名：gefitinib，吉非替尼）是一种新颖的小分子量肿瘤治疗药物，其作用机制主要是通过抑制EGFR自身磷酸化而阻滞传导，抑制肿瘤细胞的增殖，实现靶向治疗，该药于2009年获欧盟批准。
英文原文：AstraZeneca and QIAGEN enter collaboration to develop diagnostic test for lung cancer patients suitable for treatment with IRESSA
Monday, 28 July 2014
AstraZeneca today announced that it has entered into a collaboration with Netherlands-based QIAGEN to develop a non-invasive diagnostic test to identify non-small cell lung cancer (NSCLC) patients who are suitable for treatment with IRESSA®.
IRESSA is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor that blocks the signals from the EGFR, which leads to tumour growth. EGFR is a protein found in abnormally high levels on the surface of many types of cancer cells, particularly non-small cell lung cancer (NSCLC) cells. Using QIAGEN’s diagnostic test, doctors will be able to identify patients with the EGFR mutation, and therefore who might benefit most from treatment with IRESSA, through a blood test. Currently the main method of assessing EGFR mutation status involves the collection of tumour tissue by needle biopsy or during resection.
QIAGEN’s test uses a highly sensitive assay to detect EGFR mutations in the small fragments of circulating tumour DNA (ctDNA) in plasma taken from patients’ blood samples. The test has demonstrated robust and reliable identification of EGFR mutation status using samples from the Phase IV IRESSA Follow Up Measure (IFUM) study.
This collaboration is part of a long standing relationship between AstraZeneca and QIAGEN. The two companies are seeking approval from the European Medicines Agency for the ctDNA test, as a companion diagnostic for IRESSA.
Mondher Mahjoubi, Senior Vice President, Global Product Strategy for Oncology at AstraZeneca, said: “By combining AstraZeneca’s expertise in lung cancer with QIAGEN’s diagnostic capabilities, we have the potential to transform the way specific tumour types are identified and treated. The use of circulating tumour DNA testing will allow doctors to target the individual needs of each patient quickly and accurately.”
“We are excited about this new partnership with AstraZeneca”, said Peer M. Schatz, CEO of QIAGEN. “Liquid biopsies are an exciting new field in sample technology and an area of core leadership for QIAGEN. We are rapidly expanding our portfolio in this field and are seeing a broad uptake of our new standards. Our novel solutions for processing tumor DNA and RNA from body fluids are being widely validated for clinical use with existing and new assays and have the potential to improve outcomes for patients for whom invasive surgery is not an option.”
