阿斯利康與QIAGEN合作開發(fā)血液EGFR試劑盒
時(shí)間：2014-07-30 09:31:30 來源：轉(zhuǎn)哈醫(yī)學(xué)網(wǎng) 點(diǎn)擊：
轉(zhuǎn)化醫(yī)學(xué)網(wǎng)點(diǎn)評(píng)：伴隨全球資本市場(chǎng)對(duì)分子診斷的追捧，國(guó)內(nèi)分子診斷行業(yè)也不斷引爆一個(gè)又一個(gè)熱潮，許多做傳統(tǒng)試劑盒的公司看到了利潤(rùn)的誘惑，毅然決然跳入這一行業(yè)；許多做技術(shù)服務(wù)的企業(yè)，也號(hào)稱可以做腫瘤靶向用藥指導(dǎo)。一時(shí)間，大大小小的公司層出不窮。分子診斷行業(yè)的大幕才剛剛拉開，這不，阿斯利康和QIAGEN也進(jìn)來了，精彩繼續(xù)上演中……
阿斯利康（AZD）7月28日宣布，與德國(guó)QIAGEN（凱杰）簽署合作協(xié)議，開發(fā)一種非侵入性診斷試劑盒，用于確定適合抗癌藥易瑞沙（Iressa）治療的非小細(xì)胞肺癌（NSCLC）患者。
Iressa是一種表皮生長(zhǎng)因子受體（EGFR）酪氨酸激酶抑制劑（TKI），能夠阻斷導(dǎo)致腫瘤生長(zhǎng)的信號(hào)通路。EGFR是一種在許多類型腫瘤細(xì)胞上呈異常高水平表達(dá)的蛋白，尤其是非小細(xì)胞肺癌（NSLCL）。利用QIAGEN公司的診斷試劑盒，醫(yī)生將能夠通過血液檢測(cè)，鑒定攜帶EGFR突變的患者，從而區(qū)分出能夠從Iressa藥物受益最大的患者群體。目前，評(píng)估EGFR突變狀態(tài)的主要方法，涉及穿刺活檢或手術(shù)切除過程中收集腫瘤組織。
QIAGEN的試劑盒，利用了一種高度敏感的技術(shù)，檢測(cè)患者血漿樣品中循環(huán)腫瘤DNA（ctDNA）小片段中的EGFR突變。在IV期IFUM（易瑞沙后續(xù)評(píng)測(cè)）研究中，該試劑盒已表現(xiàn)出強(qiáng)大且可靠的EGFR突變狀態(tài)鑒別能力。
此次合作，是阿斯利康與QIAGEN一項(xiàng)長(zhǎng)期合作關(guān)系的一部分。雙方將共同合作，使該款ctDNA試劑盒獲的歐洲藥品管理局（EMA）批準(zhǔn)，作為Iressa的伴隨診斷試劑盒。
液體活檢（liquid biopsy）是一個(gè)激動(dòng)人心的新領(lǐng)域，同時(shí)也是QIAGEN的核心領(lǐng)導(dǎo)領(lǐng)域，該公司開發(fā)用于處理源自患者體液的腫瘤DNA和RNA的新穎解決方案，目前正與現(xiàn)有和新的分析方法廣泛應(yīng)用于臨床驗(yàn)證，并具有改善不適合微創(chuàng)手術(shù)的患者群體的臨床預(yù)后。
關(guān)于易瑞沙（Iressa）：
易瑞沙（Iressa，通用名：gefitinib，吉非替尼）是一種新穎的小分子量腫瘤治療藥物，其作用機(jī)制主要是通過抑制EGFR自身磷酸化而阻滯傳導(dǎo)，抑制腫瘤細(xì)胞的增殖，實(shí)現(xiàn)靶向治療，該藥于2009年獲歐盟批準(zhǔn)。
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，與德國(guó)QIAGEN（凱杰）簽署合作協(xié)議，開發(fā)一種非侵入性診斷試劑盒，用于確定適合抗癌藥易瑞沙（Iressa）治療的非小細(xì)胞肺癌（NSCLC）患者。
Iressa是一種表皮生長(zhǎng)因子受體（EGFR）酪氨酸激酶抑制劑（TKI），能夠阻斷導(dǎo)致腫瘤生長(zhǎng)的信號(hào)通路。EGFR是一種在許多類型腫瘤細(xì)胞上呈異常高水平表達(dá)的蛋白，尤其是非小細(xì)胞肺癌（NSLCL）。利用QIAGEN公司的診斷試劑盒，醫(yī)生將能夠通過血液檢測(cè)，鑒定攜帶EGFR突變的患者，從而區(qū)分出能夠從Iressa藥物受益最大的患者群體。目前，評(píng)估EGFR突變狀態(tài)的主要方法，涉及穿刺活檢或手術(shù)切除過程中收集腫瘤組織。
QIAGEN的試劑盒，利用了一種高度敏感的技術(shù)，檢測(cè)患者血漿樣品中循環(huán)腫瘤DNA（ctDNA）小片段中的EGFR突變。在IV期IFUM（易瑞沙后續(xù)評(píng)測(cè)）研究中，該試劑盒已表現(xiàn)出強(qiáng)大且可靠的EGFR突變狀態(tài)鑒別能力。
此次合作，是阿斯利康與QIAGEN一項(xiàng)長(zhǎng)期合作關(guān)系的一部分。雙方將共同合作，使該款ctDNA試劑盒獲的歐洲藥品管理局（EMA）批準(zhǔn)，作為Iressa的伴隨診斷試劑盒。
液體活檢（liquid biopsy）是一個(gè)激動(dòng)人心的新領(lǐng)域，同時(shí)也是QIAGEN的核心領(lǐng)導(dǎo)領(lǐng)域，該公司開發(fā)用于處理源自患者體液的腫瘤DNA和RNA的新穎解決方案，目前正與現(xiàn)有和新的分析方法廣泛應(yīng)用于臨床驗(yàn)證，并具有改善不適合微創(chuàng)手術(shù)的患者群體的臨床預(yù)后。
關(guān)于易瑞沙（Iressa）：
易瑞沙（Iressa，通用名：gefitinib，吉非替尼）是一種新穎的小分子量腫瘤治療藥物，其作用機(jī)制主要是通過抑制EGFR自身磷酸化而阻滯傳導(dǎo)，抑制腫瘤細(xì)胞的增殖，實(shí)現(xiàn)靶向治療，該藥于2009年獲歐盟批準(zhǔn)。
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.”
