江苏省技术产权交易市场

一种DNA点突变定量检测试剂盒
152人浏览
挂牌 挂牌开始时间: 2021-12-16 剩余时间:20月
商品编号
45486200222525530990
商品权属
自有
转让方式
技术转让
价格
¥ 200,000 元

店铺信息

苏州大学附属第一医院
电话 189xxxx5252
以吉非替尼为代表的酪氨酸激酶抑制剂,是临床最为成功的晚期肺癌靶向治疗药物,通过抑制EGFR酪氨酸激酶或抑制肿瘤生长。非小细胞肺癌患者EGFR基因上18/19/20/21外显子上的突变与吉非替尼等酪氨酸激酶抑制剂的疗效显著相关。因此,美国国立综合癌症网络(NCCN)指南和中国卫生部公布的抗肿瘤药物临床应用指导原则均规定,酪氨酸激酶抑制剂前要先对患者EGFR基因的突变情况进行检测,根据突变检测结果制定个体化的靶向药物治疗方案。
本发明开发了EGFR C797S、EGFR T790M、EGFR L858R和EGFR 19外显子缺失等共8个EGFR热点突变位点的检测试剂盒,试剂盒的扩增灵敏度为1-10 拷贝/反应,突变检测灵敏度为1‰-0.1‰,且可通过标准曲线的方式进行定量。可以实现对血浆和组织中EGFR突变进行定量检测。
<p style="margin-top:8px;margin-right:0;margin-bottom:8px;margin-left:0;line-height:130%"><strong><span style="font-size:16px;line-height:130%;font-family:宋体">一、</span></strong><strong><em><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">EGFR</span></em></strong><strong><span style="font-size:16px;line-height: 130%;font-family:宋体">基因突变检测的临床意义</span></strong><strong></strong></p><p style="margin-top:8px;margin-right:0;margin-bottom:8px;margin-left:0;text-indent:32px;line-height:130%"><span style="font-size:16px;line-height:130%;font-family: 宋体">以吉非替尼为代表的酪氨酸激酶抑制剂,是临床最为成功的晚期肺癌靶向治疗药物,通过抑制</span><em><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">EGFR</span></em><span style="font-size:16px;line-height:130%;font-family:宋体">酪氨酸激酶或抑制肿瘤生长。非小细胞肺癌患者</span><em><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">EGFR</span></em><span style="font-size:16px;line-height:130%;font-family:宋体">基因上</span><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">18/19/20/21</span><span style="font-size:16px;line-height:130%;font-family:宋体">外显子上的突变与吉非替尼等酪氨酸激酶抑制剂的疗效显著相关。因此,美国国立综合癌症网络(</span><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">NCCN</span><span style="font-size:16px;line-height:130%;font-family:宋体">)指南和中国卫生部公布的抗肿瘤药物临床应用指导原则均规定,酪氨酸激酶抑制剂前要先对患者</span><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">EGFR</span><span style="font-size:16px;line-height:130%;font-family:宋体">基因的突变情况进行检测,根据突变检测结果制定个体化的靶向药物治疗方案。</span></p><p style="margin-top:8px;margin-right:0;margin-bottom:8px;margin-left:0;line-height:130%"><strong><span style="font-size:16px;line-height:130%;font-family:宋体">二、现有</span></strong><strong><em><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">EGFR</span></em></strong><strong><span style="font-size:16px;line-height: 130%;font-family:宋体">基因检测试剂盒现状</span></strong><strong></strong></p><p style="margin-top:8px;margin-right:0;margin-bottom:8px;margin-left:0;text-indent:32px;line-height:130%"><span style="font-size:16px;line-height:130%;font-family: 宋体">组织中的</span><em><span style="font-size:16px;line-height:130%;font-family: &#39;Times New Roman&#39;,&#39;serif&#39;">EGFR</span></em><span style="font-size:16px;line-height:130%;font-family:宋体">突变含量丰富,大部分突变检测方法只要特异性能大于</span><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">1%</span><span style="font-size:16px;line-height:130%;font-family:宋体">,就能实现对组织中的</span><em><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">EGFR</span></em><span style="font-size:16px;line-height:130%;font-family:宋体">突变检测。但是<em>,</em></span><em><span style="font-size:16px;line-height:130%;font-family: &#39;Times New Roman&#39;,&#39;serif&#39;">EGFR</span></em><span style="font-size:16px;line-height:130%;font-family:宋体">的突变在血液中含量很低(约几十拷贝),且与大量野生型</span><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">DNA</span><span style="font-size:16px;line-height:130%;font-family:宋体">共存(≤</span><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">0.1%</span><span style="font-size:16px;line-height:130%;font-family:宋体">)。野生型</span><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">DNA</span><span style="font-size:16px;line-height:130%;font-family:宋体">的干扰就要求血浆</span><em><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">EGFR</span></em><span style="font-size:16px;line-height:130%;font-family:宋体">突变检测方法必须具有很高的灵敏度与特异性,能够从大量的野生型</span><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">DNA</span><span style="font-size:16px;line-height:130%;font-family:宋体">中扩增和检测出微量的突变型</span><em><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">EGFR</span></em><span style="font-size:16px;line-height:130%;font-family:宋体">。因此,理想的血浆</span><em><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">EGFR</span></em><span style="font-size:16px;line-height:130%;font-family:宋体">突变检测方法需要具有高敏度和高特异性可定量的特点。常用的血浆</span><em><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">EGFR</span></em><span style="font-size:16px;line-height:130%;font-family:宋体">突变检测方法有</span><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">Sanger</span><span style="font-size:16px;line-height:130%;font-family:宋体">测序法(特异性</span><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">&gt;10%</span><span style="font-size:16px;line-height:130%;font-family:宋体">),</span><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">ARMS PCR</span><span style="font-size:16px;line-height:130%;font-family:宋体">(特异性</span><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">1%</span><span style="font-size:16px;line-height:130%;font-family:宋体">左右),数字化</span><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">PCR</span><span style="font-size:16px;line-height:130%;font-family:宋体">(特异性</span><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">&lt; 0.1%</span><span style="font-size:16px;line-height:130%;font-family:宋体">),二代测序技术(特异性</span><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">0.1-1%</span><span style="font-size:16px;line-height:130%;font-family:宋体">)等,这些方法要么特异性难以满足血浆</span><em><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">EGFR</span></em><span style="font-size:16px;line-height:130%;font-family:宋体">突变的检测需求(</span><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">Sanger</span><span style="font-size:16px;line-height:130%;font-family:宋体">测序法,</span><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">ARMS PCR</span><span style="font-size:16px;line-height:130%;font-family:宋体">),要么仪器试剂成本高且操作复杂(数字化</span><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">PCR</span><span style="font-size:16px;line-height:130%;font-family:宋体">和二代测序技术),因此临床依然缺乏一种高灵敏、高特异、可定量、简单、低成本的血浆</span><em><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">EGFR</span></em><span style="font-size:16px;line-height:130%;font-family:宋体">突变检测方法。</span></p><p style="margin-top:8px;margin-right:0;margin-bottom:8px;margin-left:0;line-height:130%"><strong><span style="font-size:16px;line-height:130%;font-family:宋体">三、本发明的主要内容</span></strong><strong></strong></p><p style="margin-top:8px;margin-right:0;margin-bottom:8px;margin-left:0;text-indent:32px;line-height:130%"><span style="font-size:16px;line-height:130%;font-family: 宋体">本发明基于双重</span><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">PNA</span><span style="font-size:16px;line-height:130%;font-family:宋体">钳制反应介导的</span><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">LNA-PNA</span><span style="font-size:16px;line-height:130%;font-family:宋体">钳制</span><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">PCR</span><span style="font-size:16px;line-height:130%;font-family:宋体">技术(</span><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">LNA-dPNA PCR clamp</span><span style="font-size:16px;line-height:130%;font-family: 宋体">),开发了</span><em><span style="font-size:16px;line-height:130%;font-family: &#39;Times New Roman&#39;,&#39;serif&#39;">EGFR</span></em><span style="font-size: 16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;"> C797S</span><span style="font-size:16px;line-height:130%;font-family:宋体">、</span><em><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">EGFR</span></em><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;"> T790M</span><span style="font-size:16px;line-height:130%;font-family:宋体">、</span><em><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">EGFR</span></em><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;"> L858R</span><span style="font-size:16px;line-height:130%;font-family:宋体">和</span><em><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">EGFR </span></em><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">19</span><span style="font-size:16px;line-height:130%;font-family:宋体">外显子缺失等共</span><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">8</span><span style="font-size:16px;line-height:130%;font-family:宋体">个</span><em><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">EGFR</span></em><span style="font-size:16px;line-height:130%;font-family:宋体">热点突变位点的检测试剂盒,试剂盒的扩增灵敏度为</span><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">1-10 </span><span style="font-size:16px;line-height:130%;font-family:宋体">拷贝</span><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">/</span><span style="font-size:16px;line-height:130%;font-family:宋体">反应,突变检测灵敏度为</span><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">1</span><span style="font-size:16px;line-height:130%;font-family:宋体">‰</span><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">-0.1</span><span style="font-size:16px;line-height:130%;font-family:宋体">‰,且可通过标准曲线的方法进行定量。可以实现对血浆和组织中</span><em><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">EGFR</span></em><span style="font-size:16px;line-height:130%;font-family:宋体">突变进行定量检测。此外,该试剂盒只需要普通实时荧光</span><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">PCR</span><span style="font-size:16px;line-height:130%;font-family:宋体">仪器,且在</span><span style="font-size:16px;line-height:130%;font-family:&#39;Times New Roman&#39;,&#39;serif&#39;">3</span><span style="font-size:16px;line-height:130%;font-family:宋体">小时内就能得到检测结果,试剂成本低,可实现对样品的快速、低成本检测。</span></p><p><br/></p>
商品类型 专利 申请号 2017111640414 所属行业 暂缺
专利类型 发明 法律状态 有权 IPC分类号 C12Q1/6886(2018.01)I
交易方式 技术转让 专利状态 已授权 授权号 ZL 2017 1 1164041.4
技术领域 生物与新医药 医药生物技术 有效期至 长久有效 授权日 2021-05-11
暂无数据

购买意向调查