喜讯!华大基因肺癌高通量测序多基因检测试剂盒获批,国产高通量测序仪走进肿瘤临床

2019-10-03 佚名 华大科技

2019 年 8 月 29 日,国家药品监督管理局官网公示,深圳华大基因股份有限公司(股票代码:300676)全资子公司华大生物科技(武汉)有限公司生产的 “EGFR/KRAS/ALK 基因突变联合检测试剂盒(联合探针锚定聚合测序法)”,通过三类医疗器械产品的注册审批(国械注准 20193400621)。

2019 年 8 月 29 日,国家药品监督管理局官网公示,深圳华大基因股份有限公司(股票代码:300676)全资子公司华大生物科技(武汉)有限公司生产的 “EGFR/KRAS/ALK 基因突变联合检测试剂盒(联合探针锚定聚合测序法)”,通过三类医疗器械产品的注册审批(国械注准 20193400621)。

该试剂盒的获批,打破了国外测序仪在肿瘤基因检测试剂盒领域的垄断局面 ,意味着国产高通量测序仪以其核心技术和过硬质量在肿瘤临床领域实现重大突破。


打破国外测序仪在肿瘤基因检测试剂盒领域的垄断局面

该试剂盒用于定性检测非小细胞肺癌患者 FFPE 组织样本中 EGFR/KRAS/ALK 基因变异,可用于吉非替尼、盐酸埃克替尼、克唑替尼药物的非小细胞肺癌适应症的伴随诊断检测。其对于 EGFR、KRAS 基因突变和 ALK 融合的检测限均为 1%, 达到了国内领先水平。可在 3 款华大基因测序仪 上使用,搭载自动化建库和报告解读系统,可实现从样本到报告的全自动化流程,满足临床用户的多样化和个性化需求。


尹烨

华大基因 CEO

“华大成立二十年以来,始终秉承‘基因科技造福人类 ’的愿景,立志将精准医疗普惠到千家万户。目前肿瘤的精准诊疗技术发展很快,然而新技术、新方法价格高居不下,伴随诊断普及率仍然偏低,患者难以从中获益。故此次获批后,我们将迅速 致力于国产高通量测序设备和试剂盒的全面推广,结合多年来的适合中国用户的大数据积累,持续推进测序技术在肿瘤临床的应用 。 让更多医生和患者从国产高通量检测技术中获益,为健康中国 2030 贡献坚实的自主科技力量。”

华大基因作为中国基因行业的奠基者,秉承“基因科技造福人类”的愿景,通过近 20 年的人才积聚、科研积累和产业积淀,已建成覆盖全球百余个国家和全国所有省市自治区的营销服务网络,成为屈指可数的覆盖本行业全产业链、全应用领域的科技公司,立足技术先进、配置齐全和规模领先的多组学产出平台,已成为全球屈指可数的基因大数据中心、科学技术服务提供商和精准医疗服务运营商。

公司主营业务为通过基因检测、质谱检测、生物信息分析等多组学大数据技术手段,为科研机构、企事业单位、医疗机构、社会卫生组织等提供研究服务和精准医学检测综合解决方案。华大基因以推动生命科学研究进展、生命大数据应用和提高全球医疗健康水平为出发点,基于基因领域研究成果及精准检测技术在民生健康方面的应用,致力于加速科技创新,减少出生缺陷,加强肿瘤防控,抑制重大疾病对人类的危害,实现精准治愈感染,全面助力精准医学。

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    2020-03-11 tastas
  3. 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  4. [GetPortalCommentsPageByObjectIdResponse(id=1969437, encodeId=7952196943ec1, content=<a href='/topic/show?id=6532102e6059' target=_blank style='color:#2F92EE;'>#高通量#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=102760, encryptionId=6532102e6059, topicName=高通量)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ad7f282, createdName=yang0210, createdTime=Wed Feb 05 14:51:00 CST 2020, time=2020-02-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1991080, encodeId=a2e1199108081, content=<a href='/topic/show?id=69bd91e371a' target=_blank style='color:#2F92EE;'>#试剂盒#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91737, encryptionId=69bd91e371a, topicName=试剂盒)], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=47c5349, createdName=tastas, createdTime=Wed Mar 11 10:51:00 CST 2020, time=2020-03-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1934647, encodeId=0d03193464eea, content=<a href='/topic/show?id=325762560c5' target=_blank style='color:#2F92EE;'>#检测试剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=62560, encryptionId=325762560c5, topicName=检测试剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e572480, createdName=旅苦化文_208, createdTime=Fri Mar 06 00:51:00 CST 2020, time=2020-03-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1992623, encodeId=3ca919926238d, content=<a href='/topic/show?id=b9f562561a1' target=_blank style='color:#2F92EE;'>#检测试剂盒#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=62561, 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objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=102764, encryptionId=14bf102e64c1, topicName=高通量测序)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=28a536265959, createdName=医生2406, createdTime=Mon Aug 17 08:51:00 CST 2020, time=2020-08-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1461164, encodeId=1ea4146116413, content=<a href='/topic/show?id=931f35895c0' target=_blank style='color:#2F92EE;'>#华大基因#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=35895, encryptionId=931f35895c0, topicName=华大基因)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b1406387834, createdName=andy2089, createdTime=Sat Oct 05 13:51:00 CST 2019, time=2019-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=373505, encodeId=1ecd3e350595, content=学习了,谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220115/46bcf39c32de4aa6b45c5f9d66c8ee77/6cb4a20c55bb4b7691122f47747bfca2.jpg, createdBy=9dad1662329, createdName=1ddf0692m34(暂无匿称), createdTime=Fri Oct 04 08:39:52 CST 2019, time=2019-10-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=373504, encodeId=4ce23e35041c, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/08/03/0e492dda8bcc1f98474b74c2863aca87.jpg, createdBy=068d2446376, createdName=Dr Z, createdTime=Fri Oct 04 07:45:52 CST 2019, time=2019-10-04, status=1, ipAttribution=), 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  5. [GetPortalCommentsPageByObjectIdResponse(id=1969437, encodeId=7952196943ec1, content=<a href='/topic/show?id=6532102e6059' target=_blank style='color:#2F92EE;'>#高通量#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=102760, encryptionId=6532102e6059, topicName=高通量)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ad7f282, createdName=yang0210, createdTime=Wed Feb 05 14:51:00 CST 2020, time=2020-02-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1991080, encodeId=a2e1199108081, content=<a href='/topic/show?id=69bd91e371a' target=_blank style='color:#2F92EE;'>#试剂盒#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91737, encryptionId=69bd91e371a, topicName=试剂盒)], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, 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objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=102764, encryptionId=14bf102e64c1, topicName=高通量测序)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=28a536265959, createdName=医生2406, createdTime=Mon Aug 17 08:51:00 CST 2020, time=2020-08-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1461164, encodeId=1ea4146116413, content=<a href='/topic/show?id=931f35895c0' target=_blank style='color:#2F92EE;'>#华大基因#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=35895, encryptionId=931f35895c0, topicName=华大基因)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b1406387834, createdName=andy2089, createdTime=Sat Oct 05 13:51:00 CST 2019, time=2019-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=373505, encodeId=1ecd3e350595, content=学习了,谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220115/46bcf39c32de4aa6b45c5f9d66c8ee77/6cb4a20c55bb4b7691122f47747bfca2.jpg, createdBy=9dad1662329, createdName=1ddf0692m34(暂无匿称), createdTime=Fri Oct 04 08:39:52 CST 2019, time=2019-10-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=373504, encodeId=4ce23e35041c, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/08/03/0e492dda8bcc1f98474b74c2863aca87.jpg, createdBy=068d2446376, createdName=Dr Z, createdTime=Fri Oct 04 07:45:52 CST 2019, time=2019-10-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=373497, encodeId=b95a3e34976d, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6d551998554, createdName=1e1c07bdm01(暂无匿称), createdTime=Fri Oct 04 05:26:40 CST 2019, time=2019-10-04, status=1, ipAttribution=)]
    2020-02-04 syscxl
  6. 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  7. 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  8. 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    2019-10-04 1ddf0692m34(暂无匿称)

    学习了,谢谢分享

    0

  9. 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    2019-10-04 Dr Z

    学习了

    0

  10. 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