NeoGenomics推出FDA批准的前列腺癌伴随诊断试剂

环球市场播报

Jul 09

　　NeoGenomics公司（纳斯达克代码：NEO）宣布推出PTEN IHC CDx检测试剂，这是美国FDA批准的首款用于前列腺腺癌患者的免疫组织化学伴随诊断试剂。

　　该检测试剂用于识别PTEN蛋白缺失的患者，帮助筛选可能适合接受阿斯利康靶向疗法TRUQAP（capivasertib）治疗的患者。TRUQAP近期已获FDA批准上市。PTEN IHC CDx既可单独下单使用，也可作为NEO PanTracer Pro前列腺癌分子检测套餐的组成部分，该套餐将全面基因组分析与癌症类型导向的免疫组化检测整合为一次订单。

　　该检测由NeoGenomics旗下全国肿瘤实验室网络的病理学家执行，单独下单时通常在一至两天内出具结果，已获纽约州批准使用。

　　NeoGenomics医疗服务副总裁Nathan Montgomery表示，治疗侵袭性前列腺癌的临床医生长期需要靶向疗法及配套的筛选工具，此次将PTEN IHC CDx整合入NEO PanTracer Pro，为社区肿瘤诊所提供了经FDA批准的伴随诊断选择。

　　前列腺癌是美国男性中最常见的恶性肿瘤，每年新增病例超过30万例，死亡人数逾3.6万。每年约3.5万名mAPMN/S前列腺癌患者中，约四分之一存在PTEN缺陷肿瘤，涉及约8，750人。PTEN蛋白缺失可在确诊时通过组织检测识别。

　　NeoGenomics总部位于佛罗里达州迈尔斯堡，是一家专注于肿瘤基因检测与信息服务的癌症诊断公司，运营着全美CAP认证和CLIA认证的实验室网络。

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