美国食品药品管理局批准Promega的OncoMate MSI Dx为Keytruda伴随诊断：以PCR检测实体瘤微卫星不稳定性
威斯康星州麦迪逊市消息，美国食品药品管理局已批准 Promega 的 OncoMate MSI Dx 分析系统作为伴随诊断，用于识别微卫星不稳定性高（MSI-H）的实体瘤患者，批准信息由该公司 11月10日发布。
该系统为基于聚合酶链式反应（PCR）的检测，评估实体瘤组织中的微卫星不稳定性状态，与之配套的药物为默克的抗 PD-1 疗法 Keytruda（帕博利珠单抗）。
Keytruda 的相关适应症为既往治疗后进展、无满意替代方案的不可切除或转移性 MSI-H 或错配修复缺陷实体瘤的成人与儿童患者，该适应症已于 2023 年 3 月获该局完全批准。
该系统此前已获该局批准用于识别可能受益于林奇综合征进一步检测的结直肠癌患者，也已是识别微卫星稳定型子宫内膜癌患者的已批准伴随诊断。公司称，本次批准系与默克合作支持，适用范围为美国及其领地。本条只报道批准与产品公布信息，不构成对任何个体的诊疗建议。
FDA Approves Promega OncoMate MSI Dx as a Companion Diagnostic for Keytruda: PCR-Based Test Evaluates Microsatellite Instability in Solid Tumors
Madison, Wisconsin — The U.S. Food and Drug Administration has approved Promega's OncoMate MSI Dx Analysis System as a companion diagnostic to identify patients with microsatellite instability-high (MSI-H) solid tumors who may be eligible for treatment with pembrolizumab (Keytruda), in an approval announced by the company on November 10.
The OncoMate MSI Dx Analysis System, developed by Promega Corporation in collaboration with Merck, is a polymerase chain reaction based assay that evaluates microsatellite instability status in solid tumor tissue.
Keytruda's related indication covers adult and pediatric patients with unresectable or metastatic MSI-H or mismatch repair-deficient solid tumors that have progressed following previous treatment and who have no satisfactory alternative options, which received full FDA approval in March 2023.
The system was previously cleared by the FDA to identify patients with colorectal cancer who may benefit from additional testing for Lynch syndrome, and is also an approved companion diagnostic for identifying patients with microsatellite-stable endometrial carcinoma. The company said the approval applies to the United States and its territories. This report covers the approval and published product information only and offers no individual treatment advice.
来源：Promega
发布：GSM·美国（发布链接）
图片来源：图：实验室人员将 PCR 混合液装入热循环仪（示意图）。作者与授权：26Isabella，CC BY 4.0，维基共享资源。 / Photo: Loading PCR mixture into a thermocycler (illustrative image). Wikimedia Commons (26Isabella, CC BY 4.0).
GSM Global · 本篇英文版 English edition of this story
