药物研发赋能解决方案
新药伴随诊断开发
新药伴随诊断开发
吉因加依托全链条解决方案，为药企提供覆盖“生物标志物发现>方法学开发>临床验证注册申报>商业化”的一站式伴随诊断服务。依托于现有的产品管线，我们深度参与多项伴随诊断合作项目，覆盖肺癌、肠癌、乳腺癌、胆管癌、黑色素瘤和前列腺癌等多个适应症。
合作案例
吉因加的伴随诊断（Pemigatinib）助力胆管癌精准诊断和靶向治疗，进行 FGFR2 基因融合患者人群筛查。2022 年 4 月获批，临床结果帮助其商业化上市。数据摘编自发表于《Cancer Medicine》期刊的 FIGHT-202 study。
Endpoints and assessments
Patients in the phase II study were prescreened for FGFR2 status by next-generation sequencing (NGS) with the Malignant Neoplasms Multi-Gene Analysis Kit (Suzhou Geneplus Biomedical Engineering Co., Suzhou, China) at the central laboratory on archival formalin-fixed and paraffin-embedded tumor samples or fresh tumor samples; FGFR2 status reports based on DNA sequencing performed within 2 years could also be used; a relative abundance of variant allele of >5.3% was used to define FGFR2 fusions or rearrangements (the lower boundary of frequency detected by FMI central laboratory in FIGHT-202 study).
Cancer Medicine. 2023;12:4137-4146.