国庆献礼！艾德生物HRD试剂盒被NMPA纳入创新医疗器械

1个月前 (03-31) 阅读数 17 #健康

文章标签癌症

近日，国家药监局（NMPA）医疗器械技术审评中心发布公示，艾德生物“人类同源重组修复缺陷检测试剂盒”（简称：“HRD试剂盒”）进入创新医疗器械特别审查程序，是我国目前唯一被纳入创新医疗器械的HRD试剂盒，也是艾德生物第三个获得NMPA“创新医疗器械”认定的产品。

HRD试剂盒是PARPi（靶向多聚ADP -核糖聚合酶抑制剂）新药治疗的伴随诊断产品。PARPi新药是一类用于以BRCA基因为核心的多基因多位点变异肿瘤的靶向药物，覆盖卵巢癌、前列腺癌、乳腺癌、胰腺癌等多癌种，使用前需要检测HRD状态。

此前，美国企业垄断了全球HRD检测市场。艾德生物采用自主专利的ADx-GSS^®智能算法研发出HRD试剂盒，打破美国企业的独家垄断。艾德生物HRD试剂盒在提高准确性的同时，涵盖了更适合我国患者的位点，全面满足国内外临床需求；该试剂盒同时运用了艾德生物自主创新的ADx-HANDLE^®专利建库技术，化繁为简、减少操作步骤，缩短患者等待检测结果的时间，解决了操作复杂、报告周期长等临床一大痛点。HRD试剂盒检测性能经过国内外权威第三方的严格评价^【1-13】，得到药企、国内外临床和病理专家的高度认可，已成为阿斯利康等药企PARPi新药的跨国多区域的“伴随诊断试剂”。

在PARPi新药伴随诊断领域，艾德生物从国内首个且目前唯一获批的BRCA基因检测试剂盒到“创新医疗器械”HRD试剂盒，全面覆盖了卵巢癌、前列腺癌、乳腺癌、胰腺癌等癌种，满足PARPi新药治疗的临床检测需求。

艾德生物作为“国家制造业单项冠军”、肿瘤精准诊断龙头上市企业，长期专注肿瘤精准诊断。十几年来，艾德生物以服务患者为目标，推动精准医疗行业发展，持续创新，研发合规、可靠的试剂盒，已获批上市29个III类体外诊断或伴随诊断试剂盒，全面覆盖各大癌种的精准检测，已经让数百万肿瘤患者从精准医疗中获益。HRD试剂盒获得“创新医疗器械”的认定，将加速HRD检测的院内合规应用，让更多肿瘤患者及时获得相关PARPi新药治疗，更进一步强化了艾德生物在肿瘤伴随诊断领域的领先优势。

参考文献

1.Weichert W, Lukashchuk N, Yarunin A, et al. An evaluation of the performance of molecular assays to identify homologous recombination deficiency-positive tumours in ovarian cancerInternational Journal of Gynecologic Cancer 2021;31:A366.

2.Yongpai Peng, Qingsheng Xie, Guocai Xu, and Bingzhong Zhang. The correlation of homologous recombination deficiency status with and Olaparib efficacy in Chinese ovarian cancer patients. Journal of Clinical Oncology 2022 40:16_suppl, e17556.

3.Wilko Weichert, et al. 572P High concordance of different molecular assays in the determination of HRD associated GIS in high grade epithelial ovarian cancer. ESMO, 2022.

4.Fumagalli C, Betella I, Ranghiero A, Guerini-Rocco E, Bonaldo G, Rappa A, Vacirca D, Colombo N, Barberis M. In-house testing for homologous recombination repair deficiency (HRD) testing in ovarian carcinoma: a feasibility study comparing AmoyDx HRD Focus panel with Myriad myChoiceCDx assay. Pathologica. 2022 Aug;114(4):288-294.

5.Scheiter, A, et al. Wnt/β-Catenin-Pathway Alterations and Homologous Recombination Deficiency in Cholangiocarcinoma Cell Lines and Clinical Samples: Towards Specific Vulnerabilities. J. Pers. Med. 2022, 12, 1270.

6.Yuan W, Ni J, Wen H, Shi W, Chen X, Huang H, Zhang X, Lu X, Zhu C, Dong H, Yang S, Wu X, Chen X. Genomic Scar Score: A robust model predicting homologous recombination deficiency based on genomic instability. BJOG. 2022 Nov;129 Suppl 2:14-22.

7.Hillary Stires, et al. Assessing Variability Across HRD Assays: Findings from the Friends’ HRD Harmonization Project. AMP Poster, 2022.

8.Magliacane G, Brunetto E, Calzavara S, et al. Locally Performed HRD Testing for Ovarian Cancer? Yes, We Can! Cancers (Basel). 2022 Dec 21;15(1):43.

9.Liu H, Zhang Z, Chen L, Pang J, Wu H, Liang Z. Next-Generation Sequencing Reveals a Very Low Prevalence of Deleterious Mutations of Homologous Recombination Repair Genes and Homologous Recombination Deficiency in Ovarian Clear Cell Carcinoma. Front Oncol. 2022 Jan 12;11:798173.

10.Doig KD, Fellowes AP, Fox SB. Homologous Recombination Repair Deficiency: An Overview for Pathologists. Mod Pathol. 2023 Mar;36(3):100049.

11.Dana Ruminski Lowe, er al. Multi-site evaluation of FFPE homologous recombination deficiency reference materials.Cancer Res (2023) 83 (7_Supplement): 6110.

12.Kekeeva T, et al. HRD Testing of Ovarian Cancer in Routine Practice: What Are We Dealing With? Int J Mol Sci. 2023 Jun 22;24(13):10497.

13.Feng C, Zhang Y, Wu F, Li J, Liu M, Lv W, Li C, Wang W, Tan Q, Xue X, Ma X, Zhang S. Relationship between homologous recombination deficiency and clinical features of breast cancer based on genomic scar score. Breast. 2023 Jun;69:392-400.

版权声明

本文仅作者转发或者创作，不代表旺旺头条立场。
如有侵权请联系站长删除

上一篇：达沃斯2025｜世界经济论坛年会传递“中国声音” 下一篇：核桃少年走进字节！“星耀计划”开启名企AI探索之旅~

发表评论:取消回复

◎欢迎参与讨论，请在这里发表您的看法、交流您的观点。