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康德生物成功通过ISO13485质量管理体系国际认证!
Sou Hu Cai Jing· 2026-02-24 02:41
近日,康德(深圳)生物技术股份有限公司正式通过ISO13485:2016医疗器械质量管理体系国际认证, 标志着康德生物在癌症检测体外诊断试剂研发、生产及服务全流程的质量管理能力达到国际标准,可持 续地为全球客户提供卓越可靠的产品与服务。 世界卫生组织提出,全球大约1/3的癌症完全可以预防,1/3的癌症可以通过早期发现得到根治,1/3的癌 症可以运用医疗措施延长生命、减轻痛苦。由此可见,癌症早筛早诊的重要性不言而喻。事实上,临床 上大部分患者确认患癌时多处于中晚期,错过了最佳治疗时间,而有效可靠的早期癌症检测体外诊断试 剂技术,正恰好能解决临床上部分癌症早期难发现的痛点。 康德(深圳)生物技术股份有限公司致力于研发生产高品质的癌症早筛早检体外诊断试剂产品,此次通 过ISO13485体系国际认证是康德(深圳)生物技术股份有限公司构建全面质量管理体系的重要里程碑。 不仅标志着公司质量管理水平迈上新台阶,更是对康德生物在研发、生产、销售等各个环节严格遵循国 际标准、确保产品安全与有效性的有力证明。同时,也见证了公司将高质量技术及产品赋能癌症精准诊 疗领域,为人类健康事业砥砺前行的使命和初心。 康德生物成功通过ISO1 ...
基准医疗UriFind®助力尿路上皮癌术前无创诊断及术后复发监测
智通财经网· 2025-08-18 09:19
Group 1 - The 2025 Guangdong Urology Academic Conference and Bladder Cancer Academic Conference was successfully held in Shenzhen from August 15-17, 2025, showcasing advancements in early screening for tumors [1] - The UriFind® product by Benchmark Medical was highlighted as an innovative leader in the field of early screening for urinary tract cancers, receiving significant attention from experts [1] - Clinical research involving 1,172 samples demonstrated that the UriFind® kit has a sensitivity of 89.74%, specificity of 92.46%, and accuracy of 91.47% for assisting in the diagnosis of urinary tract cancers [1] Group 2 - Benchmark Medical, a subsidiary of Kangsheng Global Medical Testing Group, focuses on utilizing tumor DNA methylation sequencing technology for early cancer diagnosis and screening [5] - The company has developed products targeting over 70% of high-incidence cancers, including lung, breast, digestive system, and urinary system cancers, covering the entire process from early screening to diagnosis and monitoring [5] - Benchmark Medical has also created a big data and artificial intelligence platform centered on early screening, diagnosis, and treatment of lung cancer [5]