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HPV尿液检测离应用还有多远
第一财经· 2025-05-20 08:57
2025.05. 20 相达生物科技董事长及首席执行官招彦焘告诉第一财经记者,大多数人更愿意选择尿液检测。"调查 显示80%的人偏好尿液方式。"他说道,"这种非侵入式的检测方式不仅适用于女性,也同样适用于 男性HPV检测。" 据相达生物此前公布的数据,在与北京大学深圳医院合作的最新临床研究中,该尿液检测对 CIN2+病变(包括子宫颈癌前病变及子宫颈癌)的灵敏度达93.4%,并且在HPV 16型及18型的检 测中,与医生采集样本的黄金标准检测(罗氏Cobas 4800)相比,达到超过97%的一致性。 目前,包括诺辉健康在内的多家检测公司也都在开发相关产品,但国内还没有任何HPV尿检产品或 居家检测产品获批。招彦焘对第一财经记者表示,目前相达生物的检测产品在国内仍处于临床注册阶 段,即将启动大规模临床试验。 "我们会在美国、中国和中国香港三地同步推动临床,并可通过LDT模式商业化。"招彦焘说,他预 计产品从临床走向最终获批上市可能需要一年多时间。 本文字数:1210,阅读时长大约2分钟 作者 | 第一财经 钱童心 5月20日,相达生物科技宣布完成3400万美元的A轮融资。最新融资由亚洲最大独立资产管理公司 之一的 ...
相达生物获3400万美元融资,开发宫颈癌早筛新方式,HPV尿液检测离应用还有多远
Di Yi Cai Jing· 2025-05-20 05:18
Group 1 - Several diagnostic companies are developing HPV testing products, but no HPV urine test or home testing product has been approved in China [1] - Xiangda Biotechnology announced the completion of a $34 million Series A financing, marking the largest Series A financing in the Asian diagnostic technology sector since 2019 [1] - The company has developed the world's first HPV urine genetic testing, providing new possibilities for early screening of diseases like cervical cancer [1] Group 2 - Teal Health received FDA approval for the first home cervical cancer screening test, which allows for remote medical consultations and self-sampling at home [1] - The self-sampling method used by Teal Health is invasive, while urine testing is non-invasive, which is preferred by 80% of people according to surveys [2] - Xiangda's urine test has shown a sensitivity of 93.4% for CIN2+ lesions and over 97% consistency with the gold standard test [2] Group 3 - The cost of Xiangda's urine test is currently comparable to the gold standard testing method, with plans to reduce costs to match domestic vaginal swab testing within a year [3] - There is a significant gap in early cervical cancer screening for women, with targets set by the National Health Commission to reach a screening rate of 50% by 2025 and 70% by 2030 [3] - The introduction of urine testing products could meet the unmet demand in the cervical cancer early screening market and open up the male HPV testing market [3]