Can early screening for cervical cancer be done with urine? Related products are expected to be launched in 2027
2023-09-05
Can contact urine for early screening of cervical cancer? The reporter recently learned that the largest prospective registered clinical trial for early screening of cancer in China, which included a total of 16000 subjects, is currently underway, and related products are expected to be launched in 2027. Sampling is more convenient and private, and screening is more proactive. Cervical cancer is the only malignant tumor with a clear etiology, and it is also the most likely high-risk cancer to achieve eradication. In addition to HPV vaccination, early screening for cervical cancer is also an irreplaceable means of prevention and control. The current screening rate for cervical cancer in China is only 40%, and there is still a significant gap between reaching the screening standard of 70% by 2030. Currently, cervical cancer screening is conducted by doctors in hospitals for invasive cervical sampling. Statistics show that 80% of Chinese women are unwilling to accept such sampling for various reasons, which to some extent affects their enthusiasm for regular cervical cancer screening. Is there a way to make sampling more convenient and private, so that more women are willing to undergo cervical cancer screening? Recently, Hangzhou Nuohui Health Technology Co., Ltd. (hereinafter referred to as "Nuohui") officially announced the baseline data of the registered clinical trial of its cervical cancer HPV home sampling screening product Gongzhengqing. It is understood that Nuohui launched the development of related products in 2017 to explore a painless and non-invasive HPV screening method for cervical cancer. Female friends take 20 to 30 milliliters of urine from their own homes, and after sampling, the samples are shipped to the relevant laboratory. The test report can be obtained online within 5 working days. A positive test result indicates that the subject has a high risk of cervical cancer and precancerous lesions, and further examination is necessary. A negative test result indicates that the subject has a low risk of cervical cancer and precancerous lesions, and regular screening according to routine procedures is sufficient in the future. Is this reliable testing method for large-scale clinical trials expected to be launched in 2027? It is understood that the product will officially launch a prospective large-scale multicenter registered clinical trial in mid-2022. This experiment is divided into two stages. The first stage completes the baseline study and outpatient accuracy study for the screening population, and the second stage conducts a three-year follow-up study for the screening population. As of June 2023, the baseline enrollment of the screening population has been completed, including a total of 16744 subjects who met the inclusion criteria and were compared with cervical swab samples collected by physicians for HPV testing. According to public information from the National Drug Administration, this is the largest prospective registered clinical trial for early screening of cancer in China to date. The current experimental data shows that the overall positive rate of HPV in the subjects is about 10%, and the total coincidence rate between the baseline clinical data of Gong Zheng Qing and cervical samples is 97.42%, with a positive coincidence rate of over 90% for HPV16/18. The data shows that there is high consistency between urine self sampling and medical cervical HPV testing. It is reported that the planned development cycle of this product is up to 10 years and is expected to be launched in 2027. Reporter: Chen Hui (full media reporter for Yangcheng Evening News) (Xinhua News Agency)
Edit:GuoGuo Responsible editor:FangZhiYou
Source:ycwb.com
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