Novogene Health Announces Results of China's First Prospective, Large-Scale, Multicenter Registered Clinical Trial for Cancer Early Screening

On September 25, New Horizon Health officially released key data results from China’s first prospective, large-scale, multicenter registration clinical trial for early cancer screening (Clear-C) at the 2020 CSCO Academic Annual Conference. Supervised and guided by the National Medical Products Administration, the “Clear-C” trial employed Colotect®, New Horizon Health’s early colorectal cancer screening technology. The CSCO Academic Annual Conference is a prestigious oncology academic event organized by the Chinese Society of Clinical Oncology (CSCO), focusing on the most cutting-edge innovations and practices in clinical oncology.

The “Clear-C” (Colorectal Cancer Early Screening in China) registered clinical trial was led by the Second Affiliated Hospital of Zhejiang University School of Medicine, in collaboration with seven other large tertiary A hospitals: Jiangsu Province People’s Hospital, Fudan University Shanghai Cancer Center, West China Hospital of Sichuan University, Tianjin Medical University General Hospital, Shanxi Provincial People’s Hospital, Hubei Cancer Hospital, and the First Affiliated Hospital of Zhengzhou University. Spanning 16 months, the trial aimed to evaluate the clinical value of innovative early screening technologies for colorectal cancer in reducing the incidence and mortality of colon cancer in China. Officially launched in September 2018, the trial accumulated nearly 6,000 enrolled cases, with 4,758 cases actually included in the statistical analysis. All clinical data have now been formally submitted to the National Medical Products Administration.

“New Horizon Health has witnessed the pioneering efforts and development in the field of home-based testing for early cancer screening in China. Like the millions of frontline clinical doctors across the country, we deeply understand that a rigorous and responsible attitude, coupled with professional and precise technology, forms the unshakable foundation for the research, development, and innovation of medical products,” stated Zhu Yeqing, Co-founder and CEO of New Horizon Health. “Clear-C represents the most significant clinical trial investment by New Horizon Health over the past seven years. We are fully confident in launching it at CSCO, China’s most prestigious oncology academic forum, and look forward to collaborating with industry experts to explore precise screening methods aimed at reducing the incidence and mortality rates of colorectal cancer in China.”

Professor Ding Kefeng, Principal Investigator of the “Clear-C” clinical study, Vice President of the Second Affiliated Hospital of Zhejiang University School of Medicine, and Chief Scientist of the National 13th Five-Year Major Special Project on Colorectal Cancer Disease-Specific Cohort Study, announced the key data results of the “Clear-C” trial on behalf of the study group. “‘Clear-C’ is China’s first prospective, large-scale, multicenter registered clinical trial for early cancer screening. This trial has fully achieved its clinical research objectives and holds significant clinical implications for the early screening of colorectal cancer,” stated Professor Ding. He further highlighted three distinctive features of the trial: first, it represents the first prospective registered clinical trial on early colorectal cancer screening conducted in China; second, it enrolled a large sample size; and third, it yielded excellent results. All enrolled participants were required to undergo colonoscopy concurrently with the Colotect® test, and the screening results of Colotect® were validated against the gold standard of colonoscopy and pathological examination. Furthermore, this large-scale prospective trial design closely mirrors real-world screening scenarios, facilitating early screening to prevent the occurrence of colorectal cancer, enabling early diagnosis, and improving the therapeutic outcomes of early-stage colorectal cancer. The trial demonstrates clear clinical significance, with the potential to substantially enhance early treatment efficacy and prevent the development of colorectal cancer.

 ColoClear® demonstrates significantly higher sensitivity in detecting colorectal cancer than traditional fecal immunochemical testing (FIT).

During the “Clear-C” trial, Changweiqing® was compared head-to-head with FIT (fecal immunochemical test), a traditional clinical screening method for colorectal cancer. A head-to-head comparison refers to a parallel controlled trial conducted simultaneously within the same study design to evaluate the clinical screening performance of Changweiqing® and FIT, rather than relying on historical controls or results from separate studies by different investigators, thereby providing more compelling evidence.

The data results indicate that the sensitivity of Changweiqing® for detecting colorectal cancer is 95.5%, while the sensitivity of FIT is 69.8%. The sensitivity of Changweiqing® for detecting colorectal cancer is significantly higher than that of FIT, enabling earlier and more accurate alerts to clinicians regarding the risk of colorectal cancer in screened individuals, and improving patient compliance with follow-up colonoscopy confirmation.

Professor Ding Kefeng stated that colorectal cancer screening in China currently relies primarily on questionnaires, fecal occult blood tests (FOBT), and colonoscopy. Only 40% of high-risk individuals are willing to undergo colonoscopy, indicating poor compliance. As a refined screening tool, Changweiqing® boasts a sensitivity of up to 95.5% for colorectal cancer. When combined with initial screening via questionnaires and FOBT, it effectively enriches the high-risk population, significantly improving the detection rate of colonoscopy.

ColoClear® Achieves a Major Breakthrough in Domestic Clinical Performance for Advanced Adenoma Screening

The data from the “Clear-C” trial demonstrated that Colotect® has a detection sensitivity of 63.5% for advanced adenomas. Compared with FIT, which has a detection sensitivity of 30.9%, Colotect® more than doubles the sensitivity for detecting advanced adenomas. This figure is also significantly superior to the 42.4% detection sensitivity for advanced adenomas reported for Cologuard®, the only colorectal cancer early screening product currently approved by the U.S. FDA (U.S. Food and Drug Administration).

Professor Cai Sanjun, one of the investigators of the “Clear-C” study, Chief Expert of the Multidisciplinary Team for Colorectal Cancer at Fudan University Shanghai Cancer Center, and Director of the Colorectal Cancer Diagnosis and Treatment Center at Fudan University, stated that early detection and intervention for advanced adenomas can achieve the most ideal clinical outcomes in colorectal cancer prevention and control, and are key to reducing colorectal cancer incidence through screening. “Clear-C” demonstrated the ability of Colotect® to effectively detect advanced adenomas, representing a significant breakthrough in clinical diagnostic performance. Based on the results of the “Clear-C” trial, Colotect® is currently the most accurate molecular screening test for colorectal cancer worldwide.

In the “Clear-C” trial, Colotect® demonstrated exceptional performance in Negative Predictive Value (NPV) for colorectal cancer, reaching 99.6%. NPV refers to the proportion of individuals truly free of the disease among those identified as healthy by the diagnostic method under evaluation, and it is one of the internationally recognized authoritative metrics for assessing early screening products. An NPV of 99.6% indicates that Colotect® has an extremely low likelihood of false negatives, providing greater reassurance to individuals with negative test results.

“Professor Gu Yanhong, Deputy Director of the Department of Oncology at Jiangsu Province Hospital and one of the investigators of the ‘Clear-C’ study, stated that in clinical practice, screening and health check-ups serve similar purposes. Their core function is to help individuals rule out health risks, maximize the reliability of negative test results, and encourage those with positive results to seek medical attention at a hospital. The ‘Clear-C’ study adopted a prospective experimental design, yielding data with significantly higher reliability than retrospective studies, thereby providing greater credibility for tested individuals.”

Multi-Target Stool FIT-DNA Combined Detection Technology—ColoClear® is independently developed by New Horizon Health. It is currently the most accurate molecular screening test for colorectal cancer worldwide, designed specifically for genetic loci in the Chinese population and holding multiple national patents. In May 2018, ColoClear® entered the Green Channel for Innovative Medical Devices and subsequently launched China’s first prospective, large-scale, multicenter registration clinical study for early cancer screening under the guidance and supervision of the National Medical Products Administration (NMPA).

New Horizon Health, founded in 2013, is a pioneer in early cancer screening and home-based testing in China. As the first biotech company in China dedicated to early cancer screening, New Horizon Health pioneered the service concept of “home-based early screening for high-incidence cancers.” Its independently developed multi-target stool FIT-DNA combined detection technology—Changweiqing®—is currently the most accurate molecular test for colorectal cancer screening worldwide.

The company has established third-party medical testing laboratories with a total area of 20,000 square meters in Beijing, Hangzhou, and Guangzhou. Its product pipeline covers colorectal cancer, cervical cancer, gastric cancer, lung cancer, and other areas. Targeting cancer types with high incidence among the Chinese population, New Horizon Health is committed to providing the most effective early screening solutions, enabling users to access accurate, efficient, and convenient cancer early screening services from home, thereby offering hundreds of millions of Chinese families a new choice for health consumption.