Rectal Cancer Early Screening Kit

2020-11-29

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On November 9, 2020, the National Medical Products Administration (NMPA) approved the registration application for the innovative three types of medical devices for the colorectal cancer early screening product of Nuohui Health, Chang Weiqing, and made it clear in the intended use that the product is suitable for ” Screening of 40-74-year-old people at high risk of colorectal cancer”. This is China’s first registration certificate for early cancer screening products approved by the National Medical Products Administration.

Early disease screening is an important direction in the field of medical development. For companies, early screening is a huge cake, with huge potential for development and profit; for patients, convenient and economical means can be used to screen diseases. Examination, early diagnosis and treatment, free from unnecessary burdens and pain, are also good news for health. The core of early screening products is to use simple methods to conduct non-invasive and extensive tests on people without obvious symptoms, and give the most accurate results to understand whether there is any hidden cancer risk.

In the 1970s, the United States began early diagnosis of colorectal cancer and formulated corresponding national prevention and control measures. Since the 1990s, its morbidity and mortality have declined significantly. In my country, according to Frost & Sullivan’s relevant report, the five-year survival rate for colorectal cancer patients in China is 56.9%. However, if the patient population is focused on early patients (patients whose cancer in situ has not yet spread and metastasized), the five-year survival rate can reach more than 90%; if the precancerous lesions can be detected and the lesions removed in time before the onset, five of the patients The annual survival rate is even closer to 100%.

Nuohui’s early diagnosis kit “Chang Weiqing” uses the PCR (fluorescent probe method) + colloidal gold technology route, and provides dual detection of DNA and FIT to detect stool samples that are closely related to the occurrence of bowel cancer. A variety of molecular indicators of DNA and protein. Judging from the results of clinical trials, “Chang Weiqing” is superior to the registered clinical trial results disclosed by Cologuard, which passed the US FDA as early as 2014 and was listed in the US in many indicators. For advanced adenoma, an important factor in assessing the risk of cancer, Chang Weiqing achieved 63.5%, while Cologuard only achieved 42.4%. At the same time, Chang Weiqing’s negative predictive value reached 99.6%, almost completely resolved Cologuard faced the false positive problem that year.

As Zhu Yeqing, co-founder and CEO of Nuohui Health, said, early screening may be the biggest “cake” in the entire field of cancer genetic testing. It is the top end of a “funnel” and the largest population market. It can avoid the pain of queuing in hospitals, registering, and drawing blood, doing gastrointestinal endoscopy and other “horrible” detection methods. It is our hope to obtain accurate physical information in a simple way and bring timely warnings of health risks. See the direction of medical development.

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