China Securities Network News (Reporter Fu Suying) On January 6, Nuohui Health announced that its Helicobacter pylori testing product Youyoutube has received approval from the State Drug Administration for registration of three types of medical devices. This is the first Helicobacter pylori testing product approved by the State Drug Administration for “consumer self-testing” in China.
Products previously approved for Helicobacter pylori testing were limited to testing by medical professionals at medical institutions. For the first time, the Youyou Tube realized the “pregnancy test stick” integrated design for sampling and testing. The user is easy to operate, painless and non-invasive, there is no need to take medication before the test, no need to be hungry during the test, and there are no special requirements for sample collection. After sampling, the results can be read for 10 minutes after pressing the tube cap. It has been verified by registered clinical trials supervised by the State Drug Administration, which fully meets the requirements of accuracy, safety and convenience required for “consumer self-testing”.
The registered product of Youyou Tube is called Helicobacter pylori antigen detection reagent (latex method). An advanced double antibody sandwich method is used to test whether Helicobacter pylori antigen is present in stool samples. Helicobacter pylori settles on the surface of gastric mucosal epithelial cells in the human body and can fall off as gastric mucosal epithelial cells renew. Therefore, fecal antigen testing is currently one of the most direct and effective testing methods, and has been widely recommended by domestic and international medical guidelines and consensus.
“The normalization of the COVID-19 fight will accelerate the implementation of health management at home. On December 28, 2021, ten ministries and commissions included POCT products in the “14th Five-Year Plan” for the development of the medical equipment industry in the national key development plan. This is the first time that the State Drug Administration has approved 'consumer self-test' products, which is an important benefit for the development of the home testing industry.” Zhu Yeqing, Executive Director and CEO of Nuohui Health, said, “Novartis Health will insist on transforming R&D results into a more convenient user experience, complete reliable clinical trials to achieve product compliance and approval, and continue to innovate user services for consumer medical products. We hope to help more asymptomatic people and high-risk people get screened early and seek medical treatment early. When problems are discovered, they are 'alarmed' rather than 'unable to regret it'.”
Helicobacter pylori infection is an internationally recognized class I carcinogen of gastric cancer. The infection rate of Helicobacter pylori in China is as high as 40%-60%. It is mainly transmitted through the oral-oral route. It is highly contagious and rarely cured without treatment. Almost all infected people can cause gastritis, peptic ulcers occur in about 15-20%, and gastric malignancies occur in about 1%. According to the “5th National Helicobacter Pylori Infection Treatment Consensus Report”, whether asymptomatic or complicated, Helicobacter pylori gastritis is an infectious disease, and elimination treatment targets can be extended to asymptomatic people.
According to reports, using the exhalation method as the gold standard, a total of 1,644 effective subjects suspected of being infected with Helicobacter pylori were included in the three tertiary clinical hospitals of the Shaw Hospital affiliated to Zhejiang University School of Medicine, Zhejiang Provincial People's Hospital, and Peking University Shougang Hospital. The sensitivity reached 96.5%, and the specificity reached 99.1%. The test results of the subjects were compared with the test results of professionals, and the compliance rate reached 100%.