(Health Times reporter Zhao Mengmeng) On January 7, Nuohui Health's stock price once soared to 28.2 Hong Kong dollars, compared with the previous daily close of 19.3 Hong Kong dollars / share, up nearly 47%, as of the close, there was a decline, closed at 22.8 Hong Kong dollars / share, up more than 18%. In 2020, Nuohui Health debuted in the cancer early screening market with the colorectal cancer early screening product "Chang Weiqing", which won the "first certificate" of China's early cancer screening. After 14 months, it once again brushed up on the presence with the first Helicobacter pylori test product suitable for "consumer self-testing" in China.
On January 6, Nuohui Health announced that its Helicobacter pylori detection product, The Phantom Tube, has been approved by the State Drug Administration for the registration of class III medical devices. This is the first Helicobacter pylori testing product approved by the State Food and Drug Administration for "consumer self-testing", and it is also the second product of Nohui Health to obtain a class III medical device registration certificate after the colorectal cancer early screening product.
The approval of the Yuyu tube also means that Nuohui Health Cancer Early Screening Home Detection "Next City", which is its third commercial product after Chang Weiqing and Pu Pu Tube. According to the semi-annual report of Nuohui Health, in the first half of 2021, Nuohui Health relied on Chang Weiqing and Pu Pu Pipe to achieve operating income of 43.9 million yuan, an increase of 317% year-on-year. With the listing of the ghost tube and the volume of previous products, the performance of Nuohui Health is expected to continue to improve.
On November 26, 2021, Academician Li Zhaoshen of the Naval Military Medical University led the publication of the "Consensus Report on the Prevention and Control and Management of Helicobacter pylori Infection (Hp) in Chinese Households (2021 Edition)", which introduced a new strategy of Hp management: "Prevention and control of Hp infection by family" to prevent the spread of Hp family and related diseases.
According to the WeChat of the official website of Shanghai Changhai Hospital, about 40%-60% of the population in China is infected with Hp. "There are many risk factors for gastric cancer, such as genetic factors, environmental and dietary factors, and Helicobacter pylori infection, and current research shows that Hp infection is the most important controllable risk factor for preventing gastric cancer." Professor Du Yiqi, deputy director of the Department of Gastroenterology of Changhai Hospital of naval military medical university, said.
Previously, the "gold standard" for Helicobacter pylori testing was the carbon-13/carbon-14 urea breath test. Subjects need to go to a medical institution, swallow carbon-13/carbon-14 urea capsules for 15 minutes, and breathe a breath after testing.
How to measure Helicobacter pylori at home?
Zhu Yeqing, executive director and CEO of Nuohui Health, said that the biggest breakthrough of the ghost tube is to change the scene of Helicobacter pylori detection, in the past, everyone needed to go to the hospital, physical examination institutions, etc., to accept the test of professional medical staff, and now the ghost tube can be tested at home, no need to take medication before testing, no need to fast when testing, no special requirements for sample collection.
The humorus duct uses a double antibody sandwich method to detect the presence of Helicobacter pylori antigen in stool samples. After the subject has sampled, insert the sample stick back into the reagent tube, shake well for 10 seconds, and read the results 10 minutes after pressing the lid. The integrated design of sampling and testing "pregnancy test stick" is painless and non-invasive.
How is the accuracy of the people's own home self-test and the ratio of medical institutions?
It is reported that Nuohui Health in The Shaw Run Hospital affiliated to Zhejiang University School of Medicine, Zhejiang Provincial People's Hospital and Peking University Shougang Hospital, included a total of 1,644 effective subjects with suspected Helicobacter pylori infection, with a sensitivity of 96. 5%, specificity of 99. 1%, the subject's self-test results were compared with the professional test results, and the compliance rate reached 100%.
"According to the requirements of the State Food and Drug Administration, clinical studies of consumer self-testing should fully verify that ordinary people without medical foundation can also accurately complete self-test interpretation." The experimental design fully considers the educational level of the enrolled population to verify whether the operation steps of the product and the interpretation of the results are easy to understand and convenient. Zhu Yeqing said.
"This trial has fully achieved the clinical research goal, and the participants who have a positive test result on the ghost tube are very likely to be infected, and it is recommended to seek medical treatment in time to determine the next step of treatment." Professor Pan Wensheng, a researcher of the Yuyu Tube Project and director of the Department of Gastroenterology of Zhejiang Provincial People's Hospital, said, "We hope that the home testing of 'consumer self-testing' can enhance the public's awareness of autonomous health management, do not seek medical treatment when you are sick, and you can also change passive to active in seeing a doctor."
When can I buy a ghost tube? How much?
Zhu Yeqing exclusively responded to Health Times that the product is expected to complete the production license and related procedures in about a week, and it is expected that the 18th will be launched on all channels such as JD.com and Tmall, and the pricing will be announced on the day of listing.
"Nuohui Health has been focusing on early home screening of high-incidence cancers, hoping to help the people achieve early screening at home, and use convenient and accurate methods to improve compliance with early cancer screening," Zhu Yeqing revealed, in addition, the company has three pipelines of products under development for liver cancer, cervical cancer and nasopharyngeal cancer screening.
On January 6, Sun Yat-sen University, the Affiliated Cancer Hospital of Sun Yat-sen University and Nuohui Health jointly held a patent transfer and cooperation signing ceremony for nasopharyngeal cancer screening, which included two patents related to nasopharyngeal cancer screening, including "a diagnostic marker of nasopharyngeal cancer" and "a nasopharyngeal brush". On this basis, the three parties will jointly develop nasopharyngeal cancer screening products, and plan to carry out a series of clinical studies after product finalization, declare to the State Food and Drug Administration to start prospective large-scale registered clinical trials, declare the first domestic NASOPHARyngeal cancer screening registration certificate, and expect to start registered clinical trials in 2023 and are expected to be approved for listing in 2025.
Editor-in-charge: Zhao Mengmeng
Proofreader: Qiu Yue
![Two patents related to nasopharyngeal cancer screening have been transferred, and the early diagnosis rate of nasopharyngeal cancer is expected to increase[fig]](data:image/gif;base64,R0lGODlhAQABAIAAAP///wAAACwAAAAAAQABAAACAkQBADs=)