On March 24, 2025, Luye Diagnostics announced that "You Shu Xin", a Helicobacter pylori nucleic acid test kit independently developed by its subsidiary Cellrun (Shanghai) Medical Technology Co., Ltd., has officially obtained the marketing approval from the National Medical Products Administration. Based on molecular diagnostic technology, this product is used for the auxiliary diagnosis of Helicobacter pylori (Hp) infection through fecal samples. It is suitable for patients with symptoms of gastric diseases such as gastritis, peptic ulcer, dyspepsia or those suspected of having such diseases.
Hp is a pathogenic bacterium associated with a variety of major chronic diseases; and is infectious. Its infection can lead to various gastric diseases such as gastric ulcer, atrophic gastritis, mucosa-associated lymphoid tissue lymphoma of the stomach, etc. Hp is also the only currently identified bacterial pathogen closely related to the occurrence of gastric cancer and has been classified as a Group 1 carcinogen by the International Agency for Research on Cancer (IARC) of the World Health Organization.
"You Shu Xin" adopts the fluorescence quantitative PCR technology. It detects the Hp nucleic acid fragment through specific primer probes and sets an internal quality control at the same time to double-guarantee the accuracy of the detection. Verified by multi-center clinical trials, the detection accuracy rate exceeds 98%. "You Shu Xin" uses non-invasive fecal sample testing, does not require fasting, and the process is safe and convenient. It is especially suitable for special groups such as diabetic patients, patients with renal insufficiency, pregnant women, adolescents and children, those with cognitive impairment or who cannot cooperate, as well as those with pulmonary diseases such as chronic obstructive pulmonary disease. Compared with traditional Helicobacter pylori detection methods, "You Shu Xin" also has multiple advantages:
Compared with the Urea Breath Test (UBT): There are no restrictions on the applicable population, avoiding the use limitations of 13C/14C isotopes and reducing false negatives and false positives.
Compared with serum antibody testing: It can distinguish between current infection and past infection.
Compared with fecal antigen testing: The detection accuracy rate is significantly improved.
Compared with gastroscope sampling: It is non-invasive and can be sampled at home.
Regarding the Hp drug resistance problem that is widely concerned in clinical practice, the Hp drug resistance gene test kit simultaneously developed by Luye Diagnostics has entered the registration and application stage. This product can quickly detect the drug resistance gene mutations of commonly used antibiotics in Hp treatment, providing a molecular basis for personalized medication and improving the Hp eradication rate.
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