U-TOP HPy-ClaR Detection Kit has been approved for manufacturing in vitro diagnostic medical devices (Class 3) from the Ministry of Food and Drug Safety. Please refer to the text for details.

"From Helicobacter detection to antibiotic resistance can be confirmed in 2 hours"

In vitro diagnostic medical for 'U-TOP HPy-ClaR Detection Kit' that can simultaneously detect Helicobacter pylori, which is known as the first-class causative factor of gastric cancer from the Ministry of Food and Drug Safety, and the presence or absence of the antibiotic clarithromycin resistance. It was announced on the 20th that it had obtained the manufacturing license for the device (class 3).

'U-TOP HPy-ClaR Detection kit' is a product that can simultaneously detect Helicobacter bacteria and whether the antibiotic clarithromycin resistance has been separately performed. On the other hand, the product can confirm both test results within 2 hours.

Helicobacter bacteria, which are defined as carcinogens by the World Health Organization, are known to inhabit the gastric mucosa and cause chronic gastric abscess, gastric ulcers, and gastric cancer. In particular, the infection rate and recurrence rate are high in Asians including Koreans. In particular, in the case of young gastric cancer patients, the infection rate of Helicobacter bacteria is over 90%, which is far higher than that of the same age group, and the correlation between Helicobacter bacteria and gastric cancer is reported to be high.

In the Helicobacter bacteria treatment, in general, if the bacteria do not disappear after the first antibiotic treatment, the second treatment is performed by changing the combination of drugs. At this time, the antibiotic resistance test is performed to determine whether the antibiotic is suitable. Clarithromycin is mainly used as a primary antibiotic of Helicobacter bacteria, but it is a problem because resistance is steadily increasing.

While conventional tests require cultivation of viable bacteria for a long time, the 'U-TOP HPy-ClaR Detection kit' can test even in inactivated Helicobacter bacteria and can check not only the presence of the bacteria but also the resistance at the same time. At the same time, it is explained that it is possible to apply suitable therapeutic agents.

SeaSun Biomaterials entered the cancer diagnosis market in earnest last year, starting with the approval and launch of the 'U-TOP MSI Detection kit', a product that can aid in the classification and diagnosis of colon cancer, from the Ministry of Food and Drug Safety. Currently, the 'U-TOP MSI Detection kit' has been clinically completed to expand indications for gastric cancer following colon cancer. A company official said, "As it is reported that the infection rate of Helicobacter pylori is high in MSI-positive gastric cancer, the use of both products is expected to increase as a predictive test for gastric cancer."