Proven association with MSI-related gastric cancer in 10-15% of gastric cancer patients

SeaSun Biomaterials (CEO Park Hee-kyung) announced on the 27th that the U-TOP MSI Detection kit can be used for gastric cancer following colon cancer. This kit was recently approved by the Ministry of Food and Drug Safety and the Health Insurance Review and Assessment Service as a gastric cancer classification diagnosis product and a decision to expand its use and medical treatment benefits.

The approval of this permission was decided more quickly than before by following two procedures at the same time, thanks to the implementation of the “Integrated Examination System for Medical Device Permit and New Medical Technology Evaluation”. The U-TOP MSI diagnostic kit is the only licensed test product in Korea that determines microsatellite instability (MSI), and it is the only product in the world that uses real time PCR. It is being evaluated. Existing tests using large-scale automated DNA analysis equipment require a specialized genetic analysis agency to check the results after a few weeks, but Utop MSI diagnostic kits are relatively inexpensive and use universal real-time PCR. You can directly analyze and check the test results within 4 hours.

The microsatellite is part of the genome (DNA) in which short nucleotide sequences consisting of 1 to 6 base pairs are repeated, and accounts for about 5% of the total DNA. When DNA is duplicated, errors frequently occur in this section, but if there is no protein to repair the mismatch error or if there is a problem with the function to correct the replication error, the number of repetitions of the short nucleotide sequence may be less or more than normal, resulting in mutation. .

Currently, the MSI test is mainly used for secondary diagnosis of nasal polyposis colon cancer. However, in addition to colon cancer, MSI has been confirmed in stomach cancer, endometrial cancer, pancreatic cancer, malignant melanoma, and lung cancer, and recently, the US Food and Drug Administration (FDA) used Merck's (MSD) immune anticancer drug'Kitruda' (ingredient name pembrolizumab). With permission to prescribe for all cancer patients with advanced MSI (MSI-H), the scope of use of the MSI test for screening treatments is expected to expand further.

An official from SeaSun Biomaterials said, “It is known that MSI is present in 15-30% of gastric cancer patients and 75% of cases with hereditary nasal polyposis colon cancer and endometrial cancer, and this Utop MSI diagnostic kit has additional approval for gastric cancer. Through this, it is possible to confirm the presence or absence of MSI-H, which is one of the essential requirements for the prescription of targeted treatments administered to gastric cancer patients.”

Currently, in Korea, in September of last year, MSD's Kitruda obtained approval (off-label, not paid in full) to prescribe it as a third-line treatment for colorectal cancer (rectal cancer, colon cancer) patients with MSI-H. Other cancers such as gastric cancer can be prescribed non-payment as a second or higher treatment.

CEO Park Hee-kyung said, “In these days, where personalized medicine and precision medicine are emphasized, the trend in which doctors prescribe optimal anticancer drugs according to genotype will accelerate.” He said, “I am happy to be able to help with treatment by developing essential genome testing products.” said.