SeaSun Biomaterials announced on the 2nd that the 'U-TOP MSI Detection Kit', a tumor screening diagnostic test product, has been recognized for indications for endometrial and ovarian cancer. This product obtained indications for colorectal cancer in August 2017 and gastric cancer in August 2018, and has proved the accuracy of diagnosis, clinical efficacy and safety in a total of four cancers with this license.

This achievement is a feat two years after the launch, and plans to add pancreatic cancer and biliary tract cancer next year. This test kit is a product that selects tumors by testing for microsatellite instability (MSI), a chromosomal abnormality that is specific to tumor cells. MSI has been found to be caused by the accumulation of mutations because the function of the gene replication error correcting gene (dMMR gene) is damaged, and the base made by mistake in the DNA replication process cannot be properly complemented.

MSI phenomenon is observed in various solid cancers such as lung cancer, bladder cancer, and prostate cancer, as well as colon cancer, gastric cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and biliary tract cancer, and is widely used as a diagnostic indicator.

In May 2017, the U.S. Food and Drug Administration (FDA) selected MSD's'Kitruda' (ingredient name pembrolizumab), an immunological anticancer drug, to MSI-H or dMMR biomarkers for high-frequency MSI (MSI-H) positive patients regardless of carcinoma. It has been approved for use in adult and pediatric patients with unresectable or metastasized solid cancer. It was the first case in which an indication of an anticancer drug was approved based on the expression of biomarkers regardless of the cancer site.

However, unlike the United States, Korea only approves the indications of Kitruda for carcinomas whose effectiveness has been proven through clinical trials for each carcinoma, so patients who benefit from this drug are limited. Accordingly, a petition is being made to the Health Insurance Review and Assessment Service, etc. so that Kitruda can be used as non-payment or salary at the level of detailed society for each cancer type.

An official from SeaSun Biomaterials said, "Even though Utop MSI Detection Kit is the only product approved for MSI testing in Korea, it cannot be applied to all cancers." "According to the domestic situation, carcinomas with high incidence or poor prognosis are given priority. I will expand it," he said.

SeaSun Biomaterials's MSI test method is contributing to the generalization of tests because it is simpler and more efficient than existing tests. In order to improve the shortcomings of the existing tests, which require complex and expensive separate analysis equipment and are inconsistent in reading, a process has been developed to enable tests with equipment already owned by many hospitals. This increases cost-effectiveness and allows MSI tests to be performed in small hospitals and laboratory rather than large hospitals.

The company exports MSI test kits to Greece, Italy and Costa Rica, and is receiving love calls from Thailand, Vietnam, Taiwan, and Bulgaria. This product was selected as the '2019 Next-Generation World-Class Product' by the Ministry of Trade, Industry and Energy in November of last year, and obtained CE certification, which is essential for European sales in September 2017.

CEO Park Hee-kyung said, "Since MSI-positive patients have proven therapeutic effects on some specific anti-cancer drugs, an MSI test must be performed prior to prescription in order to receive prescriptions." It is urgent to do so, so I will accelerate the expansion of indications.”