"Now, cancer patients are classified in this way, such as stomach cancer, liver cancer, and lung cancer, right? In the future, the day will come after biomarkers and say,'MSI-H (high) patients, MSI-L (low) patients'." Approval is a signal that will lead to tremendous changes in the field of diagnosis and treatment, as well as the traditional cancer classification system. We believe that diagnostic companies can play a major role.”

Park Hee-kyung, CEO of SeaSun Biomaterials, said, "I knew the trend of big change, but I didn't know that the US Food and Drug Administration (FDA) would approve biomarker anticancer drugs so quickly." It took years, but I'm glad the timing is right.”

On the 23rd of last month, SightBio received permission to manufacture in vitro diagnostic medical devices (Class 3) from the Ministry of Food and Drug Safety as a 'U-TOP MSI diagnostic kit' that can easily check microsatellite instability (MSI).
According to the'Comprehensive Examination System for Medical Device Permit and New Medical Technology Evaluation' introduced by the Ministry of Food and Drug Safety last year, it was quickly determined as a target for medical care benefits and the launch time was also accelerated.

MSI is the world's first biomarker that has been approved by the FDA so that'MSI-H' can be prescribed regardless of cancer type, regardless of cancer type.

MSI is a biomarker that can confirm whether a problem has occurred in the system that corrects DNA replication errors in the human body while the microsatellite, a region where DNA replication errors are frequent, is unstable. In addition to colon cancer, MSI also occurs in gastric cancer, endometrial cancer, pancreatic cancer, malignant melanoma, and lung cancer. This means that in the future, the range of potential patients who can use immunotherapy drugs such as Kitruda will be wider.

SeaSun Biomaterials is more pleased with the news of the first biomarker anticancer drug license in history. In order to select patients who are well-received by treatment, an MSI test is essential. SeaSun Biomaterials was also approved in Korea as a reagent that aids in the classification and diagnosis of colon cancer. Indications other than colorectal cancer will be sold as research reagents. This time, it was licensed as a tissue, but plans to expand it to liquid biopsy in the future.

SeaSun Biomaterials diagnostic reagent uses a technology that detects changes in the length of a DNA sequence as a change in temperature to determine MSI through real-time PCR. The real-time PCR diagnostic kit was the first in the world to improve accuracy while significantly reducing test cost and time.

CEO Park said, "The existing MSI test method required the use of expensive automatic base sequencing equipment and the procedure was complicated, but we improved it easily." "The sensitivity is high enough to detect." Higher sensitivity means that you are more likely to detect small variations. Currently, in order to target the European market, it is undergoing the European Quality Certification (CE) approval process, and plans to actively enter the companion diagnosis market related to biomarkers for immuno-anticancer drugs.