MSI Detection kit CE certified

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MSI Detection kit CE certified

운영자
Date 2021.01.26
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SeaSun Biomaterials, MSI kit CE certified. Targeting the market for immuno-cancer drug markers

The first MSI in vitro diagnostic kit to pay attention to expandability.. In Korea, grade 3 approved last month

SeaSun Biomaterials, a genome analysis and diagnostic kit specialist in Daejeon, is taking the first step toward entering Europe with the 'U-TOP MSI Detection Kit' that diagnoses microsatellite instability (MSI). It received the European Quality Certification (CE), which is another achievement following the approval of a medical device for in vitro diagnosis (Class 3) by the Ministry of Food and Drug Safety in Korea last month. In particular, the U.S. Food and Drug Administration (FDA) has recently approved an immune anticancer drug 'Kitruda' according to the MSI level (biomarker) regardless of carcinoma. As a diagnostic kit, the future market prospect is also positive.

On the 25th, SeaSun Biomaterials announced that it has received the European CE of the 'U-TOP MSI Detection Kit'. 'U-TOP MSI Detection Kit' is the world's first diagnostic kit to quickly and easily diagnose and analyze MSI using Realtime-PCR. It performs conventional tests that require cumbersome analysis procedures using expensive analysis equipment. It is a replacement product.

SeaSun Biomaterials completed the clinical trial at Severance Hospital in the first half of this year, and received approval from the Ministry of Food and Drug Safety last month by proceeding with the approval process in the form of in vitro diagnostic medical device (class 3) approval and new medical technology evaluation integration. In Korea, it is already sold under health insurance as a reagent that aids in the classification and diagnosis of colon cancer.

Microsatellite refers to a region in which short nucleotide sequences (less than 10) are repeated several times among all human genes. Mistakes frequently occur in this section when replicating DNA, 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 phenomenon that the number of repetitions of the short sequence is more or less than normal is caused by microsatellite instability. It is called (MSI). MSI appears not only in colon cancer, but also in gastric cancer, endometrial cancer, pancreatic cancer, breast cancer, and thyroid cancer.

However, microsatellite diagnosis was an area that was difficult to commercialize because it was necessary to examine changes in gene length and analyze five or more genes simultaneously. In the case of the existing diagnosis, gene amplification through polymerase chain reaction is then examined by fragment analysis. In most cases, it is difficult to analyze directly at the hospital due to expensive analysis equipment and cumbersome analysis procedures, so in most cases, it is left to an external institution.

SeaSun Biomaterials has developed a diagnostic reagent that determines MSI instability through real-time PCR using a technology that detects changes in the length of a DNA sequence as a change in temperature. In particular, this product is a diagnostic product that can distinguish microsatellite stability (MSS), microsatellite instability-high (MSI-H), microsatellite instability-low (MSS-H), and microsatellite instability-low (MSS), which are detailed states of microsatellite. to be. Among the microsatellite markers, five markers of the Quasi guideline, which are highly sensitive, can be used to derive the same results as the existing MSI fragment analysis.

CEO Park Hee-kyung said, “The U-TOP MSI Detection Kit is the first product that uses a real-time polymerase chain reaction device, and is the first microsatellite instability diagnostic kit sold under the approval of the Ministry of Food and Drug Safety.” , "It is a product that demonstrates the technology commercialization capability of SeaSun Biomaterials in that it enables early market entry through the integrated approval review."

SeaSunbiomaterials is noting that in May, the FDA approved the immuno-cancer drug Kitruda as the first cancer treatment that can be prescribed to patients with specific genetic indicators (biomarkers) regardless of the site of cancer. This is because the U-TOP MSI Detection Kit is the first in vitro diagnostic device that can diagnose MSI, the biomarker that determines the prescription of Kitruda. Specifically, it is possible to prescribe Kitruda for adults and children with high microsatellite instability (MSI-H) or mismatch repair deficient (dMMR) characteristics, unresectable or metastatic solid tumors. Tumors with high microsatellite instability (MSI-H) are commonly found in colon cancer, endometrial cancer, and gastrointestinal cancer, but can also appear in breast cancer, prostate cancer, bladder cancer, and thyroid cancer.

A company official said, "In the case of organ-centered classification of indications based on the location of existing tumors, the location of the first cancer is an important classification criterion, so if imaging tests such as tomography are essential, classification of indications based on biomarkers. In the case of biomarkers, the importance of in vitro diagnostic tests according to the type of biomarker has increased. “In the future, we plan to enter the existing cancer classification diagnosis (colorectal cancer, gastric cancer, endometrial cancer, etc.) market by linking the biomarker market of immunotherapy drugs such as Kitruda "I emphasized.

SeaSun Biomaterials plans to continue developing products that diagnose biomarkers that can improve the treatment efficiency of cancer patients, not just the MSI diagnostic kit. It is conducting clinical trials by completing the development of a diagnostic kit for EBV (Epstein-Barr virus) related to gastric cancer, a diagnosis of Helicobacter pylori and an antibiotic resistance gene diagnosis product.