Contribution to the development of next-generation world-class products for microsatellite instability genotype discrimination molecular diagnostic products

SEASUN BIOMATERIALS (CEO Park Hee-kyung), a company specializing in genome-based molecular diagnostics, has contributed to the development of the 'U-TOP MSI Detection Kit', which is capable of analyzing microsatellite instability, which is essential for prescribing immunotherapy drugs. Received a commendation from the Minister of Merit.

The company was certified as a 'next-generation world-class product' with this diagnostic kit in 2019, and is making remarkable achievements in export growth and overseas network expansion every year. The world-class product system was introduced in 2001 by the Ministry of Trade, Industry and Energy and the Korea Trade-Investment Promotion Agency to enhance the global status and revitalize exports through brand certification of excellent domestic products. The award ceremony was held at the Lotte Hotel in Seoul on the 18th.

The next-generation world-class product is a certification awarded to items that are expected to satisfy the top 5 global market share or 5% or more within the next 7 years. It is decided through deliberation by an external expert, and the qualification must be met every year to maintain the qualification.

The 'U-TOP MSI Detection Kit' of SEASUN BIOMATERIALS is capable of differentially diagnosing the microsatellite instability (MSI) genotype. In December 2017, it received official approval from the Ministry of Food and Drug Safety for the first time in Korea, and through continuous development, it is expanding its indications for various types of cancer, including colorectal cancer, gastric cancer, and endometrial cancer. It is also undergoing the US Food and Drug Administration (FDA) certification process to enter the US market.

Microsatellite (microsatellite) is a part of the genome (DNA) in which short nucleotide sequences of 1 to 6 base pairs are repeated, accounting for about 5% of the total human DNA. Mistakes frequently occur in this section when replicating DNA, and if there is a problem in the repair function for mismatch errors, the accumulation of mutations is accelerated, leading to microsatellite instability (MSI) in which the length changes. If two or more of the 5 MSI-related markers (Bat25, Bat26, D2S123, D5S346, D17S250) are positive, high microsatellite instability (MSI-H), 1 low microsatellite instability (MSI-L), negative if brown rice This is called parasitization (MSS).

Global blockbuster immunotherapy, MSD's Keytruda (ingredient name: pembrolizumab) is monotherapy for highly microsatellite instability (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer Following the first approval from the Ministry of Food and Drug Safety, the MSI test is being used for customized prescription of Keytruda in various cancer types as the approved indications have been expanded to include endometrial cancer, stomach cancer, small intestine cancer, ovarian cancer, pancreatic cancer, and biliary tract cancer. As Keytruda's market share increases, the domestic and overseas market demand for SEASUN BIO's U-TOP MSI Detection Kit is also expected to increase.

Park Hee-kyung, CEO of SEASUN BIO, said, “This award is a meaningful award for the efforts of our employees who have devoted themselves to developing more accurate and convenient molecular diagnostic technology and products. This will be it,” he said.

Since its foundation, SEASUN BIOMATERIALS has focused on developing high-sensitivity molecular diagnostic technology and products. Diagnosis of cancer caused by genetic and epigenetic mutations, diagnosis for prognosis and prediction of immune anticancer drug reactivity, non-invasive prenatal test to check the genetic abnormality of the fetus based on maternal blood, genetic test for congenital hearing loss, Helicobacter pylori treatment drug We have a variety of molecular diagnostic products such as resistance diagnostics. Recently, they are spurring the development of molecular diagnostic products (panels) that can simultaneously diagnose multiple intractable cancers based on epigenetic genetic mutation biomarkers caused by environmental factors.