D--46
Gold
SML Genetree is the fastest-growing company in the field of molecular diagnostics since its establishment. Leading developer of multiplex molecular technologies and multiplex clinical molecular diagnostics based in South Korea. SML Genetree is recognized as a premier partner in developing technology and on-time delivery, providing both basic research of molecular biology and applied research in molecular diagnosis. In particular, as the world's first successful commercialization of 'Ezplex® HPV 100 NGS Kit', it has received favorable reviews from domestic and foreign research institutes. Since its launch, it has continued to grow remarkably, serving as a model for Korea's exemplary bio-venture company. In addition, by thoroughly examining the growth potential and profitability of products and services from the beginning of establishment, we are succeeding in developing and commercializing the most products among molecular diagnostic companies in recent years with a strategy to streamline the period from product development to sales. The strategy to focus on the development of a small number of Mega Hit products as an innovation method and at the same time to pursue the performance improvement of the popular diagnostic kit through an improvement method is the most revealing characteristic of SML Genetree. In 2020, SML Genetree established SML Genetree Sciences in the US to expand the market. Using this as a foothold, we are advancing into the global market. SML Genetree is an affiliate of Samkwang Medical Laboratories (SML), one of the largest diagnostic commercial labs in South Korea since 1985. SML has continued to provide diagnostic results to customers across 3,000 government medical institutions in South Korea, including the Military Manpower (MMA), university hospitals, and local medical institutions. In 2020, SML conducted more than 250,000 clinical trial tests for Covid-19. Meditree and Labtree, affiliates of SML, also support SML genetree through related projects, such as Central Lab Service/CRO and vaccine R&D. Ezplex® SARS-CoV-2 FAST G Kit The Korean Ministry of Food and Drug Safety (MFDS) has received approval for emergency use of a COVID-19 diagnostic reagent for the purpose of emergency screening by the Korea Centers for Disease Control and Prevention. It is also a product that has received approval from the Philippine FDA and UAE MOH. Ezplex SARS-CoV-2 G Kit It has the advantage of high sensitivity and specificity compared to other diagnostic kits, and based on this, the pooling test method was recognized for the first time in Korea in January 2021, and an emergency use authorization (EUA) was obtained from the US Food and Drug Administration (FDA). and has been officially approved by the Ministry of Food and Drug Safety (MFDS) in Korea. Ezplex® Respiratory Pathogen Real-time PCR Kit It is a reagent that qualitatively detects 19 types of respiratory viruses and 6 types of pneumonia-causing bacteria simultaneously or alone. Registered with Thai FDA, Turkish MOH, and CE-IVD. Ezplex™ MTBC/NTM Real-time PCR Kit It is a reagent that simultaneously detects Mycobacterium tuberculosis (MTBC) and more than 100 types of non-tuberculous Mycobacterium (NTM). It has been officially approved by the Ministry of Food and Drug Safety (MFDS) in Korea and has been registered with the Thai FDA, Turkish MOH, and CE-IVD overseas. We are continuing the research results created based on the world's best genome research capabilities and rich experience as customer value. Although it is already being evaluated as the best molecular diagnostics company in Korea through the establishment of an efficient and value-oriented management system and the creation of performance in the global market, we will not stop there.
Ezplex® SARS-CoV-2 G Kit, developed by SML Genetree, is a product that has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). This is an in vitro diagnostic test that qualitatively detects the nucleic acids of SARS-CoV-2 (RdRp and N genes) in sputum to aid in emergency screening for COVID-19. This product can be used for a large amount of screening tests because it can perform a pooling test, unlike the products that the existing domestic companies have approved for emergency use by the FDA. For the combined test, samples are collected in units of 5 people and tested. If positive, individual tests are performed. In the case of a negative test, all tests are performed in a negative way. In particular, since a large number of samples are tested at once, the test is only possible with high sensitivity and specificity compared to existing diagnostic kits. According to the FDA, it was confirmed that 100% agreement was achieved in the result comparison test of individual and collective tests, and it was the 20th in the world and the first Korean company to pass the test. Excellent clinical performance was demonstrated by confirming high sensitivity and specificity through clinical evaluation, and stability was confirmed for 12 months through long-term storage tests. In January 2021, it was officially approved by the Korean Ministry of Food and Drug Safety (MFDS).
Helicobacter pylori is a parasitic bacterium in the stomach that lives between the gastric mucosa and mucus. According to the WHO, more than half of the world's population has H. pylori and is the third leading cause of cancer-related deaths. In 1994, the WHO's IARC classified H. Pylori as a Class 1 carcinogen. The incidence of H. pylori in developing countries is the highest worldwide, highlighting the need for highly accurate and manageable testing. By 2025, the H. pylori testing market is expected to be worth 6 billion. Accordingly, SML Genetree has developed a reagent that can diagnose Helico-bacter pylori and Clarithromycin-resistant mutants (A2142G, A2143G) through DNA extracted from human hygienic tissue using Real-time Polymerase Chain Reaction. Since it contains multiple gene regions, Helico-bacter pylori and Clarithromycin-resistant mutations can be detected sensitively, and high reproducibility has been demonstrated through repeated tests by serially diluting various positive samples and standards. In addition, as a result of clinical evaluation on human sanitary inspection tissue by commissioning a large domestic consignment inspection institution, high sensitivity and specificity were confirmed, proving its excellent clinical performance.
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