COMPANY:

Gencurix

"Gencurix announced...that it will present the research results of 'Colloidex', an early detection test for colorectal cancer, at the American Association for Cancer Research (AACR)...Gencurix will present the results of a study on the correlation between micro-survival cancer (MRD) and recurrence after colorectal cancer surgery using Colloid X."

"Gencurix announced...that it completed the registration of 600 patients for PMS and innovative medical technology research and expanded the coverage of breast cancer prognosis diagnosis service in earnest. As a result, most general hospitals can freely use Geneswell BCT for medical purposes without participating in clinical studies."

"Gencurix...announced on the 8th that it has completed the Japanese patent registration of 'Ginswell BCT', a breast cancer prognosis diagnosis product developed with its own technology. The patent is a technology that predicts a patient's risk of recurrence and metastasis by measuring the expression value of a specific gene in breast cancer tissue...Based on this patent registration, Gencurix plans to speed up the approval of 'Ginswell BCT' from Japan's Ministry of Food and Drug Safety (PMDA)."

"Avion and Gencurix, have been accused of violating trade secrets on cancer diagnosis-related technology in the United States...Ocimum Biosolutions claims Abion and Gencurix violated its database license rights while developing patents currently registered in the U.S."

"Gencurix announced on the 24th that it had confirmed the introduction of breast cancer prognosis diagnosis service with Acibadem Hospital, known as Turkey's best general hospital, at MEDICA 2022, held in Düsseldorf, Germany...The breast cancer prognosis service, which is being launched in Turkey, is a test that identifies low-risk patients who do not need chemotherapy as the risk of recurrence after breast cancer resection surgery is low. Probability of recurrence within 10 years after breast cancer resection surgery is predicted and provided."

"Gencurix announced on the 18th that it had introduced breast cancer diagnosis products to major hospital officials at the Breast Surgery Society 'Breastanbul 2022' held in Turkiye...Gencurix held a Geneswell BCT product briefing session for breast cancer specialists at Liv Hospital, Medicana Hospital, and American Hospital, including Acibadem Hospital, which represents Turkey."

"Gencurix...announced...that it has registered a domestic patent for a 'composition and kit for detecting epithelial growth factor receptor gene mutation' related to lung cancer companion diagnosis...The Geneswell ddEGFR mutation test developed based on this patent is the world’s first licensed and sold product based on the digital PCR platform."

"Gencurix announced on the 8th that it has received manufacturing and product approval for the 'Droplex BRAF Mutation Test', a thyroid cancer mutation test, from the Ministry of Food and Drug Safety...This product tests the presence of mutations in the 'BRAF' gene 'Codon600(V600E)', which occurs most commonly in thyroid cancer patients, using digital gene amplification (PCR) method. The V600E mutation accounts for more than 98% of BRAF mutations."

"Gencurix...announced...that the company's 'Droplet Digital PCR (ddPCR)' test method and product were used for a domestic research team's endometrial cancer mutation diagnosis research....Researchers at Hallym University Gangnam Sacred Heart Hospital and Bundang Seoul National University Hospital published a thesis titled 'Evaluation of the usefulness of a test method using ddPCR to detect pathogenic mutations in the POLE gene related to endometrial cancer' in the International Journal of Gynecological Oncology (Journal of Gynecological Oncology). It was published in the Journal of Gynecologic Oncology."

"Gencurix...announced on the 2nd that it had participated in the 'World Breast Cancer Conference GBCC 2022' and promoted 'Ginswell BCT', a prognostic test for breast cancer...Geneswell BCT is the first and only breast cancer prognostic diagnostic test in Asia that has obtained official approval from the Korean Ministry of Food and Drug Safety. Numerous clinical trials have proven that patients classified as low-risk through the test have a high survival rate with or without chemotherapy."

"Gencurix...announced on the 21st that it has obtained European certification (CE) for 6 types of 'Dropplex', a molecular diagnostic (PCR)-based cancer companion diagnostic product...Dropplex consists of products that target a total of six biomarkers (biomarkers) including lung cancer (EGFR v2, c-MET), colorectal cancer (KRAS), endometrial cancer (POLE), breast cancer (PIK3CA) and thyroid cancer (BRAF)."

"Gencurix...announced...it had received approval for the use of 'Ginswell BCT' in 28 general hospitals as of the end of last month by the Korea Health and Medical Research Institute (NECA)...Geneswell BCT is a breast cancer prognostic diagnostic test that predicts the prognosis of breast cancer patients through genetic analysis and classifies patients into low and high risk groups to inform whether they need chemotherapy treatment. Gencurix received approval from the Korean Ministry of Food and Drug Safety in 2017..."

"Gencurix...announced on the 25th that 'Composition for detecting epithelial cell growth factor receptor gene mutation and kit containing same' in the United States The patent has finally been obtained...The patent is about a method and kit composition for detecting EGFR mutations, which are mainly found in lung cancer patients. This was applied to 'Droplex EGFR Mutation Test (hereafter Dropplex EGFR), the world's first digital PCR-based IVD (medical device certification) product developed by Gencurix."

"Gencurix...will apply for clinical trial approval (IND) for Geneswell BCT, a breast cancer prognostic diagnostic tester, to the Japanese Ministry of Health in the first half of next year. Gencurix is ​​a molecular diagnostic analysis platform solution company...'Based on the clinical trial results of the Geneswell BCT study conducted at a Japanese hospital, we will publish a thesis in a prominent local academic journal in the first half of next year.' We plan to proceed with clinical trials for approval (PMDA).'"

"Liquid biopsy molecular diagnostics company Gencurix announced on the 6th that it has finally registered a US patent for methods for predicting risk of recurrence of breast cancer patients...The patent is about the biomarker and algorithm technology of Geneswell BCT independently developed by Gencurix."

"Gencurix...begins clinical trials of HEPA eDX, a liquid biopsy liver cancer early diagnosis test. If successful in clinical trials, HEPA eDX is expected to become the world's first commercially successful liver cancer early diagnosis product...The company aims to complete clinical trials by the first quarter of next year and complete approval from the Ministry of Food and Drug Safety within the first half of next year. The strategy is to make every effort to prepare for the official release at the same time as the approval."

"Gencurix announced...that a new clinical trial paper re-verifying the effectiveness of the breast cancer prognostic test GenesWell BCT was published in the international academic journal 'Frontiers in Oncology'...As a result of the study, the distant metastasis-free survival (DMFS) within 10 years of the low-risk group classified as Geneswell BCT was 96.9%. Gencurix has already demonstrated that patients who were judged as low-risk for Geneswell BCT through past clinical trials showed a high survival rate (96.2%) with or without chemotherapy. It was re-verified that the low-risk group had a high survival rate even without chemotherapy."