COMPANY:

Gencurix

"Gencurix will disclose two colorectal cancer clinical research results using its self-developed molecular diagnostic test method at the 2024 American Society of Clinical Oncology (ASCO) annual conference held on May 31."

"The Droplex POLE Mutation Test (endometrial cancer), which received manufacturing approval from the Ministry of Food and Drug Safety in 2023, was selected as a new medical technology with deferred evaluation, making non-reimbursement prescriptions possible...digital PCR-based endometrial cancer diagnostic kit is less expensive than existing diagnostic products and provides quick diagnostic results."

"Gencurix and HLB Group have decided to cooperate to target the global molecular diagnostics market...The first step is to enter into a business agreement with HLB Panagine for joint research and development and commercialization, as well as investment between the two companies."

"Gencurix's lung cancer companion diagnostic test (product name: Droplex EGFR Mutation Test v2) has been approved for sale in Australia...This is the second approval in Australia after endometrial cancer (POLE), and both products are the first digital PCR-based diagnostic products to be approved in Australia."

"Six types of Gencurix' companion diagnostic tests (Droplex) have been approved for sale in Turkiye, covering most of the Droplex test portfolio in Romania, Colombia, and Germany."

"Gencurix's Dropplex POLE mutation test, which is being recognized first overseas, has been approved by the Ministry of Food and Drug Safety. This test is for endometrial cancer patients and is a more accurate, faster, and more economical technology than existing testing methods. This product first received approval in Europe and Australia, and has also begun supply to India's largest national cancer hospital, Tata Medical Center."

"The results of the Korea-Japan joint clinical study announced at GBCC last April were published in a paper...This study succeeded in demonstrating the excellent performance of Geneswell BCT not only in Korea but also in Japanese patients, and showed that the prognosis prediction period is possible up to 15 years."

"Gencurix's breast cancer prognostic diagnosis 'Ginswell BCT' has applied to 4 new hospitals. Including this new hospital, a total of 54 medical institutions nationwide will provide GenesWell BCT services...The number of hospitals adopting Geneswell BCT has been steadily increasing since prescriptions for general medical treatment became possible in mid-April."

"Gencurix announced on the 4th that it received marketing approval for the Dropplex test from the Australian Department of Health and Aged Care...The product that received approval this time is Gencurix' liquid biopsy endometrial cancer mutation test, 'Droplex POLE Mutation Test'. This product is the world's first test kit capable of detecting POLE mutations using digital polymerase chain reaction (PCR) technology."

"Gencurix announced on the 6th that it signed a business agreement with DeepBio...Under the agreement, the two companies plan to jointly develop a business model to provide AI prostate cancer diagnostic testing services and begin the AI ​​cancer diagnostic service business in earnest."

"Gencurix...announced on the 29th that its companion diagnostic test had received approval from the Ministry of Food and Drug Safety in Thailand. The product approved this time is 'Droplex EGFR Mutation Test v2', a liquid biopsy companion diagnostic test for lung cancer from Gencurix."

"South Korean biotech company Gencurix Inc. on Friday said it started supplying its companion diagnostic test Droplex to a national cancer center in India...The Tata Memorial Centre in Mumbai is getting the Droplex POLE Mutation Test for genetic diagnosis of endometrial cancer..."

"Gencurix...announced...that the Korea Health and Medical Research Institute (NECA) has additionally approved hospitals to introduce the 'Ginswell BCT' test service for breast cancer...As Geneswell BCT became available for prescription for general medical purposes in mid-April, more hospitals are introducing it."

"Molecular diagnosis company Gencurix's companion diagnostic platform 'Droplex' received sales permission from the UAE Ministry of Health and Welfare on the 9th...The product approved this time is 'Droplex EGFR Mutation Test v2', a liquid biopsy companion diagnostic test for lung cancer. It can detect a total of 107 gene mutations and is characterized by improved accuracy by using highly sensitive digital gene amplification (PCR) technology."

"Gencurix announced on the 5th that six hospitals in Korea have newly applied for the introduction of 'Ginswell BCT'...a prognostic diagnosis service for breast cancer...Gencurix will provide Geneswell BCT service at a total of 50 medical institutions nationwide, including six newly introduced locations. According to Gencurex, Geneswell BCT has been available for prescription for general medical purposes since last April, and more hospitals are introducing it."

"Gencurix...has obtained approval from the Korean Ministry of Food and Drug Safety for its Droplex EGFR Mutation Test v2. This product is a companion diagnostic test designed to detect EGFR mutations commonly found in NSCLC patients and guide the selection of appropriate targeted anticancer therapies based on the test results....Compared to existing EGFR mutation tests using RT-PCR, this product demonstrates significantly higher sensitivity. This makes it capable of accurately detecting mutations even when plasma samples are used as the specimen....Notably, this product has an additional strength in its ability to detect Exon 20 Insertion..."

"Gencurix announced...that it had signed a local agency supply contract with German Biotype...Gencurix plans to supply the Dropplex diagnostic kit, a digital PCR-based cancer companion diagnostic product, to Germany and other European countries through Biotype. Gencurix received European in vitro diagnostic medical device certification (CE-IVD) for six Dropplex products."

"Gencurix...announced on the 7th that 'Dropplex EGFR Mutation Test V2' has obtained manufacturing permission from the Ministry of Food and Drug Safety...Gencurix's Dropplex EGFR Mutation Test V2 is a diagnostic kit product that enables patients to select the most suitable targeted therapy by detecting mutations in the EGFR test, which is the most basic and important test in the field of cancer companion diagnosis."

"Gencurix...announced the release of clinical research results directly comparing the accuracy of its breast cancer prognostic test, GenesWell BCT, with Oncotype DX, the globally top-selling test, confirming its outstanding performance....The results revealed that GenesWell BCT demonstrated a superior prognostic performance in accurately distinguishing high-risk and low-risk groups, with a Hazard Ratio of 2.469 for high-risk recurrence compared to 2.093 for OncotypeDX. This difference in favor of GenesWell BCT was even more pronounced in subgroup analyses based on lymph node metastasis."

"Gencurix announced...that 11 organizations applied for the use of Geneswell BCT to the Korea Health and Medical Research Institute (NECA) at the end of March and received final approval. The Korea Health and Medical Research Institute is an institution under the Ministry of Health and Welfare, and manages innovative medical technology implementation institutions."

"Gencurix...announced...that it would present the results of prognostic diagnosis clinical trials conducted on 366 Korean and Japanese breast cancer patients at the World Breast Cancer Conference (GBCC) to be held in Seoul...Gencurix's 'Ginswell BCT' was used to predict the prognosis of breast cancer...83.6% were classified as low-risk and 16.4% as high-risk. Clinical results showed that patients in the low-risk group had a significantly higher survival rate after surgery than those in the high-risk group."

"Gencurix...announced...that it had published a study showing that early colorectal cancer detection tests predicted colorectal cancer recurrence with 100% sensitivity prior to imaging tests...Gencurix utilized COLO eDX, an early detection test for colorectal cancer, to treat microscopic residual cancer after surgery..."

"Gencurix selected as the topic of presentation at the American Society of Clinical Oncology (ASCO) the results of a clinical study that directly compared the accuracy of its breast cancer prognostic test, Geneswell BCT, and Oncotype DX, the global top seller..."

"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."