COMPANY:

Gencurix

"QIAGEN...today announced a new partnership to develop oncology assays for use on the QIAcuityDx platform, a high-performance digital PCR system designed for clinical diagnostics."

"Gencurix announced on the 11th that it will present the results of a study proving the effectiveness of 'HEPA eDX', a new molecular genetic testing method for early diagnosis of liver cancer, at the 2024 European Society for Medical Oncology (ESMO 2024), to be held from the 13th to the 17th....In this study, HEPA eDX tests were performed on cell lines and tissues of various cancers including liver cancer, as well as the blood of actual liver cancer patients, and the results confirmed that the methylation level of the biomarker was significantly higher in liver cancer than in other cancers." "

"On August 8, Gencurix signed a business agreement for cancer molecular diagnosis with Hitachi High-Technologies and began jointly developing cancer molecular diagnosis testing services for the Japanese market...The two companies plan to jointly develop cancer diagnostic tests required in clinical settings to promote personalized medicine in the cancer field and provide reliable testing service solutions utilizing digital technologies. They will first begin their testing service business in Japan and aim to further cooperate in the global market."

"Our research abstracts proving the clinical utility of our Dropplex lung cancer panel test have been accepted by ASCO Breakthrough and the World Congress of Lung Cancer in 2024. At ASCO Breakthrough, we presented the results proving that our Dropplex lung cancer panel test can detect 180 mutations in 11 genes related to lung cancer through liquid biopsies such as cancer tissue and blood. At the World Congress of Lung Cancer to be held on September 8, we plan to present that our Dropplex lung cancer panel test showed consistency in the diagnostic results of the NGS diagnostic method in a clinical study conducted on 35 patients with non-small cell lung cancer (NSCLC)."

"Gencurix...announced...that its abstract of a performance study on a companion diagnostic test for lung cancer was accepted at the 2024 ASCO Breakthrough (American Society of Clinical Oncology)...Gencurix's 'Droplex NSCLC Panel Test' is a digital PCR-based lung cancer companion diagnostic test that can detect multiple genetic mutations simultaneously. In this research abstract, an innovative technology was announced that can detect 180 mutations in 11 lung cancer-related genes through liquid biopsies such as blood as well as cancer tissue."

"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."