^
    8ms
    Gencurix selected as the world’s first new medical technology for endometrial cancer mutation testing…Non-covered prescriptions available (Gencurix Press Release)
    "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."
    Clinical
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    Droplex POLE Mutation Test
    1year
    Gencurix receives approval to sell 6 types of companion diagnostic products, Turkiye (Gencurix Press Release)
    "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."
    Non-US regulatory
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    Droplex BRAF Mutation Test • Droplex EGFR Mutation Test v2 • Droplex KRAS Mutation Test • Droplex PIK3CA Mutation Test • Droplex POLE Mutation Test • Droplex c-Met Exon14 Skipping Test
    1year
    Gencurix receives manufacturing approval from the Ministry of Food and Drug Safety for endometrial cancer test ‘Dropplex’ (Gencurix Press Release)
    "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."
    Non-US regulatory
    |
    Droplex POLE Mutation Test
    1year
    Gencurix approves endometrial cancer test ‘Dropplex’ in Australia (Gencurix Press Release)
    "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."
    Non-US regulatory
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    Droplex POLE Mutation Test
    over1year
    Gencurix supplies companion diagnostic kits to cancer center in India (KED Global)
    "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..."
    Clinical
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    Droplex POLE Mutation Test
    over1year
    Gencurix signs a cancer diagnosis kit supply contract with Biotype (Gencurix Press Release)
    "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."
    Licensing / partnership
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    Droplex BRAF Mutation Test • Droplex EGFR Mutation Test v2 • Droplex KRAS Mutation Test • Droplex PIK3CA Mutation Test • Droplex POLE Mutation Test • Droplex c-Met Exon14 Skipping Test
    over2years
    Gencurix "Utilization of company products for endometrial cancer mutation diagnosis research" (Gencurix Press Release)
    "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."
    Clinical data
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    Droplex POLE Mutation Test
    over2years
    Gencurix acquires European certification for 6 types of cancer companion diagnosis 'Dropplex' (Gencurix Press Release)
    "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)."
    European regulatory
    |
    Droplex BRAF Mutation Test • Droplex EGFR Mutation Test v2 • Droplex KRAS Mutation Test • Droplex PIK3CA Mutation Test • Droplex POLE Mutation Test • Droplex c-Met Exon14 Skipping Test