Information
243 Digital-ro, Guro District, Seoul, South Korea
+82 2-2224-7630
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Overview
- Summary
- Gencurix, established in 2011, is a specialized biomolecular diagnostics company. The company focuses on developing early cancer diagnostic kits, aiming to enable healthier and better lives for patients. It functions as a specialized developer of molecular diagnostic platforms, establishing total solutions for cancer diagnosis. Utilizing liquid biopsy-based molecular diagnostic technology, it manufactures and sells diagnostic kits for early diagnosis, prognostic diagnosis, and companion diagnostics of cancer. Gencurix holds a unique position as Korea's only specialized digital PCR (Polymerase Chain Reaction) diagnostics company for cancer.Gencurix, established in 2011, is a specialized biomolecular diagnostics company. The company focuses on developing early cancer diagnostic kits, aiming to enable healthier and better lives for patients. It functions as a specialized developer of molecular diagnostic platforms, establishing total solutions for cancer diagnosis. Utilizing liquid biopsy-based molecular diagnostic technology, it manufactures and sells diagnostic kits for early diagnosis, prognostic diagnosis, and companion diagnostics of cancer. Gencurix holds a unique position as Korea's only specialized digital PCR (Polymerase Chain Reaction) diagnostics company for cancer.
- Key Products/Technologies
- GenesWell BCT: A prognostic diagnostic test for breast cancer that predicts the probability of distant metastasis and recurrence within 10 years, as well as the effectiveness of chemotherapy for early breast cancer patients. Developed and validated with samples from Korean breast cancer patients, making it suitable for the Korean population, and holding the sole KFDA approval (Medical Device Permit No. 16-800) with eligibility for private health insurance coverage in Korea. Reliability is ensured through published clinical studies involving over 3,200 Korean subjects. The test offers rapid results, available within one week of request.GenesWell BCT: A prognostic diagnostic test for breast cancer that predicts the probability of distant metastasis and recurrence within 10 years, as well as the effectiveness of chemotherapy for early breast cancer patients. Developed and validated with samples from Korean breast cancer patients, making it suitable for the Korean population, and holding the sole KFDA approval (Medical Device Permit No. 16-800) with eligibility for private health insurance coverage in Korea. Reliability is ensured through published clinical studies involving over 3,200 Korean subjects. The test offers rapid results, available within one week of request.
- GenesWell ddEGFR Mutation Test: A companion diagnostic test for non-small cell lung cancer (NSCLC) patients, identifying the presence of 45 EGFR (Epidermal Growth Factor Receptor) mutations. It plays a role in selecting patients for targeted anticancer drug therapy, supporting personalized treatment. The application of ddPCR (droplet digital PCR) technology ensures higher sensitivity and accuracy compared to conventional PCR-based products. This high-sensitivity technology allows for the detection of mutations at a 0.8% allele frequency.GenesWell ddEGFR Mutation Test: A companion diagnostic test for non-small cell lung cancer (NSCLC) patients, identifying the presence of 45 EGFR (Epidermal Growth Factor Receptor) mutations. It plays a role in selecting patients for targeted anticancer drug therapy, supporting personalized treatment. The application of ddPCR (droplet digital PCR) technology ensures higher sensitivity and accuracy compared to conventional PCR-based products. This high-sensitivity technology allows for the detection of mutations at a 0.8% allele frequency.
- Droplex: A product line of digital PCR-based oncology diagnostic kits. It possesses multiplexing technology capable of simultaneously detecting 107 EGFR mutations, the most frequent mutation in lung cancer. Recently, the 'Droplex LC Panel' was developed to simultaneously diagnose 180 mutations across 11 major lung cancer genes, including KRAS, cMET, and HER2, in addition to EGFR. The company has also obtained KFDA manufacturing approval for its endometrial cancer diagnostic kit.Droplex: A product line of digital PCR-based oncology diagnostic kits. It possesses multiplexing technology capable of simultaneously detecting 107 EGFR mutations, the most frequent mutation in lung cancer. Recently, the 'Droplex LC Panel' was developed to simultaneously diagnose 180 mutations across 11 major lung cancer genes, including KRAS, cMET, and HER2, in addition to EGFR. The company has also obtained KFDA manufacturing approval for its endometrial cancer diagnostic kit.
- eDX (Early Diagnosis eDX): A liquid biopsy-based early diagnostic test that detects cancer early by examining methylation of cancer-specific biomarkers in DNA from blood. It demonstrates high cancer specificity, clearly distinguishing between normal and cancerous states. The test offers convenience by providing accurate results with a simple blood draw, eliminating the need for complex preparations. The product lineup includes 'HEPA eDX' for early liver cancer diagnosis and 'COLO eDX' for early colorectal cancer diagnosis.eDX (Early Diagnosis eDX): A liquid biopsy-based early diagnostic test that detects cancer early by examining methylation of cancer-specific biomarkers in DNA from blood. It demonstrates high cancer specificity, clearly distinguishing between normal and cancerous states. The test offers convenience by providing accurate results with a simple blood draw, eliminating the need for complex preparations. The product lineup includes 'HEPA eDX' for early liver cancer diagnosis and 'COLO eDX' for early colorectal cancer diagnosis.
- GenoCTC ver.3: A circulating tumor cell (CTC) capture device capable of rapidly and accurately isolating extremely rare CTCs from whole blood. It utilizes next-generation Magnetoelectrophoresis technology, incorporating a microfluidic system. The device enhances convenience through an automated process that uses whole blood directly without pre-processing. It offers high CTC isolation performance and prevents cross-contamination through the use of disposable cartridges.GenoCTC ver.3: A circulating tumor cell (CTC) capture device capable of rapidly and accurately isolating extremely rare CTCs from whole blood. It utilizes next-generation Magnetoelectrophoresis technology, incorporating a microfluidic system. The device enhances convenience through an automated process that uses whole blood directly without pre-processing. It offers high CTC isolation performance and prevents cross-contamination through the use of disposable cartridges.
- Core Advantages
- Provision of cancer diagnostic solutions specialized for Asians: GenesWell BCT was developed and validated with samples from Korean breast cancer patients, making it suitable for the Korean population, and has demonstrated superior prognostic prediction performance compared to the global leading product in international academic journals. As the only KFDA-approved breast cancer prognostic diagnostic test eligible for private health insurance coverage in Korea, it secures a unique position in the domestic market.Provision of cancer diagnostic solutions specialized for Asians: GenesWell BCT was developed and validated with samples from Korean breast cancer patients, making it suitable for the Korean population, and has demonstrated superior prognostic prediction performance compared to the global leading product in international academic journals. As the only KFDA-approved breast cancer prognostic diagnostic test eligible for private health insurance coverage in Korea, it secures a unique position in the domestic market.
- Unrivaled digital PCR-based technology: Gencurix is the world's first company to develop a companion diagnostic kit for cancer, possessing ddPCR platform technology with high sensitivity and accuracy. It holds multiplexing technology capable of simultaneously diagnosing 107 EGFR mutations, the most frequent mutation in lung cancer, as well as 180 mutations across 11 major lung cancer genes including KRAS, cMET, and HER2. This technological capability plays a crucial role in generating key data during the drug development process.Unrivaled digital PCR-based technology: Gencurix is the world's first company to develop a companion diagnostic kit for cancer, possessing ddPCR platform technology with high sensitivity and accuracy. It holds multiplexing technology capable of simultaneously diagnosing 107 EGFR mutations, the most frequent mutation in lung cancer, as well as 180 mutations across 11 major lung cancer genes including KRAS, cMET, and HER2. This technological capability plays a crucial role in generating key data during the drug development process.
- Strategic partnerships with global top-tier companies: The company has signed an exclusive distribution agreement with Bio-Rad Laboratories (USA) for digital PCR-based oncology diagnostic kits in 32 European countries. A joint development and global exclusive distribution agreement for digital PCR-based cancer diagnostic products with QIAGEN (Germany) is accelerating its expansion into the global market. Collaborations in cancer molecular diagnostics with Hitachi High-Tech (Japan) and Roche Diagnostics Korea are further accelerating global market entry.Strategic partnerships with global top-tier companies: The company has signed an exclusive distribution agreement with Bio-Rad Laboratories (USA) for digital PCR-based oncology diagnostic kits in 32 European countries. A joint development and global exclusive distribution agreement for digital PCR-based cancer diagnostic products with QIAGEN (Germany) is accelerating its expansion into the global market. Collaborations in cancer molecular diagnostics with Hitachi High-Tech (Japan) and Roche Diagnostics Korea are further accelerating global market entry.
- Comprehensive diagnostic portfolio covering the entire cancer continuum: Gencurix has established solutions across the full spectrum of cancer diagnosis, including early diagnostic products for liver and colorectal cancer (HEPA eDX, COLO eDX), prognostic diagnostic products for breast cancer (GenesWell BCT), and companion diagnostic products for lung cancer (GenesWell ddEGFR Mutation Test, Droplex). This provides an integrated approach for personalized patient treatment.Comprehensive diagnostic portfolio covering the entire cancer continuum: Gencurix has established solutions across the full spectrum of cancer diagnosis, including early diagnostic products for liver and colorectal cancer (HEPA eDX, COLO eDX), prognostic diagnostic products for breast cancer (GenesWell BCT), and companion diagnostic products for lung cancer (GenesWell ddEGFR Mutation Test, Droplex). This provides an integrated approach for personalized patient treatment.
- Strength in non-invasive diagnosis through liquid biopsy technology: Based on liquid biopsy, a next-generation diagnostic technology that overcomes the limitations of tissue biopsy, the company offers non-invasive and repeatable tests. Its technology can analyze DNA in blood for early cancer detection and is applicable for recurrence monitoring. Strengthening its core liquid biopsy technology capabilities through acquiring a stake in Ginobio, which possesses circulating tumor cell (CTC) isolation technology.Strength in non-invasive diagnosis through liquid biopsy technology: Based on liquid biopsy, a next-generation diagnostic technology that overcomes the limitations of tissue biopsy, the company offers non-invasive and repeatable tests. Its technology can analyze DNA in blood for early cancer detection and is applicable for recurrence monitoring. Strengthening its core liquid biopsy technology capabilities through acquiring a stake in Ginobio, which possesses circulating tumor cell (CTC) isolation technology.
- Target Industrie
- Medical and Healthcare IndustryMedical and Healthcare Industry
- Molecular Diagnostics IndustryMolecular Diagnostics Industry
- Precision Medicine SectorPrecision Medicine Sector
- Cancer Diagnosis and Treatment FieldCancer Diagnosis and Treatment Field
- Life Science and Genetic Engineering ResearchLife Science and Genetic Engineering Research
- Major Markets
- South Korea, Turkey, Thailand, Japan, Southeast AsiaSouth Korea, Turkey, Thailand, Japan, Southeast Asia
- 32 European countries (including UK, Germany, France)32 European countries (including UK, Germany, France)
- USAUSA
- AustraliaAustralia
- Central and South AmericaCentral and South America
- Certifications/Patents
- KGMP (Korea Good Manufacturing Practice) certificationKGMP (Korea Good Manufacturing Practice) certification
- EN ISO13485:2016 Quality Management System establishment and certificationEN ISO13485:2016 Quality Management System establishment and certification
- ISO 9001:2015 certificationISO 9001:2015 certification
- GenesWell BCT: KFDA product approval (Medical Device Permit No. 16-800)GenesWell BCT: KFDA product approval (Medical Device Permit No. 16-800)
- GenesWell BCT: Selected as an Innovative Medical Technology by NECA (National Evidence-based Healthcare Collaborating Agency) in 2020GenesWell BCT: Selected as an Innovative Medical Technology by NECA (National Evidence-based Healthcare Collaborating Agency) in 2020
- GenesWell BCT: Listed for non-reimbursable coverage by the Ministry of Health and Welfare in 2023GenesWell BCT: Listed for non-reimbursable coverage by the Ministry of Health and Welfare in 2023
- Droplex-based cancer gene mutation tests (4 types: endometrial cancer (POLE), colorectal cancer (KRAS), thyroid cancer (BRAF), non-small cell lung cancer (cMET)): Obtained European CE-IVDR certification (January 2026)Droplex-based cancer gene mutation tests (4 types: endometrial cancer (POLE), colorectal cancer (KRAS), thyroid cancer (BRAF), non-small cell lung cancer (cMET)): Obtained European CE-IVDR certification (January 2026)
- COVID-19 diagnostic kit (GenePro SARS-CoV-2 Test): Obtained US FDA EUA (Emergency Use Authorization)COVID-19 diagnostic kit (GenePro SARS-CoV-2 Test): Obtained US FDA EUA (Emergency Use Authorization)
- Possession of proprietary technologies including cancer-specific biomarker development platform, rapid extraction, isothermal amplification, gene-editing based rapid molecular diagnostic technology, and algorithm/analysis software design technologyPossession of proprietary technologies including cancer-specific biomarker development platform, rapid extraction, isothermal amplification, gene-editing based rapid molecular diagnostic technology, and algorithm/analysis software design technology
Introduction
Location
243 Digital-ro, Guro District, Seoul, South Korea
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