Information
206 Techno 2-ro, Yuseong District, Daejeon, South Korea
+82 44-850-9797
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Overview
- Summary
- Sugentech is a leading in-vitro diagnostics company leveraging bio, nano, and IT convergence technologies, providing personalized diagnostic solutions through its Multiplex Immunoblot, Point-of-Care Testing (POCT), and Digital Healthcare systems. The company implements smart mobile healthcare systems enabling disease prediction, prevention, diagnosis, customized prescriptions, and post-treatment monitoring. Notably, its development and global export of COVID-19 rapid diagnostic kits have established its international recognition. Sugentech possesses capabilities in developing and supplying diagnostic products across various fields, including allergies, autoimmune diseases, infectious diseases, and women's health.Sugentech is a leading in-vitro diagnostics company leveraging bio, nano, and IT convergence technologies, providing personalized diagnostic solutions through its Multiplex Immunoblot, Point-of-Care Testing (POCT), and Digital Healthcare systems. The company implements smart mobile healthcare systems enabling disease prediction, prevention, diagnosis, customized prescriptions, and post-treatment monitoring. Notably, its development and global export of COVID-19 rapid diagnostic kits have established its international recognition. Sugentech possesses capabilities in developing and supplying diagnostic products across various fields, including allergies, autoimmune diseases, infectious diseases, and women's health.
- Key Products/Technologies
- Multiplex Immunoblot System: Designed for general hospitals and examination centers, this system includes diagnostic reagents for over 100 types of allergens (SGTi-Allergy Screen, SGTi-Allergy Screen Plus) and ANA products for systemic autoimmune diseases. The semi-automated immunoblot analyzer S-Blot 2 Easy processes up to 12 strips, while S-Blot 2 handles up to 48 strips. The S-Blot3 is a fully automated device integrating reagent pretreatment and analysis.Multiplex Immunoblot System: Designed for general hospitals and examination centers, this system includes diagnostic reagents for over 100 types of allergens (SGTi-Allergy Screen, SGTi-Allergy Screen Plus) and ANA products for systemic autoimmune diseases. The semi-automated immunoblot analyzer S-Blot 2 Easy processes up to 12 strips, while S-Blot 2 handles up to 48 strips. The S-Blot3 is a fully automated device integrating reagent pretreatment and analysis.
- Point-of-Care Testing (POCT) System: This includes SGTi-flex line diagnostic kits for infectious diseases such as Influenza A&B, Dengue, and Tuberculosis, along with the INCLIX line for quantitative analysis of diabetes, cardiovascular diseases, hormones, CRP, and Total IgE. The INCLIX analyzer offers high accuracy with a superior CMOS sensor and proprietary algorithms, capable of storing 10,000 test results. Simultaneous COVID-19 and Influenza diagnostic products (SGTi-flex COVID-19 & Flu A/B Ag, SGTi-flexM COVID-19 & Flu A/B Ag) incorporate nanobead technology for easier interpretation.Point-of-Care Testing (POCT) System: This includes SGTi-flex line diagnostic kits for infectious diseases such as Influenza A&B, Dengue, and Tuberculosis, along with the INCLIX line for quantitative analysis of diabetes, cardiovascular diseases, hormones, CRP, and Total IgE. The INCLIX analyzer offers high accuracy with a superior CMOS sensor and proprietary algorithms, capable of storing 10,000 test results. Simultaneous COVID-19 and Influenza diagnostic products (SGTi-flex COVID-19 & Flu A/B Ag, SGTi-flexM COVID-19 & Flu A/B Ag) incorporate nanobead technology for easier interpretation.
- Digital Healthcare & Home Testing System: The Surearly SMART platform enables women's health management, including menstrual cycle, ovulation, and menopause symptoms, through the analysis of five female hormones. Surearly Digital Pregnancy Test and Ovulation Test provide self-diagnosis and result management features linked with mobile applications.Digital Healthcare & Home Testing System: The Surearly SMART platform enables women's health management, including menstrual cycle, ovulation, and menopause symptoms, through the analysis of five female hormones. Surearly Digital Pregnancy Test and Ovulation Test provide self-diagnosis and result management features linked with mobile applications.
- Nucleic Acid Molecular Diagnostic Technology: The Ampli & Array technology is an innovative diagnostic platform integrating Real-Time PCR and DNA Chip, applied in HPV (human papillomavirus) and multiplex tuberculosis testing. The company holds a US patent for a real-time quantitative and qualitative analysis method for biomaterials.Nucleic Acid Molecular Diagnostic Technology: The Ampli & Array technology is an innovative diagnostic platform integrating Real-Time PCR and DNA Chip, applied in HPV (human papillomavirus) and multiplex tuberculosis testing. The company holds a US patent for a real-time quantitative and qualitative analysis method for biomaterials.
- High-Sensitivity Analysis Technology: Acquisition of a patent for a 'time-resolved fluorescence signal analysis device,' crucial for developing high-sensitivity COVID-19 antigen diagnostic kits.High-Sensitivity Analysis Technology: Acquisition of a patent for a 'time-resolved fluorescence signal analysis device,' crucial for developing high-sensitivity COVID-19 antigen diagnostic kits.
- Core Advantages
- A leading total platform provider in in-vitro diagnostics, based on BT/NT/IT/AI convergence technology, encompassing diverse diagnostic areas like multiplex immunoblot, POCT, and digital healthcare.A leading total platform provider in in-vitro diagnostics, based on BT/NT/IT/AI convergence technology, encompassing diverse diagnostic areas like multiplex immunoblot, POCT, and digital healthcare.
- Proven capability in rapid development and commercialization of diagnostic kits, exemplified by its COVID-19 rapid diagnostic kits during the pandemic, enhancing global credibility and recognition.Proven capability in rapid development and commercialization of diagnostic kits, exemplified by its COVID-19 rapid diagnostic kits during the pandemic, enhancing global credibility and recognition.
- Extensive international certifications and regulatory approvals, including MDSAP, GMP, ISO13485, CE CoC, US FDA 510(k), and registrations, facilitating accelerated entry into global markets.Extensive international certifications and regulatory approvals, including MDSAP, GMP, ISO13485, CE CoC, US FDA 510(k), and registrations, facilitating accelerated entry into global markets.
- Provision of high diagnostic accuracy and reliability through proprietary high-sensitivity analysis technologies (time-resolved fluorescence signal analysis device) and precise multi-analysis algorithms.Provision of high diagnostic accuracy and reliability through proprietary high-sensitivity analysis technologies (time-resolved fluorescence signal analysis device) and precise multi-analysis algorithms.
- Establishment of a broad product lineup covering various disease areas such as allergies, autoimmune diseases, infectious diseases, and women's health, supported by continuous investment in research and development.Establishment of a broad product lineup covering various disease areas such as allergies, autoimmune diseases, infectious diseases, and women's health, supported by continuous investment in research and development.
- Development of automated and semi-automated diagnostic systems contributing to increased testing efficiency and reduction of human errors.Development of automated and semi-automated diagnostic systems contributing to increased testing efficiency and reduction of human errors.
- Pioneering efforts in exploring new promising markets, such as femtech with its female hormone self-diagnosis products.Pioneering efforts in exploring new promising markets, such as femtech with its female hormone self-diagnosis products.
- Target Industrie
- General Hospitals and Examination Centers: Application of diagnostic systems for allergies, autoimmune diseases, infectious diseases, and high-throughput sample processing.General Hospitals and Examination Centers: Application of diagnostic systems for allergies, autoimmune diseases, infectious diseases, and high-throughput sample processing.
- Small and Medium-sized Hospitals and Field Care Settings: Utilization of rapid and convenient Point-of-Care Testing (POCT) products for immediate diagnosis of infectious diseases and chronic conditions.Small and Medium-sized Hospitals and Field Care Settings: Utilization of rapid and convenient Point-of-Care Testing (POCT) products for immediate diagnosis of infectious diseases and chronic conditions.
- Personal and Home Healthcare: Provision of personalized health management services, including pregnancy, ovulation, and female hormone monitoring, through mobile app-linked self-diagnosis kits.Personal and Home Healthcare: Provision of personalized health management services, including pregnancy, ovulation, and female hormone monitoring, through mobile app-linked self-diagnosis kits.
- Public Health and Epidemiology: Role in rapid diagnosis and prevention of the spread of infectious diseases such as COVID-19 and influenza.Public Health and Epidemiology: Role in rapid diagnosis and prevention of the spread of infectious diseases such as COVID-19 and influenza.
- Major Markets
- Vietnam, Indonesia, Kazakhstan, China, Southeast Asia generalVietnam, Indonesia, Kazakhstan, China, Southeast Asia general
- Germany, Austria, Italy, Belgium, Greece, United Kingdom, Europe-wide (based on CE CoC)Germany, Austria, Italy, Belgium, Greece, United Kingdom, Europe-wide (based on CE CoC)
- United States, CanadaUnited States, Canada
- BrazilBrazil
- Certifications/Patents
- MDSAP (Medical Device Single Audit Program) Certification: Obtained qualification for exemption from medical device manufacturing facility audits in 3 countries including the US, Canada, and Brazil.MDSAP (Medical Device Single Audit Program) Certification: Obtained qualification for exemption from medical device manufacturing facility audits in 3 countries including the US, Canada, and Brazil.
- GMP and ISO13485 Certifications: Adherence to international standards for medical device manufacturing and quality management systems.GMP and ISO13485 Certifications: Adherence to international standards for medical device manufacturing and quality management systems.
- CE CoC (Certificate of Conformity) Acquisition: First Korean company to obtain European personal use approval for COVID-19 antigen/antibody self-test kits.CE CoC (Certificate of Conformity) Acquisition: First Korean company to obtain European personal use approval for COVID-19 antigen/antibody self-test kits.
- US FDA 510(k) Clearance: Approval for sales of two digital pregnancy test and pregnancy strip products in the US market.US FDA 510(k) Clearance: Approval for sales of two digital pregnancy test and pregnancy strip products in the US market.
- Patent for Time-Resolved Fluorescence Signal Analysis Device: Related to high-sensitivity analysis technology essential for COVID-19 rapid antigen diagnostic kit development.Patent for Time-Resolved Fluorescence Signal Analysis Device: Related to high-sensitivity analysis technology essential for COVID-19 rapid antigen diagnostic kit development.
- Patent for Multiplex Blot Test Automation System: Technology for automating blood tests for up to 60 patients.Patent for Multiplex Blot Test Automation System: Technology for automating blood tests for up to 60 patients.
- Ampli & Array Technology: A novel multiplex and quantitative analysis technology in molecular diagnostics (integrating Real-Time PCR and DNA Chip), with Health New Technology (NET) certification and European CE certification.Ampli & Array Technology: A novel multiplex and quantitative analysis technology in molecular diagnostics (integrating Real-Time PCR and DNA Chip), with Health New Technology (NET) certification and European CE certification.
- Awarded the '50 Million Dollar Export Tower': Recognized for export performance at the 59th Trade Day event in 2022.Awarded the '50 Million Dollar Export Tower': Recognized for export performance at the 59th Trade Day event in 2022.
- Innovative Medical Device Company Certification: Renewed certification from the Ministry of Health and Welfare, acknowledging its innovative technological capabilities.Innovative Medical Device Company Certification: Renewed certification from the Ministry of Health and Welfare, acknowledging its innovative technological capabilities.
Introduction
Location
206 Techno 2-ro, Yuseong District, Daejeon, South Korea
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