Information
306 Techno 2-ro, Yuseong District, Daejeon, South Korea
+82 42-867-6302
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Overview
- Summary
- Precision Biosensor Inc. is a medical device company specializing in the development and sale of diagnostic products essential for Point-of-Care Testing (POCT). The company's core business involves the research, development, and manufacturing of in-vitro diagnostic medical devices, aiming to become a global leader in providing diagnostic solutions for both human and animal health. A key characteristic is its high-sensitivity TRF (Time-Resolved Fluorescence) immunodiagnostic platform, which offers enhanced sensitivity compared to existing fluorescence products, and a multiplex clinical chemistry platform capable of analyzing up to nine metabolites simultaneously within 10 minutes.Precision Biosensor Inc. is a medical device company specializing in the development and sale of diagnostic products essential for Point-of-Care Testing (POCT). The company's core business involves the research, development, and manufacturing of in-vitro diagnostic medical devices, aiming to become a global leader in providing diagnostic solutions for both human and animal health. A key characteristic is its high-sensitivity TRF (Time-Resolved Fluorescence) immunodiagnostic platform, which offers enhanced sensitivity compared to existing fluorescence products, and a multiplex clinical chemistry platform capable of analyzing up to nine metabolites simultaneously within 10 minutes.
- Key Products/Technologies
- Exdia TRF Plus: An immunodiagnostic POCT platform utilizing TRF and optical technologies to achieve superior sensitivity over conventional fluorescence products. Its immunodiagnostic product line includes 14 types of cartridges for diagnosing various conditions such as cardiovascular, infectious, inflammatory, and oncological diseases.Exdia TRF Plus: An immunodiagnostic POCT platform utilizing TRF and optical technologies to achieve superior sensitivity over conventional fluorescence products. Its immunodiagnostic product line includes 14 types of cartridges for diagnosing various conditions such as cardiovascular, infectious, inflammatory, and oncological diseases.
- Exdia TRF: An immunodiagnostic platform based on high-sensitivity time-resolved fluorescence (TRF) technology, capable of detecting trace biomarkers in blood at picogram (pg) levels, demonstrating high sensitivity.Exdia TRF: An immunodiagnostic platform based on high-sensitivity time-resolved fluorescence (TRF) technology, capable of detecting trace biomarkers in blood at picogram (pg) levels, demonstrating high sensitivity.
- Exdia PT10/Exdia PT10S: A clinical chemistry POCT platform built on multiplex (Lab on a chip) technology, enabling simultaneous analysis of up to nine analytes within 6-10 minutes. It features an automated testing procedure with a minimal blood sample volume of 70μL. The product line includes 5 types of cartridges for human use (e.g., liver, lipid, comprehensive metabolic, HbA1c) and 11 types for animal use.Exdia PT10/Exdia PT10S: A clinical chemistry POCT platform built on multiplex (Lab on a chip) technology, enabling simultaneous analysis of up to nine analytes within 6-10 minutes. It features an automated testing procedure with a minimal blood sample volume of 70μL. The product line includes 5 types of cartridges for human use (e.g., liver, lipid, comprehensive metabolic, HbA1c) and 11 types for animal use.
- Exdia PT10V: A clinical chemistry platform specifically designed for companion animal diagnostics, providing fast and accurate animal health assessments. This includes the 'Exdia PT10V Liver Plus 12V', an animal liver diagnostic product with expanded test items and improved precision compared to previous versions.Exdia PT10V: A clinical chemistry platform specifically designed for companion animal diagnostics, providing fast and accurate animal health assessments. This includes the 'Exdia PT10V Liver Plus 12V', an animal liver diagnostic product with expanded test items and improved precision compared to previous versions.
- Nano-Check RSV Test: An in-vitro diagnostic rapid test kit for RSV (Respiratory Syncytial Virus), manufactured by its US subsidiary, Nano-Ditech. It has received official FDA 510(k) clearance and CLIA-Waived certification in the US.Nano-Check RSV Test: An in-vitro diagnostic rapid test kit for RSV (Respiratory Syncytial Virus), manufactured by its US subsidiary, Nano-Ditech. It has received official FDA 510(k) clearance and CLIA-Waived certification in the US.
- PBCheck COVID Flu Ag Combo / Exdia COVID Flu Ag Combo: Rapid diagnostic kits capable of simultaneously detecting COVID-19 and Influenza A/B. The PBCheck COVID Flu Ag Combo has obtained MFDS approval in Korea. The Nano-Check Influenza+COVID-19 Dual Test has received FDA Emergency Use Authorization (EUA) in the US.PBCheck COVID Flu Ag Combo / Exdia COVID Flu Ag Combo: Rapid diagnostic kits capable of simultaneously detecting COVID-19 and Influenza A/B. The PBCheck COVID Flu Ag Combo has obtained MFDS approval in Korea. The Nano-Check Influenza+COVID-19 Dual Test has received FDA Emergency Use Authorization (EUA) in the US.
- TRF Platform Technology: A technology that enhances sensitivity by replacing nano-gold particle labels with fluorescent materials. It provides image-based TRF POCT using elemental technologies such as simultaneous acquisition of image data, precise control of measurement time, and AI-based image processing.TRF Platform Technology: A technology that enhances sensitivity by replacing nano-gold particle labels with fluorescent materials. It provides image-based TRF POCT using elemental technologies such as simultaneous acquisition of image data, precise control of measurement time, and AI-based image processing.
- Multiplex Clinical Chemistry Platform Technology: Utilizes Lab on a chip technology for simultaneous analysis of multiple metabolites. It employs dry reagent and enzyme technology, eliminating the need for wet reagents and simplifying liquid waste disposal.Multiplex Clinical Chemistry Platform Technology: Utilizes Lab on a chip technology for simultaneous analysis of multiple metabolites. It employs dry reagent and enzyme technology, eliminating the need for wet reagents and simplifying liquid waste disposal.
- Core technologies include precise optical control, AI-based imaging processing, data connectivity, antibody engineering, microfluidics, and biological assay techniques.Core technologies include precise optical control, AI-based imaging processing, data connectivity, antibody engineering, microfluidics, and biological assay techniques.
- Core Advantages
- High-Sensitivity TRF (Time-Resolved Fluorescence) Technology: Achieves over 1,000 times higher sensitivity in biomarker detection, down to picogram (pg) levels, by utilizing Europium-based time-resolved fluorescence technology. This performance rivals large hospital laboratory equipment, overcoming limitations in POCT.High-Sensitivity TRF (Time-Resolved Fluorescence) Technology: Achieves over 1,000 times higher sensitivity in biomarker detection, down to picogram (pg) levels, by utilizing Europium-based time-resolved fluorescence technology. This performance rivals large hospital laboratory equipment, overcoming limitations in POCT.
- Integrated Solution Provision Capability: Through the integration of Nano-Ditech (US-based in-vitro diagnostic cartridge specialist) and Terawave (Korean diagnostic analyzer specialist), the company offers a total solution encompassing raw material supply, development, manufacturing, distribution, and sales of diagnostic reagents and analyzers.Integrated Solution Provision Capability: Through the integration of Nano-Ditech (US-based in-vitro diagnostic cartridge specialist) and Terawave (Korean diagnostic analyzer specialist), the company offers a total solution encompassing raw material supply, development, manufacturing, distribution, and sales of diagnostic reagents and analyzers.
- Broad Diagnostic Area Expandability and Open Innovation: Possesses expandability in diagnostic areas, covering both human and animal health, based on early diagnosis technology for protein-based biomarkers and biochemical metabolites. Actively pursues open innovation with global companies and research institutes holding various biomarkers to continuously introduce new biomarkers and platforms, and drive product commercialization.Broad Diagnostic Area Expandability and Open Innovation: Possesses expandability in diagnostic areas, covering both human and animal health, based on early diagnosis technology for protein-based biomarkers and biochemical metabolites. Actively pursues open innovation with global companies and research institutes holding various biomarkers to continuously introduce new biomarkers and platforms, and drive product commercialization.
- Global Quality System and Certifications: Secures core medical certifications such as FDA, CE, MFDS, and PMDA, and establishes a global quality system based on ISO 13485 and KGMP to ensure product quality and safety. Notably, the Nano-Check RSV Test is the only FDA-approved RSV diagnostic product available for sale in Korea.Global Quality System and Certifications: Secures core medical certifications such as FDA, CE, MFDS, and PMDA, and establishes a global quality system based on ISO 13485 and KGMP to ensure product quality and safety. Notably, the Nano-Check RSV Test is the only FDA-approved RSV diagnostic product available for sale in Korea.
- User Convenience and Automated System: The Exdia PT10/PT10S platform offers rapid results within 6-10 minutes, minimal sample volume of 70μL, and a simple 3-step testing procedure through dry reagent and automated plasma separation technology. This provides convenience for both medical professionals and patients, meeting key requirements for POCT products.User Convenience and Automated System: The Exdia PT10/PT10S platform offers rapid results within 6-10 minutes, minimal sample volume of 70μL, and a simple 3-step testing procedure through dry reagent and automated plasma separation technology. This provides convenience for both medical professionals and patients, meeting key requirements for POCT products.
- Focus on Digital Healthcare and Personalized Diagnostic Solutions: Possesses technology for providing effective treatment solutions through diagnostic data analysis and aims to enter the personalized healthcare market by developing next-generation healthcare platforms such as digital therapeutics.Focus on Digital Healthcare and Personalized Diagnostic Solutions: Possesses technology for providing effective treatment solutions through diagnostic data analysis and aims to enter the personalized healthcare market by developing next-generation healthcare platforms such as digital therapeutics.
- Target Industrie
- Medical and Healthcare Industry: Provides disease diagnosis and patient health management in various medical settings including hospitals, clinics, and pharmacies through Point-of-Care Testing (POCT) products. Covers a wide range of disease diagnostics such as cardiovascular diseases, infectious diseases (COVID-19, Influenza, RSV, Tuberculosis, etc.), inflammatory diseases, oncology, liver diseases, and diabetes.Medical and Healthcare Industry: Provides disease diagnosis and patient health management in various medical settings including hospitals, clinics, and pharmacies through Point-of-Care Testing (POCT) products. Covers a wide range of disease diagnostics such as cardiovascular diseases, infectious diseases (COVID-19, Influenza, RSV, Tuberculosis, etc.), inflammatory diseases, oncology, liver diseases, and diabetes.
- Animal Medical and Veterinary Industry: Offers animal disease diagnosis and health management through companion animal clinical chemistry diagnostic products (Exdia PT10V).Animal Medical and Veterinary Industry: Offers animal disease diagnosis and health management through companion animal clinical chemistry diagnostic products (Exdia PT10V).
- Digital Healthcare Industry: Provides personalized health management and monitoring solutions through diagnostic data analysis and the development of digital therapeutics.Digital Healthcare Industry: Provides personalized health management and monitoring solutions through diagnostic data analysis and the development of digital therapeutics.
- Major Markets
- South Korea, Japan, Saudi Arabia (planned), UAE (planned), Kuwait (planned), SingaporeSouth Korea, Japan, Saudi Arabia (planned), UAE (planned), Kuwait (planned), Singapore
- Italy, Germany, RomaniaItaly, Germany, Romania
- USAUSA
- Latin AmericaLatin America
- Certifications/Patents
- Holds over 370 diagnostic-related technology patents worldwide.Holds over 370 diagnostic-related technology patents worldwide.
- FDA (U.S. Food and Drug Administration) certification.FDA (U.S. Food and Drug Administration) certification.
- CE (Conformité Européenne) certification.CE (Conformité Européenne) certification.
- MFDS (Ministry of Food and Drug Safety, Korea) certification.MFDS (Ministry of Food and Drug Safety, Korea) certification.
- PMDA (Pharmaceuticals and Medical Devices Agency, Japan) certification.PMDA (Pharmaceuticals and Medical Devices Agency, Japan) certification.
- ISO 13485 (Medical devices quality management systems) certification.ISO 13485 (Medical devices quality management systems) certification.
- KGMP (Korea Good Manufacturing Practices) certification.KGMP (Korea Good Manufacturing Practices) certification.
- Innovative Medical Device Company certification (selected as an 'Innovation Leap' company).Innovative Medical Device Company certification (selected as an 'Innovation Leap' company).
- Selected as a Promising SME by Daejeon City in 2022.Selected as a Promising SME by Daejeon City in 2022.
- Awarded the Digital Innovation Award in 2018.Awarded the Digital Innovation Award in 2018.
Introduction
Location
306 Techno 2-ro, Yuseong District, Daejeon, South Korea
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