Information
Overview
- Summary
- Established in 2009, Biodyne Co., Ltd. is a specialized manufacturer developing and producing PATHPLORER LBC System diagnostic equipment and reagents for cancer diagnosis. The company maintains a leading market share in the domestic liquid-based cytology (LBC) examination market, based on its proprietary patented Blowing Technology. This technology is a core capability enabling fast, accurate, and convenient cancer diagnosis. A key characteristic is its pursuit of global market expansion through a technology transfer and exclusive sales agreement with the global in-vitro diagnostics company Roche.Established in 2009, Biodyne Co., Ltd. is a specialized manufacturer developing and producing PATHPLORER LBC System diagnostic equipment and reagents for cancer diagnosis. The company maintains a leading market share in the domestic liquid-based cytology (LBC) examination market, based on its proprietary patented Blowing Technology. This technology is a core capability enabling fast, accurate, and convenient cancer diagnosis. A key characteristic is its pursuit of global market expansion through a technology transfer and exclusive sales agreement with the global in-vitro diagnostics company Roche.
- Key Products/Technologies
- PATHPLORER LBC System: A flagship product for cancer diagnosis, including equipment and reagents for liquid-based cytology, boasting a high market share in Korea. This system comprises a diagnostic kit including cell processing solution, membrane filters, smear slides, and collection brushes.PATHPLORER LBC System: A flagship product for cancer diagnosis, including equipment and reagents for liquid-based cytology, boasting a high market share in Korea. This system comprises a diagnostic kit including cell processing solution, membrane filters, smear slides, and collection brushes.
- PATHPLORER AUTO LBC System: An automated instrument that handles the entire process from filter, vial, and slide supply to slide preparation and storage via suction blowing, primarily supplied to university general hospitals.PATHPLORER AUTO LBC System: An automated instrument that handles the entire process from filter, vial, and slide supply to slide preparation and storage via suction blowing, primarily supplied to university general hospitals.
- PATHPLORER PLUS LBC System: A semi-automatic instrument for research laboratories and cancer screening centers, featuring a 4.7 model focused on slide preparation speed and a 4.63 model with an external air tank.PATHPLORER PLUS LBC System: A semi-automatic instrument for research laboratories and cancer screening centers, featuring a 4.7 model focused on slide preparation speed and a 4.63 model with an external air tank.
- PATHPLORER ECO: A compact, practical instrument primarily sold to small hospitals.PATHPLORER ECO: A compact, practical instrument primarily sold to small hospitals.
- Blowing Technology: A proprietary core technology developed by CEO Lim Wook-bin, based on Pascal's principle, enabling uniform monolayer cell smearing without cell damage or deformation by providing consistent pressure. This unique capability enhances the precision, efficiency, and reliability of cancer cell diagnosis, bringing diagnostic accuracy close to 100%.Blowing Technology: A proprietary core technology developed by CEO Lim Wook-bin, based on Pascal's principle, enabling uniform monolayer cell smearing without cell damage or deformation by providing consistent pressure. This unique capability enhances the precision, efficiency, and reliability of cancer cell diagnosis, bringing diagnostic accuracy close to 100%.
- VENTANA SP 400: Roche's liquid-based cytology (LBC) instrument incorporating Biodyne's Blowing Technology, expected for global launch in Q4 2024 and first launched in the Japanese market in June 2025. This instrument strengthens Roche's cervical cancer screening portfolio and opens new opportunities in the non-gynecological cytopathology market.VENTANA SP 400: Roche's liquid-based cytology (LBC) instrument incorporating Biodyne's Blowing Technology, expected for global launch in Q4 2024 and first launched in the Japanese market in June 2025. This instrument strengthens Roche's cervical cancer screening portfolio and opens new opportunities in the non-gynecological cytopathology market.
- Earlypap Brush: A self-sampling brush for cervical cancer cells, utilizing a patented 'Bloom & Grip Technology' where the brush blooms like a flower and firmly grips cells. Developed for patient convenience, it is suitable for use in medically underserved areas and enables efficient diagnosis of HPV, STD, and cytology.Earlypap Brush: A self-sampling brush for cervical cancer cells, utilizing a patented 'Bloom & Grip Technology' where the brush blooms like a flower and firmly grips cells. Developed for patient convenience, it is suitable for use in medically underserved areas and enables efficient diagnosis of HPV, STD, and cytology.
- Core Advantages
- Proprietary Patented Blowing Technology: A unique technological capability that maximizes the precision, efficiency, and reliability of cancer diagnosis by uniformly applying specimens to slides without cell damage. This differentiates the company by improving upon existing LBC methods and offering superior sensitivity compared to competitors.Proprietary Patented Blowing Technology: A unique technological capability that maximizes the precision, efficiency, and reliability of cancer diagnosis by uniformly applying specimens to slides without cell damage. This differentiates the company by improving upon existing LBC methods and offering superior sensitivity compared to competitors.
- Long-term Exclusive Agreement with Global Top Diagnostics Company Roche: Secured a stable revenue structure by signing a technology transfer and exclusive sales agreement in 2019, finalized in 2022 for a 20-year royalty stream until 2039. This provides an opportunity for global recognition of its technology through Roche's worldwide distribution network.Long-term Exclusive Agreement with Global Top Diagnostics Company Roche: Secured a stable revenue structure by signing a technology transfer and exclusive sales agreement in 2019, finalized in 2022 for a 20-year royalty stream until 2039. This provides an opportunity for global recognition of its technology through Roche's worldwide distribution network.
- Leading Market Share in Domestic Liquid-Based Cytology Market: Maintains a top market share in the domestic market through the development and production of PATHPLORER LBC System diagnostic equipment and reagents.Leading Market Share in Domestic Liquid-Based Cytology Market: Maintains a top market share in the domestic market through the development and production of PATHPLORER LBC System diagnostic equipment and reagents.
- High Specialization in Early Cervical Cancer Diagnosis: Expertise in enhancing diagnostic accuracy by utilizing p16INK4a and Ki-67 protein dual staining technology for detecting cellular changes in cervical pre-cancerous lesions. Anticipates benefits from WHO's recommendations and revised guidelines for early cervical cancer diagnosis.High Specialization in Early Cervical Cancer Diagnosis: Expertise in enhancing diagnostic accuracy by utilizing p16INK4a and Ki-67 protein dual staining technology for detecting cellular changes in cervical pre-cancerous lesions. Anticipates benefits from WHO's recommendations and revised guidelines for early cervical cancer diagnosis.
- Development of Next-Generation Self-Sampling Diagnostic Products: Pioneering new markets with the development of the patient-friendly 'Earlypap' self-sampling brush for cervical cancer cells, expanding its potential use in medically underserved areas as a future growth engine.Development of Next-Generation Self-Sampling Diagnostic Products: Pioneering new markets with the development of the patient-friendly 'Earlypap' self-sampling brush for cervical cancer cells, expanding its potential use in medically underserved areas as a future growth engine.
- Target Industrie
- Medical Device Industry: Manufacturing and sales of cancer diagnostic equipment and related consumables.Medical Device Industry: Manufacturing and sales of cancer diagnostic equipment and related consumables.
- In-vitro Diagnostics Industry: Providing early cancer diagnosis solutions using liquid-based cytology (LBC) technology.In-vitro Diagnostics Industry: Providing early cancer diagnosis solutions using liquid-based cytology (LBC) technology.
- Clinical Pathology Field: Supplying diagnostic equipment and reagents for cervical cancer and various cytopathology examinations.Clinical Pathology Field: Supplying diagnostic equipment and reagents for cervical cancer and various cytopathology examinations.
- Major Markets
- Japan, ThailandJapan, Thailand
- Russia, Portugal, GermanyRussia, Portugal, Germany
- United States (FDA approval and market entry in progress)United States (FDA approval and market entry in progress)
- Australia (preparing for global market entry)Australia (preparing for global market entry)
- Certifications/Patents
- Patent registration for a specimen implantation device using the Blowing Technology method (2013). Acquired domestic and international patents in Korea, Japan, and the United States.Patent registration for a specimen implantation device using the Blowing Technology method (2013). Acquired domestic and international patents in Korea, Japan, and the United States.
- ISO 13485 certification (2017).ISO 13485 certification (2017).
- European CE certification for Cellprep (PATHPLORER) LBC equipment (including diagnostic reagent kits) (2018).European CE certification for Cellprep (PATHPLORER) LBC equipment (including diagnostic reagent kits) (2018).
- PSCI (Pharmaceutical Supply Chain Initiative) audit acquisition (TUV Rheinland) (2020).PSCI (Pharmaceutical Supply Chain Initiative) audit acquisition (TUV Rheinland) (2020).
- US FDA notification for diagnostic reagent kits (solution, filter, slide) (2015).US FDA notification for diagnostic reagent kits (solution, filter, slide) (2015).
- South Korean MFDS approval (late 2024) and US FDA clearance (March 2025) for the 'Earlypap' cervical cancer cell self-sampling brush. European CE certification process underway.South Korean MFDS approval (late 2024) and US FDA clearance (March 2025) for the 'Earlypap' cervical cancer cell self-sampling brush. European CE certification process underway.
- Roche's CINtec PLUS dual-stain test is the only test with US FDA and European CE approval for classifying HPV-positive patients.Roche's CINtec PLUS dual-stain test is the only test with US FDA and European CE approval for classifying HPV-positive patients.
Introduction
Location
24-4 Achasan-ro 5-gil, Seongdong-gu, Seoul, South Korea
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