Lepzi Biotechnology Ltd.,based in Richmond, Canada.Our team brings together professionals with extensive experience in design and development of point-of-care medical devices, from early-stage prototyping and reagent development to implementation of specialized manufacturing and quality control processes.
Lepzi Diagnostika Ltd., based in Sofia, Bulgaria.We are innovative company working in the field of high-performance technologies for medical diagnostics and medical care. Our team consists of professionals with extensive experience in the design and development of medical devices, prototypes and reagents to the application of specialized processes for production and quality control. Lepzi Diagnostika provides an advanced platform for immunoassay that allows a rapid flow of diagnostic information for improvement of the medical care.
Our Quality Management System is ISO 13485:2016 registered and it creates a reliable framework for development and manufacture of critical assay components for the LEPZI platform.
Lepzi has got CE marking. As the manufacturer,Lepzi is now responsible for the design, manufacture and control of the registered medical device (s) and its assessment in accordance with the essential requirements of the Medical Devices Act and its implementing acts, which introduce Directive 98/79 / EC and other relevant regulations.
The LEPZI immunofluorescence platform developed by Lepzi employs a revolutionary design to provide fast and reliable measurement of specific analytes in human whole blood.
All it takes to run a test is a simple transfer of blood or plasma specimen to the LEPZI test cartridge followed by cartridge scanning inside a portable fluorescence reader.
No sample dilution! No liquid reagents!
Our portfolio of LEPZI tests includes biomarkers for congestive heart failure, acute myocardial infraction, kidney failure, pulmonary embolism and preeclampsia.
New products in development include multiplex LEPZI tests for simultaneous measurement of multiple analytes in a single test cartridge.
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The utilization of LEPZI immunochromatography platform design allows for quick development of new LEPZI tests for a wide range of medical conditions.
Rapid,Accurate and Convenient.
Developed a variety of product portfolios including tests of pregnancy and fertility , tumor marker,infectious disease,inflammation,drug of abuse, etc.
New products in development include multiplex LEPZI tests for detection of multiple biomarkers in a single test device cartridge.
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Our philosophy is that the challenges faced by the healthcare providers worldwide can only be solved by bringing together partners with a diverse expertise in biomarker discovery, clinical research, product development, manufacturing and commercialization.
LEPZI assay platform licencing to facilitate the introduction of novel biomarkers for medical diagnostics.
Distribution partnerships to facilitate the introduction of reliable and cost- effective diagnostic solutions in different parts of the world.
Cooperation in building global manufacturing capabilities to address the unique demands of each market.