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Innovative Diagnostics for Chronic Kidney Disease: Hycult Biotech's Complement Biomarker Assay
Hycult Biotech, a family-owned Dutch company with nearly three decades of expertise in antibody and assay development, is collaborating with the Microfluidics Innovation Hub (MIH) to revolutionize the diagnosis and monitoring of chronic kidney disease (CKD). Their focus is on creating a non-invasive, multiplex point-of-care (PoC) assay that detects complement activation markers, providing a rapid and reliable alternative to traditional kidney biopsies.
Understanding Hycult Biotech's Mission
Hycult Biotech has been at the forefront of immunology research, developing high-quality antibodies, proteins, and ELISA kits used worldwide in academia and pharmaceutical industries. Specializing in complement and innate immunity research, Hycult Biotech is committed to bridging the gap between advanced scientific research and practical diagnostic tools. Their subsidiary, Biocult, extends this expertise to offer services in monoclonal antibody and assay design to startups and diagnostic companies.
The Diagnostic Challenge
Chronic kidney disease often progresses silently, making early detection difficult. Traditional diagnostics rely on invasive kidney biopsies coupled with immunohistochemical staining, which are not only stressful and time-consuming but also lack sensitivity. Hycult Biotech aims to address this significant unmet need by developing a non-invasive diagnostic test using blood or urine samples to facilitate early detection and monitoring of CKD through complement analysis.
Hycult Biotech's Innovative Approach
Hycult Biotech is developing a multiplex PoC assay integrated into the GENSPEED® xPOC microfluidic platform. This assay will measure multiple complement activation markers from a single sample, offering a rapid, reliable, and user-friendly diagnostic tool.
Key Components of the Complement Biomarker Assay:
Microfluidic Chip: Utilizes a disposable chip designed to detect multiple biomarkers in a single test.
CaptSure™ Technology: Enables precise antibody binding and detection for multiplexed assays.
Rapid Analysis: Provides results within 20 minutes, facilitating timely clinical decisions.
Hycult Biotech's project aims to revolutionize CKD diagnostics by addressing several key challenges:
Early Detection: Enable earlier diagnosis of CKD to prevent irreversible kidney damage.
Improved Monitoring: Provide a reliable tool for ongoing disease and therapy monitoring.
Enhanced Patient Care: Reduce the need for invasive biopsies, thus improving patient comfort and reducing healthcare costs.
Scalable Production: Transition to high-volume manufacturing methods to meet market demand and reduce production costs.
Goal
Functional Multiplex Assay: Create a multiplex PoC test that accurately measures C3, C3d, and TCC complement markers.
Cost-Effective Manufacturing: Transition from injection molding to roll-to-roll (R2R) manufacturing to reduce costs and scale up production.
Solution
HAssay Development: Utilize GENSPEED’s platform to develop and validate the multiplex assay.
Manufacturing Transition: Employ R2R UV nanoimprint lithography and extrusion coating techniques to produce high-quality microfluidic chips.
Requirements
High Sensitivity and Specificity: The PoC test must achieve sensitivity and specificity comparable to current ELISA-based assays.
Fast Turnaround Time: Results must be available within 30 minutes to facilitate timely clinical decisions.
Compatibility with Blood Samples: The test should be functional with small blood volumes obtained via finger prick.
Scalable Production: Implement R2R manufacturing to meet production volume demands and reduce unit costs.
The Role of the #MIHfamily
GENSPEED Biotech GmbH (GSB): Leads the assay development and system integration on their existing PoC platform.
JOANNEUM RESEARCH Forschungsgesellschaft mbH (JR): Provides expertise in roll-to-roll (R2R) UV nanoimprint lithography for scalable chip production.
Inmold A/S (INM): Specializes in R2R extrusion coating and structuring for the microfluidic chip.
Micronit b.v. (MIC): Handles the backend services including bonding and singulation of the chips.
micro resist technology GmbH (MRT): Supplies the UV-NIL resins and ensures the stability and functionality of the coating.
Partners Involved
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Services and Technologies
Together with the #MIHfamily, Hycult Biotech is driving innovation in CKD diagnostics. This collaboration combines cutting-edge technology and collective expertise to bring a new level of precision and efficiency to complement analysis and patient care.
This project has received funding from the European Union’s HORIZON 2020 research & innovation programme under grant agreement no. 862092.
