At Future Diagnostics, we are industry leaders in plate-based immunoassay development, specializing in custom, plate-based assays that transform biomarker concepts into robust diagnostic solutions.
Our dedicated team provides comprehensive development and optimization for plate-based immunoassays across diverse disease areas, including cardiovascular, infectious, autoimmune, oncology, and hormonal testing. We develop regulatory-compliant assays that meet FDA, IVDR requirements, using applicable CLSI standards for performance validation, ensuring state-of-the-art product design.
We turn complex Immunoassay Development into market-ready solutions. Our expertise, commitment to quality, and regulatory know-how ensure your product reaches the market quickly, efficiently, and fully compliant.
Immunoassay development is a key part of our IVD work, and the outcomes speak for themselves. Below you can explore the full range of IVD products we have successfully developed across our platforms.
Our plate-based immunoassay development services are ideal for:
Our proven development methodology ensures successful outcomes:
What types of immunoassays does Future Diagnostics develop?
We develop a broad range of immunoassays, including ELISA (direct, indirect, sandwich, competitive ELISA), Chemiluminescence Immunoassay (CLIA), Point of Care, lateral flow, microarray, and multiplex assays. These are customized for applications in cardiology, oncology, fertility, infectious diseases, autoimmunity, and other disease areas. Whether for diagnostic automated platforms, point-of-care devices, or manual research tools, our ISO 13485-compliant services cover the full development spectrum.
Do you offer custom development for new or complex immunoassays?
Yes. We provide full custom development for both new and existing immunoassays, including feasibility testing, assay design, optimization, and performance evaluation. Our team tailors every step to your specific biomarker, platform, and end-user requirements, ensuring a robust and scalable solution.
How does your contract model work for immunoassay development projects?
Projects are executed under a clear contract that defines scope, timelines, deliverables, intellectual property, and budget. This structure ensures transparency from the start and allows your project to progress efficiently while maintaining flexibility for scientific or technical adjustments when needed.
What is included in your development and validation process for immunoassays?
Our development and validation process covers all critical steps: reagent selection, assay optimization, analytical validation, verification with clinical samples, documentation, and transfer into production. Each phase is performed under strict quality standards to ensure accuracy, reproducibility, and regulatory readiness.
Why should our company partner with you for immunoassay development services?
Your company benefits from a highly experienced development team, access to specialized lab infrastructure, and a proven workflow that minimizes risk and accelerates progress. We combine scientific expertise with strong project management to deliver reliable immunoassays that are ready for scale-up, regulatory review, and commercial use.
Future Diagnostics assists where necessary, be it large parties with extensive IVD devices or start-ups with limited manpower. Our IVD product development is based on one principle, which guarantees an efficient yet extremely precise IVD test development. Without exception, we return everything we develop back to our clients. That is our promise to you. Contact our development team to discuss your biomarker detection requirements and accelerate your path to market.
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