Immunoassay development
At Biocult, we are industry leaders in plate-based immunoassay development, specializing in custom, plate-based assays that transform biomarker concepts into robust diagnostic solutions.
Expertise in plate-based immunoassays
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.
Why choose Biocult for immunoassay development
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 results
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 key capabilities include:
- ELISA development (colorimetric, fluorescent, chemiluminescent)
- Manual CLIA-based immunoassay
- Custom antibody/antigen-based biomarker assays
- Microplate immunoassay
- Assay optimization and verification
- Technical (Analytical) validation
Why choose our immunoassay development services?
Trusted expertise
Over 27 years developing innovative diagnostic assays for global partners
Regulatory excellence
Compliance with ISO 13485, IVDR, FDA, and CLSI protocols
Agile development process
Two experts (technical specialist & project manager) ensure quality, compliance, clear planning, and efficient progress.
Customized solutions
Tailored methodologies for novel biomarkers and clinical applications
Collaborative approach
Partner-focused mindset with transparent communication at every step
Applications of plate-based Immunoassays
Our plate-based immunoassay development services support a wide range of organizations, from research institutions developing novel biomarker assays to medical device manufacturers bringing new IVD products to market. We also partner with biopharma companies to develop companion diagnostics that support targeted therapies and personalized medicine approaches.
Comprehensive development process
Our proven development methodology is designed to deliver reliable, high-performance immunoassays from concept to market. The process begins with feasibility assessment and biomarker validation, followed by antibody selection and optimization to identify the most effective assay components. We then develop and optimize the assay format and plate coating conditions to ensure robust performance. Comprehensive validation is conducted to confirm precision, accuracy, and sensitivity, while stability studies and shelf-life testing ensure long-term reliability and regulatory readiness.
Frequently asked questions
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.
Click here to download our assay & platform portfolio
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.
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.
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.
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.
Ready to develop your next plate-based immunoassay?
Biocult 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.