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.
Partner with Future Diagnostics and get a clear, proven development process, feasibility testing before you commit, full compliance with regulatory standards & access to our trusted network of suppliers.
Our plate-based immunoassay development services are ideal for:
Of course we can speak highly about the many different processes of IVD test development which have led over the years to highly useful end products for the medical diagnostic market. But it is the facts that speak volumes. Here’s the full list of IVD realized end products.
Our proven development methodology ensures successful outcomes:
Does Future Diagnostics develop multiplex assay panels?
Absolutely. We design, develop and validate multiplex immunoassays using platforms such as microarrays and fluorescence detection systems. Our team ensures that the product design meets requirements in respect to clinical relevance, sensitivity, and robustness from early development through validation.
How does Future Diagnostics support IVD assay development from concept to market?
Our proven New Product Development Process (NPDP) includes:
This structured approach ensures compliance with ISO 13485, IVDR (EU), and FDA regulations.
What additional services do you offer besides assay development?
In addition to full assay development, we offer:
What is included in your assay development, optimization and validation services?
We offer complete assay development, optimization & validation, including:
Analytical performance evaluation studies based on applicable CLSI standards: sensitivity/specificity, precision, dection capability (LoB/LoD/LoQ, linearity, method comparison, matrix equivalence various stability studies, and more.
Our team helps you achieve consistent, reproducible performance needed for regulatory approval.
What types of assay development and diagnostic services do you offer?
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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.
