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Wijchen, GE NetherlandsAt Future Diagnostics, we specialize in developing high-quality, high sensitive in vitro diagnostic (IVD) Immuo assays tailored to meet the evolving needs of the medical device and biopharma industries. As experienced laboratory professionals, we support global clients with the development of biomarker assays, IVD tests, and custom diagnostic products—from initial concept to market-ready solution. With a strong foundation in ISO 13485- and FDA-compliant development, we are a trusted partner to pharmaceutical, IVD and biotech companies worldwide. Whether you need assay design, assay validation, or manufacturing support, we act as an extension of your team—bringing innovation, expertise, speed and precision to every step of the process. Our solutions are designed to be scalable, robust, and compliant with global regulatory standards, including IVDR, FDA, and CE marking requirements. 1. IVD Test & Product Development Complete development of in vitro diagnostic tests, including assay design, prototyping, optimization, and clinical validation across multiple disease areas. All processes meet ISO 13485 and FDA regulatory standards. 2. Biomarker Assay Development for Biopharma We collaborate with biopharma clients to develop high-sensitivity biomarker assays that support drug development, companion diagnostics, and personalized medicine. 3. Manufacturing Services: - Assembly of full immunoassays (e.g. ELISA, EIA, CLIA) - Reagents (e.g. buffers) - Custom Conjugation - Small scale bead coating - Lyophilization of kit components, also accuspheres - Product filling, capping and labeling
Nieuweweg 279 Wijchen, 6603 BN The NetherlandsAt Future Diagnostics, we specialize in developing high-quality, high sensitive in vitro diagnostic (IVD) Immuo assays tailored to meet the evolving needs of the medical device and biopharma industries. As experienced laboratory professionals, we support global clients with the development of biomarker assays, IVD tests, and custom diagnostic products—from initial concept to market-ready solution. With a strong foundation in ISO 13485- and FDA-compliant development, we are a trusted partner to pharmaceutical, IVD and biotech companies worldwide. Whether you need assay design, assay validation, or manufacturing support, we act as an extension of your team—bringing innovation, expertise, speed and precision to every step of the process. Our solutions are designed to be scalable, robust, and compliant with global regulatory standards, including IVDR, FDA, and CE marking requirements. 1. IVD Test & Product Development Complete development of in vitro diagnostic tests, including assay design, prototyping, optimization, and clinical validation across multiple disease areas. All processes meet ISO 13485 and FDA regulatory standards. 2. Biomarker Assay Development for Biopharma We collaborate with biopharma clients to develop high-sensitivity biomarker assays that support drug development, companion diagnostics, and personalized medicine. 3. Manufacturing Services: - Assembly of full immunoassays (e.g. ELISA, EIA, CLIA) - Reagents (e.g. buffers) - Custom Conjugation - Small scale bead coating - Lyophilization of kit components, also accuspheres - Product filling, capping and labeling
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