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.

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We partner with global pharmaceutical, biotech, and in vitro diagnostic (IVD) companies. Our clients range from startups needing assay prototypes to established corporations requiring fully validated, regulatory-compliant IVD products.

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Our proven New Product Development Process (NPDP) includes:

• Proof of concept and feasibility studies
• Assay design and optimization
• Design verification and validation
• Full documentation for your Design History File (DHF)
• Technology transfer to manufacturing & commercialization

This structured approach ensures compliance with ISO 13485, IVDR (EU), and FDA regulations.

Yes. We support companies preparing for IVDR (In Vitro Diagnostic Regulation) by performing analytical performance validation studies, collecting the required samples, identifying both documentation and performance gaps, and preparing regulatory files. We follow the latest CLSI guidelines and IVDR Annex I & II requirements, streamlining your path to CE marking.

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.

Yes. Our facility in Wijchen, the Netherlands operates under ISO 13485:2016. We also meet requirements for IVDR, and other international standards, ensuring global compliance for your product.

We offer complete assay development, optimization & validation, including:

• Raw material performance screening using our proprietary micro-SCY™ technology (antibodies, antigens, conjugates)
• Sensitivity (detection capability) improvement
• Matrix effect evaluation
• Reagent stability improvent (either as ready-to-use or lyophilized)

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.

We follow an agile project management approach, using KPIs to track budget, quality, and time. Clients receive regular updates via our secure SharePoint portal and frequent project meetings. Transparent communication and clear milestones help minimize risks and ensure predictable timelines.

We’ve contributed to the development of over 150 IVD assays for global markets. These include both RUO (Research Use Only) and CE-IVD products, across diverse platforms—from simple colorimetric ELISAs to fully automated CLIA systems and point-of-care tests.

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In addition to full assay development, we offer:

• Antibody and antigen conjugation to a custom label
• Microarray spotting and printing
• Prototype reagent manufacturing
• Analytical performance testing
• Lyophilization
• Bead-coating
• Plate-based immunoassay development services
• We also assist with tech transfer and scale-up for commercial manufacturing.

Yes, we provide early-stage feasibility and proof-of-concept services to help clients determine technical viability before full-scale development. This includes material sourcing, small-scale reagent testing, signal optimization, and preliminary performance assessments—ideal for startups and pharma R&D teams exploring new biomarkers or assay formats.

Absolutely. Once your assay is validated, we manage a smooth technology transfer from FDx to our internal manufacturing department or to external manufacturing partners. This includes SOPs, batch records, pilot production, and scalability assessment to ensure consistent performance at commercial scale.

Lead times are optimized for speed, typically ranging from 3 to 6 weeks depending on product complexity and specific requirements . We prioritize rapid turnaround for pilot studies.

We specialize in small- to medium scale production with flexible batch sizes tailored to early-stage development, clinical studies, and initial commercialization efforts and market penetration. This enables cost-effective testing and iteration without large upfront investments.

Every batch includes comprehensive documentation: batch records, QC results, and a Certificate of Analysis (CoA), all aligned with our ISO 13485 certification.

Yes. Our logistics support both cold chain and ambient shipping to ensure the integrity of freeze-dried reagents and other components. We partner with you to select the optimal shipping method based on stability data.