Who We Are
Since our founding in 1997 in Wijchen, the Netherlands, Future Diagnostics has been a trusted partner in in vitro diagnostic (IVD) immunoassay development. With over 27 years of experience, our team of 25–30 highly skilled professionals invent, create, optimize and validate immunoassays—ranging from manual ELISA’s to multiplex microarrays and point-of-care platforms—delivered to clients across biotech, pharma, and IVD sectors worldwide.
Our mission is simple: deliver accurate biomarker detection to enable better healthcare. With ISO 13485 certification and decades of experience, we combine quality, integrity, and flexibility to create diagnostics that make a real difference.
Because we do it for our partners, we do it for the best possible healthcare.
What our clients gain from Working with Us
Working with FDX means gaining more than a service provider — you gain a partner who acts as an extension of your team. Our clients benefit from shorter time-to-market, early risk identification, and built-in regulatory compliance. Every project is supported with clear communication, milestone-driven planning, and audit-ready documentation, giving you total confidence from feasibility to commercialization. The ultimate result: your innovations reach patients faster, with lower risk and higher impact.
Mission, Vision & Core Values
Mission
A world in which our clients are empowered to support medical professionals around the globe in their daily pursuit of the best possible healthcare for everyone.
Vision
A world empowered by reliable biomarker testing—leading to timely and effective healthcare interventions.
Values
Open & Transparent: We build trust through accuracy and transparency.
Integrity: We offer a trustworthy and secure environment where confidentiality, and mutual respect guide both our internal culture and our collaborations with clients.
Driven: Every project receives our full focus. Our people are passionate about test development and have a “can-do” mentality. We do everything in our power to ensure the journey we embark on together leads to the best possible results. Together, we strive for the best and try to learn from our mistakes time and again.
Flexibility: Adaptive, client-centric, and always forward-moving. The famous saying “Biomarkers have a mind of their own”—a well-known one within the Future Diagnostics family—explains why IVD test developments can be complex. That’s why we always work
with a step-by-step plan.
Quality Standards & Compliance
Quality isn’t just our promise—it’s our foundation:
ISO 13485:2016 certified – Our complete quality management system ensures your IVD assay development meets the highest global standards, giving you confidence in reliability, compliance, and patient safety.
Regulatory readiness – With CLSI, IVDR, and FDA requirements embedded into our development process (including full documentation and Design History Files), you save time, reduce risk, and move to market faster.
Premium materials & methodologies – By using only top-grade reagents from top-grade suppliers and advanced platforms like our proprietary microSCY™ for robust antibody screening, we help you achieve superior assay performance and reproducibility.
Ongoing validation – Regular audits and recertifications of our labs, instruments, and staff ensure consistent excellence, so you can rely on us as a longterm partner for innovation and quality.
Close Network
Collaborations lie at the heart of our innovation. We work closely with top experts and biotech companies from our field. Because of our strong network we can also assist with IVDR regulatory compliance support, human biospecimens collection, antibody generation and special molecule production.
Our Development Process
We follow a five-phase New Product Development Process (NPDP) to guarantee predictable, compliant, and high-quality outcomes:
1. Discovery & Feasibility – Evaluate reagents, biomarkers, and assay formats.
2. Design & Optimization – Refine parameters, signal strength, and matrix compatibility.
3. Verification –Implement analytical testing aligned with CLSI guidelines.
4. Validation – Produce performance data needed for regulatory approval.
5. Manufacturing (at FDX or Transfer) – Provide SOPs, produce pilot batches, and quality control for scale-up.
Throughout, clients receive real-time project updates via SharePoint, with milestones tracked for transparency.
Join Us on Our Journey
Whether you’re a startup or established market player, Future Diagnostics is ready to partner in developing high-impact immunoassays. Let’s innovate together.
