From concept to clinical impact
At Future Diagnostics (FDX), we help biotech, pharma, and diagnostic companies bring innovative tests to life—faster and smarter. With 25+ years of expertise in IVD assay development services and immunoassay design, we turn complex biomarker challenges into reliable diagnostic solutions. From idea to market-ready product, our mission is straightforward: accelerate your success with precision , compliance, and efficiency.
What We Do (Why It Matters)
FDX delivers end-to-end IVD assay development services—covering every development stage from proof-of-concept to validation to pilot production, and eventually commercialization.
What You Gain from Partnering with Us
When you work with FDX you don’t just outsource development, you gain a partner embedded in your team.
- Speed to market, through early feasibility and right-first-time development, streamlined processes that save valuable time.
- Risk reduction, early identification of technical challenges and by embedding ISO 13485, FDA, and IVDR/CE requirements from day one.
- Decades of (immuno)assay experience
- Confidence & clarity, transparent communication and milestone-driven progress.
Download our complete assay portfolio
Why Choose FDX
Decades of experience. With over 28 years in trusted IVD immunoassay development services, our senior team understands the challenges and nuances of building assays that perform in real-world conditions. You benefit from fewer setbacks, and proven development pathways that have already delivered hundreds of successful assays worldwide.
Unique technology edge. Our proprietary micro-SCY™ platform delivers unmatched antibody screening insights. Faster convergence on the best antibody–antigen match, reduced trial-and-error, and higher assay performance — ultimately shortening your path to a robust commercial product.
Agile process, measurable results. We track project KPIs across quality, budget, and delivery timelines. No surprises, no hidden costs. You always know where your project stands and can make informed, data-driven decisions at each milestone.
Regulatory-ready from the start. We seamlessly integrate ISO 13485, FDA, and IVDR requirements into every stage of development. You avoid costly rework, save valuable time, and move faster toward approvals.
Where We Excel
Future Diagnostics is your ideal partner when you need expertise in advancing your diagnostics:
- Immunoassay development and optimization — We build robust assays from proof-of-concept to regulatory-grade assay, or improve sensitivity, reduce variability, and extend shelf-life on existing assays, giving you fewer failed runs, more reliable data, lower costs, and better long-term product stability.
- Validation & Verification — Future Diagnostics combines deep assay expertise, ISO 13485-aligned quality systems and CLSI-based validation approaches to produce the objective, regulator-grade evidence your product needs.
- Tech transfer and scale-up — We prepare products for robust manufacturing, ensuring a smooth path from lab bench to production floor with scalability and consistency.
- Novel biomarker assays and pharma-related IVDs & CDx — We translate biomarker discoveries into clinically relevant, regulatory-ready assays, enabling earlier go/no-go decisions and faster innovation toward precision medicine.
How We Work
Our structured yet flexible process ensures clarity and results:
- Discover & Assess: Define biomarker and goals, run feasibility studies.
- Design & Optimize: Choose assay format, refine sensitivity & specificity.
- Validate & Verify: Confirm performance against IVDR, FDA, and CLSI standards.
- Transfer & Scale: Develop SOPs, batch records, and support reliable scale-up.
- Support & Document: Deliver Design History Files and continuous project updates.
Ready to Accelerate Your IVD Assay Development?
With Future Diagnostics, you gain a partner who combines innovation, compliance, and technical expertise — ensuring your assay reaches the market faster, stronger, and fully regulatory-ready.