Biomarker Assay Development for Biopharma
In the era of precision medicine, in vitro diagnostics (IVDs) are essential tools for unlocking patient insights and driving therapeutic success. From early disease detection and prognosis to evaluating drug efficacy and guiding treatment decisions, pharma-related IVDs — such as treatment monitoring tests, complementary diagnostics, and companion diagnostics — are redefining healthcare efficiency and effectiveness.
At Future Diagnostics, we combine decades of immunoassay and IVD expertise with a proven track record in biomarker translation to deliver high-value, regulatory-ready diagnostic solutions. By partnering with biopharma companies worldwide, we transform the most complex technical challenges into impactful biomarker programs—improving not only the success of your therapeutic pipeline but also the diagnostic journey for patients.
Our capabilities
At Future Diagnostics, we support biopharma partners in transforming promising biomarkers into reliable, validated assays. Our expertise spans the full development cycle—from feasibility and optimization to verification and transfer to clinical platforms. With decades of experience and state-of-the-art facilities, we ensure every assay meets the highest standards for accuracy, reproducibility, and regulatory compliance. Together, we accelerate the path from discovery to patient impact.
De-novo Assay Development
From concept to clinical-grade, we develop fit-for-purpose immunoassays across multiple platforms—tailored to each application and stage of development. Our expertise spans the full range of immunoassay platforms, from plate-based assay to novel detection devices, and related formats such as enzymatic assays. We manage the full process—from sourcing critical raw materials to delivering IVD-grade assays ready for market.
Assay Optimization
Struggling internally with assay development challenges? Leverage our decades of know-how to improve your assay’s specificity, reproducibility, or robustness—ensuring reliable results that meet regulatory and clinical demands.
Platform Migration & Scale-up
We seamlessly transfer assays between platforms while maintaining or enhancing performance. Whether transitioning manual assays to automated analyzers or migrating RUO platforms (MSD, Luminex) into validated IVD-ready systems, we ensure smooth scalability and readiness for clinical deployment.
Verification & Validation for Pharma-related IVDs
From treatment monitoring to companion and complementary diagnostics, we provide full verification and validation—aligned with global regulatory requirements—to move your biomarker confidently into the IVD space.
Manufacturing & Commercialization
With flexible contract manufacturing, we support immunoassay batch production for validation studies or initial launches. For large-scale rollout, our strong global partnerships with leading IVD providers offer the infrastructure, reach, and commercialization strategies to maximize your assay’s market impact.
Fit-for-purpose Immunoassay Development Across Clinical Stages
Every stage of a clinical program demands assays that are robust, reliable, and fit-for-purpose. At Future Diagnostics, we support pharma and biotech partners with immunoassay solutions that evolve seamlessly with the needs of their drug and biomarker development journey.
From early assay set-ups, pilots, and proof-of-concepts to research-use-only (RUO) formats, we deliver exploratory assays that generate meaningful insights at the discovery stage. As programs mature, we transition these assays into validated clinical biomarker assays that withstand regulatory scrutiny and deliver reproducible data for decision-making.
Our expertise also covers the critical bridge from RUO to IVD, ensuring smooth migration into regulatory-grade, commercially deployable diagnostics. Whether it’s moving from exploratory biomarker discovery to clinical validation, or transforming RUO assays into full companion or complementary diagnostics, we provide the technical and regulatory know-how to de-risk the process.
By combining deep immunoassay expertise, flexible technology platforms, and regulatory-ready processes, Future Diagnostics ensures that your assays not only meet the scientific demands of each stage, but also align with the long-term strategy of bringing biomarker-driven IVDs to market.
From Biomarker to Market
Looking to bring the immunoassays supporting your drug development programs to market? Through innovative partnership models, Future Diagnostics provides end-to-end services that transform exploratory biomarker assays into market-ready IVDs. Whether you need early-stage support, validation, or a partner for full commercialization, our global network enables a seamless transition from lab bench to patient bedside.
Our comprehensive offering includes:
- Assay development
- Analytical and clinical validation
- Contract & legal manufacturing
- Regulatory support (CE-IVD, FDA, ISO 13485:2016 compliance)
- Commercialization strategy & distribution through trusted global partners
This integrated approach combines the flexibility and focus of a small, specialized CRO with the scalability of established IVD leaders—a unique blend that accelerates timelines and enhances success.
What sets Future Diagnostics apart
Let’s build the future of precision medicine — together
Contact Future Diagnostics today to explore how we can support your biomarker and pharma-related IVD programs.
