We’re ready to support you. Leave us a message and we’ll get in contact.
IVD Assay development
Future Diagnostics has decades of experience in IVD assay development, creating IVD products, IVD assays and diagnostic assays for the global in vitro diagnostics market. Our team of experts manages the entire assay development process, from proof of concept to final product. We deliver high-quality IVD tests that meet client needs and comply with ISO 13485 and FDA regulations, resulting in fully validated products ready for market approval.
IVD product development possibilities by Future
Blood tests are essential for detecting diseases and deficiencies—from Vitamin D to HIV, diabetes, and heart attacks. The devices for these tests can’t measure biomarkers on their own; they need expert IVD development.
At Future Diagnostics, we determine the right reagents, protocols, and documentation to ensure accurate results and a smooth market introduction. We create the optimal starting point—so your device and its users can do the rest.
Why choose Future Diagnostics for IVD assay development
We turn complex IVD challenges into market-ready solutions. Our expertise, commitment to quality, and regulatory know-how ensure your product reaches the market quickly, efficiently, and fully compliant.
Let's connect
Partner with Future Diagnostics and get a clear, proven development process, feasibility testing before you commit, full compliance with regulatory standards & access to our trusted network of suppliers.
Our portfolio in the field of IVD product development
Many years of experience have led to a large number of successes. Through our clients we have introduced numerous IVD tests to the market. The end products developed by our IVD test development facility help clinicians to diagnose and monitor diseases and deficiencies. We strive to improve the quality of life for patients, not only for now but also in the future.
Our experience across different disease areas:
Heart and vascular disease
Infectious diseases
Autoimmune diseases
Bone metabolic diseases
Oncology
Endocrinology
Anemia
Diabetes
The full list of IVD tests
Of course we can speak highly about the many different processes of IVD test development which have led over the years to highly useful end products for the medical diagnostic market. But it is the facts that speak volumes. Here’s the full list of IVD realized end products.
IVD product development; how we model end products
At Future Diagnostics, we work exclusively on request—developing tests based on your specific needs rather than investing in new products ourselves. We begin with an open conversation to understand your objectives, leading to a clearly defined project scope and strong collaboration.
Once goals are set, we run a feasibility study to check the availability of critical materials, assess technical achievability, and determine realistic timelines and budgets. This transparent approach ensures you know exactly what’s possible before committing to full development.
We partner only with trusted suppliers—such as specialized antibody producers—to guarantee quality at every stage. Our proven step-by-step process has delivered consistent results for clients worldwide, helping them bring reliable IVD products to market with confidence.
Case study: The fast route to the market
Future Diagnostics assists where necessary, be it large parties with extensive IVD devices or start-ups with limited manpower. Our IVD product development is based on one principle, which guarantees an efficient yet extremely precise IVD test development. Without exception, we return everything we research and develop back to our clients. That is our promise to you.
FDx quickly understood our needs, tailored a fitting proposal, and delivered through open communication and a skilled team. We highly recommend them for IVD development and validation.
Experience that drives results
With nearly 25 years in IVD development, we know our way around countless clinical chemistry analyzers and technologies—allowing us to start fast and work efficiently.
Our clients rely on us for high-quality service and validated tests, guaranteed by skilled professionals, premium materials, and a rigorous quality management system. We strive for minimal waste, maximum results, and flawless execution—because our commitment is key to bringing your product to market.
Trusted by Leading Biotech and IVD Companies
IVD assay development in times of IVDR
FACT: in Europe IVDR will be the new reality. This calls for a serious set of changes and a thorough preparation. IVD test will need to meet the new requirements or they will simply not be approved for market introduction. Future Diagnostics offers analytical performance studies. We already incorporate the requirements for the regulations in our IVD product development to ensure our developed products meet these regulations. And of course on request, we can subject existing tests to the specific part of the test procedures so that they are ready to meet the new standard of IVDR in 2022.
Frequently asked questions
What types of assay development and diagnostic services do you offer?
We offer a wide range of assay development and diagnostic services covering every stage from concept to validated IVD product. Our work includes full-service support for ivd assay development, custom assay development, optimization of diagnostic assays, and complete ivd development for in vitro diagnostics. We design assays for use in clinical laboratories, laboratory testing workflows, and medical devices, supported by strong technical expertise and global standards. Our services include feasibility studies, assay performance optimization, validation with clinical samples, risk analysis, quality assurance, quality control, regulatory affairs guidance, and preparation for regulatory approval or fda approval. We also support product development, intended use definition, good manufacturing practices, good laboratory practices, and strategic planning. After product launch, we help monitor product performance through continuous monitoring and post market surveillance to ensure compliance, reliability, and high patient outcomes throughout the full lifecycle of your in vitro diagnostic product.
Can Future Diagnostics help with IVDR compliance for IVD assays?
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.
What additional services do you offer besides assay development?
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.
How many IVD assays has Future Diagnostics developed?
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.
What is in vitro assay development?
IVD assay development is the structured creation and optimization of ivd assays used in in vitro diagnostics. It involves defining the assay development process, selecting suitable raw materials, ensuring strong assay performance, and validating results in clinical samples. These diagnostic assays play a critical role in early detection, accurate diagnosis, and improving patient outcomes across modern healthcare.
How does assay development differ from general laboratory testing?
General laboratory testing focuses on running established assays, while assay development involves designing, optimizing, and validating a new method. This requires deep technical expertise, strong quality assurance, rigorous quality control, and adherence to global standards.
Let’s join forces
Future Diagnostics wants to be your partner in IVD product development and we are able to do this with different detection technologies. We are a transparant partner, employing only the highest motivated professionals, and always strives for the highest standard in precision working. No matter whether you are running a multinational business or a start-up with limited access to manpower: Future Diagnostics is your ultimate working partner!