Future Diagnostics Solutions

Future Diagnostics offers in vitro diagnostic (IVD) immunoassay development services for:

• Immunoassay Analyzers
• ELISA
• Microfluidic Point-of-Care Tests
• Multiplex Micro-Arrays

Whether you need highly specialized knowledge or manpower to bring your concept to market, we are your trusted independent partner for the development of many different types of immunoassays, with different technologies, either manually or automated.

Apart from developing complete IVD immunoassays, we also offer verification & validation, analytical performance services, micro-array spotting, or antibody/antigen conjugations.

We can develop a Companion Diagnostics for your drug. What we do, in essence, is choose an assay format, collect the right components, and put together a good working protocol. Each assay format requires different numbers and varieties of components and offers a different level of detection capability, specificity, precision, and accuracy.

To ensure that test results are robust and accurate, we will systematically adjust and test all components and variables to optimize the assay. It is likely that there may not be a suitable critical reagents (i.e. antibodies) available and therefore need to be generated.

To ensure highest quality, conformity and transparency, we apply our proven New Product Development Process to all assay developments. Naturally, EN 13612:2002 and EN ISO 23640:2015 requirements and applicable CLSI guidelines are incorporated in this process, as is writing part of the Technical File.

Verification and Validation (V&V) are critical steps in the assay design to prove that your product meets its requirements and specifications and that it fulfills its intended purpose. Both V&V are critical phases of your Design History File. This Design History File is part of the technical file of your product and above all essential to be FDA registered or CE marked. We can avoid delay in your product launches, because of our ample knowledge on and expertise.

Verification and Validation Available

Verification: Aim is to verify the assay designs, confirm by examination and provision of objective evidence that specified requirements have been fulfilled. Produced verification lots using R&D documentation are benchmarked against the design requirements. In addition, we will initiate accelerated stability studies for indicative shelf life data.

Validation: We will perform a technical validation and (accelerated) stability studies of the assay. At the manufacturing location, lots will be produced and QC released. They will be used for technical and clinical validation. At Future Diagnostics, we will perform a technical validation according to CLSI guidelines, which will be documented in appropriate reports complying with ISO 13485.

Future Diagnostics owns a fully automated non-contact dispensing system for spotting of your oligos, antibodies or proteins in ultra-low volumes.

Are you looking for someone to make the best spots for you on the surface of your choice? Look no further.

A micro-array is a collection of microscopic spots on a solid surface, such as glass slides, membranes or microplates. Micro-array spotting is mostly used in multiplex assays that detect multiple target analytes – like allergens, infectious diseases or auto-immune diseases – in complex sample types. It allows perfect profiling of several biomarkers in blood or urine samples.

We are your trusted independent partner for the development of many different types of IVD Products, with different technologies, either manually or automated. With 20+ years of expert experience and 150 IVD developments, our 70+ enthusiastic and highly skilled professionals are committed to accelerating healthcare innovation, providing high-quality assay development and manufacturing services.

Future Diagnostics offers in vitro diagnostic (IVD) immunoassay development services for Immunoassay Analyzers, ELISA, Microfluidic Point-of-Care Tests and Multiplex Micro-Arrays.

Whether you need highly specialized knowledge or manpower to bring your concept to market, we are your trusted independent partner for the development of many different types of immunoassays, with different technologies, either manually or automated.

We are ISO 13485 certified and boast our own FDA registered manufacturing facility, offering small to medium scale pilot and commercial production capabilities. Immunoassays, point-of- care (POC) tests or validation services – you can expect superior performance.

Apart from developing complete IVD immunoassays, we also offer verification & validation, analytical performance services, micro-array spotting, or antibody/antigen conjugations.

We make accuspheres to stabilize your biomolecules and enable ease of handling of your assay. The spheres can be used to reduce the assay turnaround time of any immunoassay. Standard spheres have a size of 50μl (approximately 4.7 mm diameter) and fit exactly in a single well of a microtiter plate.

Besides accusphere lyophilization, we also offer regular lyophilisation services. 

We will demonstrate the feasibility of the assays and optimise assays to meet the design requirements described in the product development plan. Our R&D team will produce a bench lot to confirm critical assay parameters before design freeze.