IVD Immunoassay Development

Future Diagnostics is your obvious choice for high-quality in vitro diagnostic (IVD) immunoassay development. Apart from developing complete IVD immunoassays on demand, we also offer flexible support in pre-feasibility, IVDR analytical performance studies, antibody/antigen conjugation and biotin interference free developments. Our enthusiastic and skilled experts will help your R&D team accelerate and bring your immunoassay to market successfully.

IVD Immunoassay Development Services for clinical analysers
IVD Immunoassay Development Services for ELISA

How we develop immunoassays

When developing an immunoassay, what we do, in essence, is choose a format, gather the right components, and construct a good working protocol. Every immunoassay format provides a different level of specificity, sensitivity, simplicity and speed, and requires different numbers and varieties of components.

To ensure assay test results are robust and accurate, we will systematically adjust and test all components and variables in order to optimise the assay. When we develop an assay from scratch, our objective is usually a ‘new’ biomarker. This means that a suitable pair of antibodies may not be available, and we will need to generate the right antibodies.

How we work

Different disease areas

We have successfully developed a wide variety of immunoassays that help clinicians diagnose and monitor diseases, and manage and improve patient outcomes.

Our portfolio includes assays for diagnostics in the following disease areas:

Cardiovascular disease Troponin I, BNP
Infectious disease HBc, HIV
Autoimmune disease CCP, GAD
Bone metabolism disease (Free) Vitamin D, PTH
Oncology p53, PSA
Endocrinology 11-Desoxycortisol, DHEA
Anaemia EPO, Folate
Diabetes C-Peptide, HbA1c
Development was accomplished professionally, efficaciously and proactively. Excellent communication was highly appreciated. - IVD Biotech Company

Rapid delivery to market

Bringing in years of specialist experience and a proven development approach, our dedicated team of professionals will help you market your assay fast and cost-effectively. Naturally, your assay will be developed in compliance to ISO 13485, and you will receive the complete Design History file from us. This means your assay is ready for IVD and/or FDA approval in your name.

Would you like to find out more about our IVD immunoassay development services?

We’d love to hear from you!

Contact us