Faq category: IVD assay development

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.

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…

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. Please see our portfolio here

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.

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 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…