Customized Immunoassays on IVD Platforms

Thermo Fisher Scientific offer assay development expertise and tests tailored for your needs. We develop your custom immunoassay on one of our automated IVD platforms together with standardized reagents to yield excellent reproducibility and accuracy. We collaborate with clinical and assay development departments in pharma – from biomarker development to solutions for doctors’ offices with our point-of-care testing.

Efficient processes and specialized staff ensure fast development and high performance on a wide range of platforms. Our products, services and expertise are based on more than 40 years of R&D in immunology and assay development. With extensive manufacturing capabilities, regulatory experience, certified analysis laboratories and a global supply chain, we can support you all the way from R&D assay development to post-market diagnostics.

Immunogenicity Testing

Monitoring Anti-Drug Antibodies (ADAs) is critical for ensuring safe and efficient administration of biotherapeutics. The key analytical challenge is to measure very low concentrations of ADAs in the presence of soluble drug, as well as ADAs of different isotypes. The ImmunoCAP® assay enables customized developed RUO assays on an automated IVD platform together with standardized reagents to yield performance, stability and reproducibility for reliable analysis.

We can help you detect ADA in screening and confirmatory assays followed by a determination of the isotype of antibodies (IgG, IgE, IgG4, IgM and IgA) on the same solid phase. The use of our standard reagents, evolved from the development of clinical routine assays and subjected to regulatory approval, shortens the development time of an assay intended for use in clinical trials.

To discuss a customized immunoassay, please contact us at diagnostics.partnering@thermofisher.com

 

As in all diagnostic testing, the diagnosis is made by the physican based on both test results and the patient history.