Assay development & validation

Synexa specialises in custom-designed assays that take into account the priorities of the sponsor, the biology of the drug and known mechanisms of the pathway being targeted. Most of our work involves developing de novo assays or optimising existing commercial assays for a particular matrix or context, allowing the sponsor great flexibility in conducting clinical trials.

Each assay is developed and validated in-house in close partnership with the sponsor, with an emphasis on robustness and sensitivity in new assay development.

Depending on client requirements, assay development and validation can be performed for exploratory research purposes, which is quicker and cheaper, or to meet full FDA/regulatory standards.

Thorough assay development, optimisation and validation is best done well in advance of fieldwork, as the process can deliver significant improvements in assay sensitivity, with big implications for sample volume and sample prep methods. Well thought-out assay optimisation can ensure the delivery of robust and insightful data and can often can save a clinical trial from considerable wasted effort. We strongly recommend starting the development and validation process at least six months before the first sample is drawn.