Custom Assay Development
Serametrix provides custom assay development and validation for patient enrollment and stratification when a CLIA standard is required. A project typically kicks off at the point when target analytes are identified. Serametrix can develop a de novo assay and scale up or commercialize assays for large scale clinical trials. Projects proceed through the following process:
- Initiate consultation meeting to identify exact needs of the project.
- Conduct a series of experiments to test reagents and define assay parameters.
- Discuss data to define deliverables and ensure the biomarker assay is fit for purpose.
- Test normal and cancer samples for assay validation, sensitivity accuracy, sample stability, and criteria for quality control.
- Upon validation, transfer assay to operations team for integration into ongoing or future clinical trials. Assays can be updated to CLIA as required.
A series of experiments based on initial consultation to ensure the required markers can be visualized using the chosen parameters for color selection, tube type and reagent concentrations
Meet with customer to share data from Stage 1 and collaboratively discuss the desired phenotypes in order to define deliverables
Using normal healthy samples and defined assay parameters to determine physiological range, limit of quantitation, reproducibility and sample stability over time in Cyto-Chex and other tube types that may be required to ensure assay is suitable: regional teams visit development lab to become familiar with assay at this stage. Define quality criteria for pass/fail.
Subject to requirements and time lines, test further samples of defined disease types to establish range of values within relevant disease areas (if required, can be applied in earlier stages in cases where markers were absent in normal samples)
Development Manager visits regional staff to provide onsite training and transfer validated SOPs. This is followed by same sample testing to ensure site to site variability falls within accepted quality criteria.
At each stage, the relevant translational and clinical teams are consulted for a truly collaborative result that delivers a tailored biomarker strategy that precisely meets the needs of the clinical trial.
To discuss ideas for your study or request a quote, click here.