Clinical Trial Assay Development
Almac has extensive expertise in the development of biomarker assays for commercial partners across a wide range of technologies. We have extensive experience in the validation of assays across key regulatory standards, including; CLIA, CLEP, CE-IVD and FDA.
Whether we carry out the biomarker discovery ourselves, or pharma or biotech partners come to us with biomarkers of their own, we can develop them into clinical assays.
The process of developing a discovered biomarker into a test for clinical delivery is complex, but it is an area in which we have significant experience.
Our key area of expertise is in the development and delivery of multiplex RNA and DNA based tests, however our assay development and delivery services are not solely limited to multiplex assays. We also offer a wide range of platforms & technologies for delivery of DNA, RNA and protein assays.
- Determining the optimal platform for delivery of the assay
- Platform migration
- Tissue migration studies
- Assay transfer & appropriate analytical or method validation for clinical delivery
- Proprietary panel of qPCR reference genes
- Developing the assay instructions for use (IFU) and generating appropriate reference samples for use in validation studies or clinical delivery
- Verified and tested software to automate the production of test reports from raw test data (including algorithm analysis and QC)
- Test interface and report
- Analytical validation of the assay to CLIA, CLEP, CE-IVD and FDA standards