Covance employs a number of approaches to help clients convert biological findings from genome-wide studies into targeted biomarker assays with clinical utility. We are experienced in helping clients develop potential biomarkers from complex datasets and converting those into validated assays that can be used in clinical development. CGL is a CLIA-certified laboratory and also offers assay validation, execution and reporting to meet GLP requirements.
The Covance Biomarker Strategy Plan
Covance Genomics Laboratory (CGL) can assist in the development of Biomarker Strategy Plans. This consulting service helps you develop and design experiments to identify putative biomarkers. Our team has experience with identifying genes from Phase 0 to Phase 3 in projects ranging from mutational analysis (KRAS, BRAF, EGFR), gene expression, miRNA profiling, and genotyping.
Biomarker Development Services
Along with leveraging internal expertise, the CGL Biomarker Translation team interfaces with groups across Covance to identify and develop putative biomarkers. Various approaches can be designed using clinical and pre-clinical models, including cell line screening, screening of samples from biobanks, xenograft models, molecular profiling of preclinical samples, as well as ex vivo dosing of whole blood.
Biomarker Validation Services
CGL offers assay validation and clinical qualification for RNA, DNA or miRNA biomarkers and panels. Our in-house laboratory has a high level of sensitivity and reproducibility for the detection of both prognostic and predictive genomic biomarkers.
Direct Clinical Support
Along with support in biomarker identification, we can leverage our partner groups within Covance to support your study's regulatory filing and preparation for the market.