Pharma Services - Biomarker Progression™
CancerGuide offers unique and innovative methods for the development of clinical-grade companion diagnostic tests and molecular characterization profiling services, to augment biomarker and co-development clinical trial strategies of pharmaceutical and biotechnology companies.
CancerGuide offers the first fully integrated biomarker development, progression, and commercialization capability. The suite of companion diagnostic services includes clinical-grade test development (on FFPE), clinical trial protocol and design support, and advanced bioinformatics/testing/profiling to enhance your biomarker strategy at any stage of preclinical and clinical development.
At CancerGuide your biomarkers can evolve and progress through clinical development using a whole genome measurement approach so that in the event that the original structure does not perform well as a biomarker, there is still an opportunity for future discovery from the dataset.
CancerGuide has the capabilities, expertise, and resources to enhance the results of your biomarker strategy at any stage of clinical development.
Feature Service: Phase II Biomarker Co-Development
CancerGuide has the collective resources to build a Biomarker Co-Development Roadmap to “operationalize” your biomarkers entering Phase II. Throughout the Phase II planning process CancerGuide will provide expert delineation of trial design elements, including SOPs for sample collection and processing (that enable full genome assays), dynamic QS and design control programs, testing, timelines, and resources necessary to achieve a Phase II endpoint of a clinical-grade diagnostic that optimizes the value of your therapeutic.
CancerGuide will utilize its biomarker genomic knowledge database to guide decisions regarding initial patient populations for testing efficacy. Our expertise in biomarker development will aid refinement of initial tests and their translation to diagnostic commercialization. Testing expertise via our partnership with LabCorp will guide the implementation of your co-development strategy. Throughout the process, CancerGuide will bring to bear substantial expertise in critical diagnostic design elements (including specimen format, exact gene list, IVD platform, clinical utility, and regulatory requirements).
CancerGuide’s value to the process of biomarker progression, from initial Phase I through Phase II and into Phase III is the ability to; 1) validate a signature’s Phase II readiness and robustness, and 2) provide genome-scale expression assays that enable better “intra-Phase” discovery and options, and ultimately reduce pipeline attrition.
Once your companion diagnostic is developed by CancerGuide you will need to begin the process of establishing "clinical utility". Aided by the comprehensive development and commercialization agreement with LabCorp, CancerGuide provides an innovative development-to-commercial market platform for emerging molecular oncology diagnostic technologies. Together, we can establish the clinical utility of your assay and assist your company in having a clinical-grade assay on the market synchronized with your therapeutic.
If you are a drug developer, interested in our valuable services, please contact us at pharmaservices@cancerguidedx.com, with a brief description of the nature of your project and inquiry. We look forward to hearing from you.