Custom Signature Development
For our clients in the pharmaceutical and biotechnology industries, CancerGuide develops or augments the development of gene expression-based signatures utilizing our proven methods and cancer genomic expertise.
CancerGuide signature development services offer unique value to our clients:
CancerGuide’s proprietary methods enable the creation of an accurate diagnostic assay, very early in the development cycle – even before the first patient is treated.
Proven translation and normalization capabilities from cell line generated signatures to tumor sets with actionable result data
CancerGuide’s genomic signatures of response (GSRs) are based on the analysis of tens of thousands of gene expression products and not just the handful thought to be involved in the targeted mechanism, resulting in a more robust report of the phenotype of interest.
CancerGuide's methods have a proven track record of producing targeted diagnostic assays that are predictive of clinical outcomes.
CancerGuide can often develop a custom candidate GSR in as little as 90 days.
These capabilities allow our clients to fully leverage the selectivity knowledge throughout the development cycle and to establish highly profitable and defensible niche markets.
CancerGuide's development programs will be based on a combination of the results from a series of bench-top cell proliferation assays using the candidate drugs of interest and computational analysis of these results.
The two general categories of CancerGuide signature development services include Drug Sensitivity signatures and Pathway Activation signatures:
CancerGuide Drug Sensitivity Signatures
This approach makes use of a diverse panel of cancer cell lines to carry out drug sensitivity measurements of a candidate drug. Gene expression data from the cell lines demonstrating extreme sensitivity and resistance to the drug are used as a training set to generate a signature that can predict sensitivity to a given cancer therapeutic.
CancerGuide Pathway Activation Signatures
The second approach makes use of experimental conditions to selectively activate cell signaling pathways of interest. Often, this makes use of recombinant adenoviruses to express an activating protein in an appropriate cell culture system. This has been proven to be an effective mechanism to develop signatures of cell signaling pathway activation.
The value of this approach lies in the demonstration from various studies that measures of pathway activation with these signatures can also predict sensitivity to cancer therapeutics that target components of the relevant pathway.
CancerGuide is more than an expert signature development partner. We have the "know-how" to assist in the design and execution of novel early-stage clinical trials utilizing a targeted pathway or a client’s custom signature(s).
CancerGuide, with its strategic partners, is building the expert capabilities to take a newly-developed signature from discovery, to analytical validation, to clinical validation, to a distributed IVD assay on the market, compliant with regulatory bodies.
CancerGuide can take a research signature in a Phase I or Phase II study and ensure you have a true "clinical grade" companion diagnostic assay, which will very likely form the evidentiary basis for going into a Phase III study.
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 have a commercially viable assay on the market synchronized with your therapeutic.
CancerGuide generally performs these services on a fee for service basis. CancerGuide also has a flexible and client-conducive approach to intellectual property related to signature development projects.
If you are a drug developer, interested in these valuable services, please register by emailing us at pharmaservices@cancerguidedx.com. Please include a brief description of the nature of your project and inquiry. We look forward to hearing from you.