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Concept and Feasibillity

Despite their potential for use in a clinical setting, the vast majority of biomarkers never make it to the clinic, primarily due to shortfalls in the biomarker discovery process. Consequently, the early stages of developing a companion diagnostic are critical in determining the success of the final product.

The initial Concept and Feasibility studies are required to develop the assay such that it is suitable for entry into the Design Control pipeline. This may require assay development or tech transfer of an existing assay from the client.

These studies may also focus on proving the biological utility and effectiveness of the biomarker as well as identifying a technology platform and chemistry suitable for development into a diagnostic product. At this stage it is also vital to assess the suitability of any proposed clinical trial designs for use in companion diagnostic development; this is also applicable to the assessment of clinical trials that are intended for the retrospective validation of a CDx.

Biomarker discovery and verification

Our biomarker services portfolio offers you access to a broad range of technology platforms, including our own proprietary Invader and Nucleon chemistries, in support of your CDx development program. Our services range from DNA and RNA extraction through to downstream genomic services and bioinformatics:

Tepnel Pharma Services has experience in biomarker discovery and development in a broad range of disease areas including:

Data analysis and bioinformatics

In partnership with Fios Genomics Ltd. we offer a wide range of bespoke data analysis solutions and bioinformatics for a variety of application areas (e.g. biomarker discovery, gene expression and methylation analysis). Services range from data QC and basic statistics to advanced approaches such as network and pathway based analysis, clustering techniques, data integration and data mining to produce a comprehensive picture of the underlying biology of your experiment.

Assay development

Have you already identified a biomarker? We can evaluate your in-house assay to determine its suitability for use as a potential companion diagnostic test. This method transfer and evaluation process will allow you to proceed through the product development process with the confidence that your assay is future proofed for clinical use.

Don’t have an assay? Tepnel has a wealth of experience in the design, development and validation of custom assays using a wide range of technology platforms, including our proprietary Invader chemistry. All assays are developed to meet your future needs, whether they are RUO, GCP or for use as a potential companion diagnostic test.

Platform migration

While high density platforms such as microarrays represent a powerful tool for biomarker discovery, their high cost, long turnaround time and complex data analysis requirements render them relatively ineffective in a clinical setting.

Tepnel has experience in using bioinformatics tools to migrate a candidate biomarker to a clinically relevant platform, e.g. from microarrays to qPCR, Invader, TMA. This process involves an initial assessment of your existing data, followed by a combination of laboratory work and data analysis to migrate your biomarker to the most clinically relevant platform and chemistry. Following migration, a validation of the new biomarker is carried out to determine if the assay is suitable for progression into the product development process. This validation process can also be applied when, for example, the initial biomarker discovery was carried out using fresh frozen tissue and a migration is required to allow the test to be used with formalin fixed, paraffin embedded tissue.

Sections in Companion Diagnostic Services

All Companion Diagnostic Services

Additional Resources

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