CDx Development & Testing

CDx Development

  • 220 FDA Cleared Assays

  • 700 CE Marked Assays

  • In-House Regulatory Team

A key element to realising the potential for personalised medicine is in CDx Development and Testing. Personalised medicine is the result of our increased understanding of disease complexity and variability.

 

It is now accepted that the future of pharmaceutical industry is dependent on the development of therapeutic agents that are more closely tailored to targeted patient group or subgroups.  As a result safer drugs are developed with enhanced therapeutic efficacy with related healthcare savings.

 

 CDx utilises a diagnostic test to determine whether a patient will benefit from the drug in development. The test predicts a patient’s response by looking at specific biomarkers or genetic mutations unique to how the disease manifests itself.

 

Randox has been delivering clinical diagnostic and biomarker solutions to the global pharmaceutical industry for over 35 years. We  aim to meet the need for identifying the clinical utility of a marker and the value of the diagnostic test.

 

With over 220 FDA cleared and over 700 CE marked assays we are the ideal CDx partner. We offer the full package of diagnostic and CDx assay development, optimisation, and regulatory approval.

 

 

 

  • Antibody Development / Selection

  • Custom Development

  • Randox Clinical Laboratory Service

  • Project Management

  • Your Ideal CDx Partner

Why Choose Us?

Capabilities to bring a project from antibody development to global commercialisation

We are a primary manufacturer for all components of the CDx-Assay, controls, calibrators, instrumentation

Expertise across a broad range of therapeutic areas including orphan diseases

In-house antibodies and recombinant proteins are ready for immediate transfer to assay development

Our in-house biotechnology group enables custom development and scale up of monoclonal and polyclonal antibodies, antibody fragments (Fab’s, ScFv’s, sdAb’s) and recombinant proteins

Global distribution and operations in over 145 countries ensuring no block to commercial adoption of the CDx

Quality control, calibrators, and proficiency testing solutions are available to support the CDx assay

Global technical support and engineering ensuring quality customer service

Established agreements with leading global CRO’s for CDx pivotal trials

Full regulatory support at Randox for FDA, PMA, CE and all key international regulatory authorities