CDx Development and Commercialisation


CDx Development and CommercializationCompanion Diagnostics

Most drugs work well in some sections of the population but less well, or not at all, in others. At a simplistic level, a companion diagnostic (CDx) is the test that identifies a sub-population likely to benefit from a particular drug.

To date all of the commercially available CDx tests are simple DNA or protein based assays (e.g. HER2 or KRAS). Success has been limited as there will only be a limited number of simple biologies that may be measured to predict benefit. In order to enable the next generation of CDx tests, assays that measure more complex biology will be required.


The Future is Evidence-Based Multiplex CDx

Multiplex companion diagnostics provide a proven means of capturing complex biology and will change the way medicines are developed, regulated and prescribed. We are uniquely placed to partner with clients throughout the entire process of MCDx development – from the fundamental research and discovery phase, through the conduct of clinical trials and the manufacturing of test kits, to the patient sample testing.Our scientists are experts in a wide range of scientific disciplines and have experience in working with FFPE tissue as well as fresh tissue. They are supported by teams of experts in disciplines such as bioinformatics, biostatistics, molecular biology, pathology, product development and quality/regulatory control. As a major global company, we have the financial stability to stand alongside our customers. We also have the organisational and logistical resources necessary to provide an end-to-end service, which can be scaled out to every major market from our clinical laboratory hubs in the USA, Europe and APAC.


Our Ground-Breaking Discoveries are Already Proven

We can demonstrate how MCDx can be used to:

    • Target drug development at known receptive populations
    • Expedite drug development, even at Phase I of a clinical trial
    • Evaluate drug performance ahead of Phase III
    • Extend the lifespan of a drug nearing patent expiry
    • Re-invigorate the potential for a new drug that has failed at clinical trial
    • Identify/establish a new niche for an existing drug
    • Produce clinical outcomes that convince clinicians and satisfy regulators

The data is out there. In FFPE samples and fresh tissue samples, the complex biomarkers and multiplex signatures that do exist are just waiting to be discovered.

View Almac’s webinar ‘Discovery, Development and Commercialisation of Multiplex Diagnostics and Companion Diagnostics’

Almac: Discovery, Development and Commercialisation of Multiplex Diagnostics and Companion Diagnostics from Almac Group on Vimeo.


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Quality Assurance

Quality Assurance

Almac Diagnostics is accredited by:

• UKAS to ISO17025 (accreditation number 2740)
• CLIA
• College of American Pathologists (CAP)
• New York State (CLEP Permit)
• Almac also holds individual US State licenses for Florida, California and Pennsylvania

Almac Diagnostics holds ISO13485 certification (SGS) and also complies with GLP, GCP and GCLP.




More Details

Quality Assurance

Quality Assurance

Almac Diagnostics is accredited by:

• UKAS to ISO17025 (accreditation number 2740)
• CLIA
• College of American Pathologists (CAP)
• New York State (CLEP Permit)
• Almac also holds individual US State licenses for Florida, California and Pennsylvania

Almac Diagnostics holds ISO13485 certification (SGS) and also complies with GLP, GCP and GCLP.