Companion Diagnostics

 

Lab21 has full capability to take companion diagnostic assays or biomarker assays from concept through to clinical trials and to validated, regulatory approved diagnostic assays for commercial distribution.
    Companion diagnostics are increasingly important, and often essential in the delivery of highly efficient and safe drug therapies. Companion diagnostics are used to: 
    • Stratify patients based on predicted efficacy or toxicity  
    • Monitor drug efficacy
    • Monitor drug levels
    • Monitor response to therapy
    • Monitor toxicity
    The phrase ‘Companion Diagnostic’ is typically applied to a laboratory assay that is required by FDA and/or EMEA for patient stratification to a specific, targeted drug or drugs. Other assays used in a similar way to ensure drug efficacy and safety include pharmacogenetics, drug resistance and therapeutic drug monitoring testing.

    Lab21 services in Companion DiagnosticsLab21 has full quality accreditations for the development, manufacture, and provision of diagnostic products and services for the global market.

    Lab21 is a vertically integrated diagnostics company

    Lab21 provides a vertically integrated service that can support Clients throughout clinical trials and beyond by providing biomarker analysis, development of the biomarker into a regulatory approved assay, global distribution network and service direct to healthcare providers to support the marketing of the drug post launch.

    Lab21 Clinical Laboratory     supports clients in Pharma, Biotech and CRO’s in the provision of specialist clinical diagnostics from the pre-clinical phase to Phase IV and beyond. Utilising custom built, fully equipped diagnostic and pharmacology laboratories with Cat II and Cat III facilities, we offer immediate access to our scientific knowledge, assay development, clinical trial and project management expertise.

    Lab21 Diagnostic Products manufactures regulatory approved immuno- and molecular diagnostic assays which are distributed globally through an extensive, global network of OEM and Distribution partners in addition to a direct sales force in Europe and the United States.


    Lab21 and Vertically Integrated Diagnostics