Assay Design & Development

Insight Genetics is enabling precision medicine in cancer care. Our Research and Development team specializes in designing and developing molecular diagnostic solutions to identify biomarkers and help pinpoint patients’ cancer types, thereby guiding more effective treatment. There are two core areas of precision medicine:  

    1)    Therapies that target disease-causing genetic abnormalities  
    
    2)    Diagnostic tests that identify the patients who will respond to a targeted therapy

With newly finalized guidance by the FDA, and the pressure imposed by payers responsible for reimbursing the high cost of targeted therapies, there has never been a more critical time to deploy a diagnostic-driven clinical trial testing strategy.

Insight Genetics helps our clients navigate assay design and development and clinical testing throughout the drug development process. Utilizing a stepwise approach focused on increasing validation according to regulatory standards ensures our clients obtain the right test for the intended use. For more information on our Development categories of Research Assays, Clinical Trial Assays and Companion Diagnostics, contact us.