Data-Centric Approach to Tissue Pathology for CDx Development

When looking to develop a Companion Diagnostic test (CDx) in the complicated world of precision medicine, you need a trusted partner with deep experience developing novel biomarker tests in a regulated setting.

Flagship’s unique data-centric approach to tissue pathology allows you to confidently develop the right CDx test to ensure you find the optimal patients for your therapeutic.  No matter the assay technology (IHC, CISH, FISH, Multiplex) and interpretation (manual pathology, image analysis) required, we guide you through the complexities of CDx development so you can focus on treating the disease.

View and download our info. sheet on how drug development success improves with co-development of an appropriate companion diagnostic biomarker. And, read our blog on Tissue-Based Diagnostics in a Regulated Space from a recent webcast.

WE ARE HERE TO HELP YOU WITH YOUR CDx AT EVERY STAGE OF THE DEVELOPMENT PROCESS:

Consultation on approach to yield best results

    • Discuss strategy and review options with our regulatory, assay development, and pathology experts
      • Allows for a comprehensive approach with enough flexibility to adjust to the real-world challenges of clinical trials
      • Flagship’s involvement can start as early as preclinical studies to provide continuation for future Phase I assay development

Preclinical assay development and research support

    • Compare assay results in cell lines/xenografts
    • Target prevalence screening in normal/diseased biobank tissues or tissue microarrays (TMAs)

Create a novel test using Flagship’s unique data-centric approach to tissue pathology and analysis

    • Advanced wet assay options along with Flagship’s proprietary image analysis technology and workflow allow you to determine what tissue endpoints will lead to selecting the right patients

Validate the test as a CLIA Lab Derived Test (LDT) to create a prototype CDx in which to select patients for your clinical trial

    • Image analysis data is collected, regardless of test interpretation, to ensure that the selected endpoints and cut points are optimal as patients enroll in the trial
    • Assist in the clinical protocol development by providing biomarker analysis plan and accompanying manuals
    • Develop a sound sample retention strategy to support later biomarker assay development toward potential CDx
Utilize Flagship’s CAP/CLIA lab to run the LDT for patient selection into your trial
    • Review pathology image analysis data for real-time treatment response monitoring
    • Adjustments to the LDT/cut point can be made, if needed, without re-running the trial as all data has been collected for every patient

Since Flagship is independent from any assay manufacturer, we help you choose the best manufacturer for your specific assay needs and work with them to ensure the performance meets all requirements

    • We support both the validated assay as well as the test interpretation performance data

We partner with you and your selected assay manufacturer for the regulatory submission

We can also develop and support a single-site FDA submission for running the CDx at Flagship’s CAP/CLIA lab if required, as well as serve as your interface with the regulatory authorities

While your preferred assay manufacturer completes their regulatory submission and production process, Flagship will run your CDx in our Clinical Diagnostics CAP/CLIA lab

    • We will remain a center for excellence for your CDx as the test gets wider distribution
    • Image analysis reporting is supported centrally regardless of where the CDx wet assay is performed

If the test proves too challenging for distribution, we will support your CDx as a single-site FDA test in our Clinical Diagnostics Lab.