Companion Diagnostics

companion diagnostics

Your data course:

  • Are you seeking an alternative to early-lock in with a large, platform-dependent companion diagnostics player?
  • Do you require de-risking your companion diagnostics approach to expanding your flexibility and options in both intellectual property and time?
  • Are you seeking time and cost savings in your tissue-based companion diagnostics planning?
  • Do you require a CLIA laboratory that can run your novel assay as a lab-developed test while also working with you on a companion diagnostic filing?

Our map to the answers:

Flagship’s pathologists, cancer biologists and image analysis scientists have been engaged in various aspects of formal companion diagnostics development. Flagship is platform independent in both immunohistochemistry and image analysis, so our clients can keep their options open, customizing each CDx program to the best-of-breed antibody and platform. Flagship partners closely with multiple expert tissue antibody manufacturers, saving our clients substantial time and money.

Flagship assists our clients in planning their CDx programs, from evaluation and selection of antibodies, to screening, to cut-point analysis and scoring approaches. By participating in FDA IDE processes on behalf of our clients, Flagship works at each stage to save time and money, and keep options open as long as possible.

Flagship also assists our clients by developing CLIA-compliant, lab-developed tests. These are typically in areas where no reference lab approach exists and requires a sophisticated combination of pathology talent and custom image analysis. Flagship can deliver both a lab-developed test in our own laboratory as well as in other Flagship partner laboratories in the United States, Asia or Europe.

See the following pages to read more about our Companion Diagnostics services: