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Current Status of Companion and Complementary Diagnostics: Strategic Considerations for Development and Launch.

H Scheerens1, A Malong1, K Bassett1

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Summary

FDA-approved diagnostic assays are crucial for patient care, enhancing lifespan and quality of life. This tutorial explores strategies for developing companion or complementary diagnostic assays for regulatory approval.

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Area of Science:

  • Biomedical diagnostics
  • Regulatory science
  • Translational medicine

Background:

  • FDA-approved diagnostic assays are vital in modern patient management.
  • These assays support safe and effective therapeutic use (companion diagnostics) or optimize benefit/risk profiles (complementary diagnostics).

Purpose of the Study:

  • To review strategic considerations for developing diagnostic assays.
  • To guide the process for achieving FDA approval as companion or complementary diagnostics.

Main Methods:

  • Review of regulatory pathways for diagnostic assays.
  • Analysis of strategic decision-making in drug and assay co-development.
  • Examination of factors influencing companion and complementary diagnostic approval.

Main Results:

  • Diagnostic assays are increasingly integral to patient care and therapeutic strategies.
  • Clear distinctions exist between companion and complementary diagnostic roles.
  • Strategic planning is essential for successful regulatory submission and approval.

Conclusions:

  • Developing FDA-approved diagnostic assays requires careful strategic planning.
  • Understanding the roles of companion and complementary diagnostics is key.
  • This review provides a framework for optimizing drug and assay development for regulatory success.