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Related Experiment Video

Updated: Feb 10, 2026

Using Micro-Electro-Mechanical Systems MEMS to Develop Diagnostic Tools
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Challenges in the codevelopment of companion diagnostics.

Mathew W Moore1, Deepti Babu2, Philip D Cotter3

  • 1ResearchDx, 13766 Alton Parkway, Suite 147, Irvine, CA 92618, USA.

Personalized Medicine
|May 18, 2018
PubMed
Summary

Companion diagnostics are vital for personalized medicine but face significant hurdles. This article details the complex challenges in developing drugs and companion diagnostics together.

Keywords:
codevelopmentcompanion diagnosticsdrug–diagnosticpersonalized medicinetherapeutic

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Area of Science:

  • Biotechnology
  • Pharmacology
  • Medical Diagnostics

Background:

  • Personalized medicine offers revolutionary healthcare potential.
  • Companion diagnostics are essential for the safe and effective development of personalized therapeutics.
  • Regulatory guidance increasingly emphasizes drug-diagnostic co-development.

Purpose of the Study:

  • To identify and discuss the challenges in co-developing drugs with companion diagnostics.
  • To highlight the complexities that hinder the full realization of companion diagnostics' promise.

Main Methods:

  • Review of logistic, strategic business, regulatory, and financial challenges.
  • Analysis of the drug-diagnostic co-development process.

Main Results:

  • The path to co-developing drugs and companion diagnostics is complex and fragmented.
  • Multiple unresolved difficulties impede successful co-development.

Conclusions:

  • Addressing the identified challenges is crucial for advancing personalized medicine.
  • Overcoming these hurdles will enable the effective integration of companion diagnostics with therapeutics.