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Companion Diagnostics

Companion Diagnostics

What is A Companion Diagnostic?

A companion diagnostic (CDx) is a medical device, often an in vitro device, which provides essential information for the safe and effective use of a corresponding drug or biological product. The test helps a healthcare professional determine whether a particular therapeutic product’s benefits to patients will outweigh any potential serious side effects or risks. In 2014, FDA issued “Guidance for Industry: In Vitro Companion Diagnostic Devices,” to help companies identify the need for CDx at an earlier stage in the drug development process and to plan for co-development of the drug and CDx test. The ultimate goal of the guidance is to stimulate early collaborations that will result in faster access to promising new treatments for patients with serious and life-threatening diseases.


CDx Development Services Provided by Novogene

With scientific excellence, great customer service, and unsurpassed data quality, Novogene is committed to providing our pharma clients with front to end CDx services, including biomarker screening, CDx development & validation & registration, cGMP kit manufacturing, and marketing.

Case Study

  • Develop a CDx of a first-in-class anticancer drug A for an innovative pharmaceutical company.
  • Using the NovoPM™ solid tumor genomic profiling test to perform the potential predictive biomarker analysis on patient samples collected in phase I clinical trials of drug A.
  • Select the most suitable molecular detection platform to develop and verify the RUO (Research Use Only) CDx based on the biomarker analysis results.
  • The RUO CDx was used for screening prospective patients in phase II clinical trial of drug A and analyzing the predictive biomarker.
  • Once the predictive performance of the RUO CDx was validated, Novogene will manufacture and register the kit, then the RUO CDx will turn into Investigational Use Only (IUO) CDx. We will verify the performance of IUO CDx in phase III clinical trial of drug A.
  • We have found the potential predictive biomarker for drug A successfully.
  • We are developing the Research Use Only (RUO) CDx of drug A, which will be used in phase II clinical trials.