Companion Diagnostics (CDx) – role of biomarkers and effective collaboration

The era of “one-size fits all” is slowly disappearing and tailored medicine is in great demand in todays world. The need for safer and effective drug therapy has lead pharmaceutical companies to a major paradigm shift in their business model.  In today’s drug development programmes, the identification and qualification of biomarkers are integrated.  Pharma companies are collaborating with diagnostic makers in developing biomarker-based tests that enables classifying patients into subpopulation for appropriate decision making on the use of a therapy, also termed as Companion Diagnostics (CDx).

Biomarkers plays a key role in CDx development, especially predictive biomarkers that can help select a patient population with a higher chance for a favorable response to a specific kind of medicine.  However, it can be difficult to find clinically useful predictive biomarkers early on in a drug development, because they can only be validated based on patients response to the drugs.  A lack of good model system to assess the weight of evidence of biomarkers that predict clinical response is a key issue.  Using animal models to validate biomarkers isn’t always successful when translating into humans.  Alternative technologies/methods is in great demand to validate biomarkers.  Several ex-vivo methods for diseases like Crohn’s disease and rheumatoid arthritis have been discovered but are still in the early stage of investigation.

The front-runner in personalized medicine has been Oncology.  Access to tissue biopsies and their long-term storage capabilities has paved the way for several tissue based companion diagnostics in this area.  Table 1 below depicts some of the oncology based companion diagnostic products approved or cleared by the FDA.

Table 1: List of companion diagnostics approved or cleared by FDA

Table 1: List of companion diagnostics approved or cleared by FDA

Several other diseases need alternative technologies or methodologies to validate related biomarkers for companion diagnostics.  More emphasis needs to be made in the areas of neuroscience, cardiology and infectious diseases for customized treatment. However, a biomarker needs sufficient evidence to qualify it as clinically useful for predictive use and lack of good model system is the biggest hurdle.

Currently, several organizations, institutes and companies are coming together to form pre-competitive collaboration in order to accelerate the identification and validation of clinically useful markers. For further information on the trend toward biomarker consortium development, you can read my blog article on the subject here.

How can better biomarker discovery and validation efforts aid the development of quality drugs and companion diagnostics? What are your thoughts on the role biomarkers should, and can, play?  

Please share comments below.


  4.   The New York Academy of Sciences, “Companion Diagnostics: From Biomarker Identification to Market Entry”, April 28 – 29, 2014

Supriya Shekar

Co-founder at Medbiomarkers
Supriya Shekar is a Co-Founder of Medbiomarkers, a company accelerating the translation of biomarker research via providing data and software solutions and building biomarker related consortia. Supriya has over 8 years of experience in developing molecular diagnostics including IVD assays and companion diagnostics in the areas of infectious diseases and oncology. Most recently she worked in the Companion Diagnostics division of Novartis.