Personalised medicine is a very popular topic in healthcare as a path towards better and cost-effective treatment of patients. However, we are not there yet due to various reasons. One of the major reasons is lack of diagnostic tests that will equip clinicians with the correct tools to make the right medical decisions. 

In this review we will discuss the benefits and challenges of developing diagnostic tests or so called companion diagnostic devices which provide information regarding safety and efficacy of the corresponding therapeutic product. 

What could be the benefits of companion diagnostics?

  • They help identify patients who will respond better to the therapy; have fewer side effects and improve their quality of life;
  • They allow clinicians to identify the best treatment options for their patients, save time and money from unnecessary procedures and treatments;
  • They will help regulatory agencies to better understand and evaluate the safety and efficacy of new therapies;
  • They will allow improving drug development timelines and reducing costs.

These are some of the benefits of having powerful diagnostics to help make decisions regarding patients’ treatment.

What kind of challenges are there for developing companion diagnostics?

  • In cases where there is limited information about the disease or the mechanism of drug action developing companion diagnostics could be a serious challenge;
  • Often drug development and diagnostics development follow their own pathways which means that by the time the drug reaches phase 3 the diagnostics may not be ready to be used to select the correct patient population;
  • The reliability of the test is also important – high prevalence of false positive or negative results will compromise its use;
  • Current healthcare systems often do not reimburse the full costs of such tests which discourage their usage;
  • The laws for intellectual property are different for companion diagnostics and often they allow creation and marketing of cheaper but not validated tests;
  • Companion diagnostics are regulated differently than medicinal products, which mean there could be significant delay before they reach the market.  

While there are definitely challenges in developing companion tests they are the future of precision medicine so we hope we can see changes that will provide greater support for developing and testing companion diagnostics.


Developing companion diagnostics for delivering personalised medicine: opportunities and challenges

Author: Olga Peycheva

Olga is a clinical research professional who has been working in clinical research since 2005. She has extensive experience in clinical research in Eastern and Western Europe. 

Originally published on 3 June 2019