Companion Diagnostics – Partnering for Personalized Medicine

Industry Insights from Paul Meade, M. Sc, MPH

When the Human Genome Project was finally completed with the mapping of the genetic sequences of our DNA, there were many predictions about how the face of medicine would change forever. We would finally figure out how to cure diseases linked to genetic aberrations, find ways to enhance our interaction with the environment, and develop medicines that are tailored to fit our unique genome. But a decade later, we are all aware of just how painfully slow progress has been to date. However, one area that is advancing steadily is the use of companion diagnostics.

Everyone was quick to point to Herceptin and the prototype example of a diagnostic test that was required to be use prior to prescribing this chemotherapeutic agent for women with breast cancer that over-expressed the HER2/neu gene. But now there are more examples of such companion diagnostics, and the list continues to grow.

What does all this mean for the future of medicine, and the interaction among the diagnostic and biopharmaceutical companies? When we can go to a physician’s office, be correctly diagnosed, and then given a medicine to take knowing in advance that we will have a high probability of responding, without suffering from annoying side effects, then we will have personalized medicine.

Does that mean that people will have their own “designer” drugs specific to their unique genome? No, of course not. But it does mean that based on your similarity to a known genetic type, or genotype, your response to the medicine will be highly predictable, and therefore “personalized” to your specific needs. Thus, many drugs introduced in the future will have a unique companion diagnostic that will inform a specific response, and the cost benefit of taking such a drug will increase tremendously. As the old saying goes, “the most expensive drug in the world is the one that doesn’t work!”

Does that mean that companion diagnostics will be forever married to new therapeutic agents? Not really. As our knowledge of population genetics expands, and our characterizing of many different genotypes increases, we will likely get to the point whereby known genotypes will be mapped to known therapeutic agents, and the need for each new product to have its own companion diagnostic will diminish with time. But until then, expect to be given both a test and a prescription when you are treated at your nearby physician’s office. The road from general to personalized medicine is a long one that will take a great deal of research. But once we get there, the administration of medicines will gain a huge leap forward in effectiveness and efficiency.

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