The Evolving Companion Diagnostics Landscape

October 1, 2017

Jason Christiansen, Vice President Diagnostics, Ignyta

For you, why is a biomarker and diagnostic strategy so important and where is the most value gained from this approach?

Our goal is to help patients with cancer. To achieve this you have to find the most responsive patients, and that of course is where the diagnostic comes in, and obviously you want a therapeutic to match with this. With many clinical trials available, it’s even more important to identify these patients in order to understand the drug’s efficacy and safety, and increase the chances of a drug being successful. This makes a diagnostic absolutely critical.

How is Ignyta championing precision medicine drug development?

We are an integrated Rx-Dx company. So for us, precision medicine is all we do. All of our efforts are focussed on building companion diagnostics for our drug pipeline in house so we can manage the entire development cycle of drug and diagnostic pairing.

What is the biggest challenge currently facing the precision medicine community?

There are so many. Having a precision medicine approach means you’ve got a smaller population of positive patients and so the companion diagnostic may not always be the right model. The biggest challenge to me is the regulatory landscape around companion diagnostics. Trials are global, there are many regulatory authorities and testing is becoming more sophisticated at a local level. How do you connect all the knowledge gained developing a companion diagnostic to get patients the broadest number of options for testing worldwide?

Where does the greatest opportunity lie/ what is the next breakthrough needed to accelerate the robust stratification of patients and the subsequent development of targeted therapeutics?

You never know what you are missing until you find the missing thing! With the rise of immuno-oncology and we still need a better understanding of the biology and better tools for the immune system. I think this would impact other targeted therapeutics as well as immunotherapies because at the end of the day, you’re trying to  build a highly sensitive set of tools for the disease, but the biology is not fully understood yet. If you could get those two things to work together, then you will certainly find all the differences in a heterogeneous patient population. This leads to better assessment of efficacy of your drugs or possibility to develop new drugs to fit a profile.

What does the industry need to achieve in order to deliver the true value of diagnostic enabled therapeutics to patients?

For me, it just comes back to an understanding of companion diagnostics and the appropriate level of validation to provide robust testing. This needs to become more transparent and more transferable, because no patient benefits from a bad test. So it is in everyone’s interest to get the best testing broadly available.

Which technologies are you most excited about regarding the future discovery of novel biomarkers?

NGS, to me, is just a tool with high sensitivity, so it’s how people are using that tool that excites me. It’s not just sequencing DNA, it’s all of the other things that people might begin to look at, the new biological understanding and the data mining that goes along with it.

I also think you will start to see proteomics come back again. The ultimate target of a drug is the protein, and we moved away from proteomics because NGS was so sensitive.

But we’re starting to get better at proteomics again. The technology is evolved now to allow people to get more sensitive read out and the focus on circulating markers, which may be easier to measure, are making this approach more attractive.

What are you most looking forward to at World CDx & 2017?

The most interesting thing about this meeting is you have regulatory people there, you’ve got diagnostic manufacturers and testing people and you’ve got pharma. So for all of these questions that you’ve asked me above, these groups will have to figure out and will have to work together to make this right. The nice thing is, you’re starting to see more and more collaboration. You’re starting to see that both Rx and Dx people realize they actually need each other. The therapeutic companies need to work with the Dx companies to find patients for their drug and the Dx companies need to understand the risks and cost that the therapeutic companies undertake to make these drugs work.

It seems like exciting times ahead for Ignyta, what should we be looking out for on the horizon in the near future?

Although there are many drugs and companion diagnostics in clinical trials now, the real impact has not been felt for all patients seeking treatment with new drugs and testing methods. When the approvals for these new approaches begin to come through we will really marry Rx and Dx for precision medicine in a way that will provide broad benefits to cancer patients.