a $4M grant by the American Recovery and Reinvestment Act as a National Cancer Institute initiative in Physical Sciences in Oncology.
X: How was Epic Sciences born out of this?
PK: As scientists on the research side, we were doing a fairly large number of observational studies, testing the technology and trying to understand the disease. Eventually, one has to do trials under a regulatory compliant framework so that can go forward through an FDA submission to become a real product for standard use in clinical care, only then will you have a breakthrough that makes a difference in individual cancer patients. That of course is something we cannot do in the research world. Instead you do that in a commercial setting where you develop the practices that adhere to what is regulatory compliant. Recognizing that, we started Epic Sciences as a spinout out of Scripps. David Nelson is the CEO and president of Epic, and Epic has exclusive license to the technology itself for full commercial use. Epic is set up to push this as a fluid biopsy for biomarkers, and develop predictive tools that stratify patients for particular drugs at any particular time.
X: How do you see this advance, along with other advances in diagnostics, fitting into the notion of quantified health and personal medicine?
PK: The next stage of personalized medicine and effective healthcare must have an approach that I call the ‘companion for life’. The fluid biopsy and the HD-CTC technology are just the initially validated product that can predict response to a particular drug but the next step is the integration of this test at one time point with many time points during the entire lifetime of the patient. Obviously each time the patient has a different question but the decision will get better and better with time. For that same reason, we want to add other data items into this equation. Just like a search engine gets better with more and more queries being run, the ‘companion for life’ will perform better and better the more data we feed into it. Our current advances in cancer diagnostics have to be connected with new products in wireless medicine and then drive the data assimilation to provide high-quality guidance on treatment strategies over long periods of time.
X: Does a tumor have to reach a particular stage before it begins shedding these circulating tumor cells? Does it shed these cells more or less continuously, like a leak, or is it more like a dandelion blossoming?
PK: That’s where the science is fascinating. To be perfectly honest, we don’t know very much about this process. We needed to develop these highly, highly sensitive analytic tools to be able to investigate this question and all related aspects of cancer development in a patient.
We know that from a growth perspective that there is a lot of blood vessel growth in the tumor and lots of it is aberrant growth or leads to aberrant growth. I think you could build the hypothesis that the exposure of the initial tumor to the circulatory system leads to the release of these circulating tumor cells early on. The question is when do you have enough of that burden in the blood to be able to measure it? And how do you tell the difference between those CTCs that just sort of float around and get cleaned up by the immune system and those that actually have a chance at causing metastasis at a distant site?
You start with the research questions at the patient level, and then you work backwards toward identifying the right analytical tools and the right experiments to try to answer some of these questions. And the fluid biopsy is the first step in that direction. We have now taken these tools back to test our hypotheses while simultaneously applying these tools towards direct patient care.
