Pundits have been foretelling the era of personalized medicine for some time now. Leading that charge, Genomic Health has already launched a groundbreaking genomic test — the OncotypeDX breast cancer prognosis predictor. The company did so backed by results from a major, large-scale clinical study published in The New England Journal of Medicine in 2004. It was a splashy debut, and Genomic Health plans to follow up with more breakthrough tests. Below are excerpts from a recent interview by Pharma DD editor-in-chief Malorye A. Branca with Randy Scott, CEO of Genomic Health.
Back in the mid-1990s when I was president and chief scientist at Incyte, we observed that the cost of creating and analyzing genomic data was dropping rapidly. This change was similar to what occurred when Moore’s law reduced the cost of computing, and we saw the shift from mainframes to personal computers. We saw this as the dawn of a new era in medicine — one where understanding of genomic content was ultimately going to play out at the personal level. This new era is about individuals and their healthcare.
I became obsessed with this idea, and watched as the cost of genomic analysis came down throughout the 1990s. The last straw was that I had a close personal friend diagnosed with late-stage colon cancer in the late 1990s. Walking through this ordeal with her and her husband turned into a personal inspiration. It was surprising just how little was known about her individual disease.
I realized somebody needed to do the hard work to link genomic data up to patient outcomes, and to identify markers showing who has an aggressive tumor, and whose is benign. We also needed tests to indicate response to drugs.
That led me to found Genomic Health, along with Steve Shack, Joffre Baker, Gene Early, and Pat Terry. We were all coming from different areas and yet growing increasingly excited about the concept of personalized medicine.
The approach from the start was to focus, focus, focus. To do well in business, you have to decide exactly what you will do. Everyone in our group had a passion to improve the quality of disease treatment. That’s where we saw the huge unmet need — particularly the many cases where patients have to make really tough decisions. With my friend, you just did not know what to do next. Should she do chemo? Get involved in clinical trials? What’s the right next step?
Finding a Niche
We were interested in cancer, and started looking at paraffin-embedded samples and what we could do with those. We ended up in what some might say is a really narrow niche, but we were convinced it was an enormous market, because over 100,000 women every year are affected by the decision of whether or not to have chemotherapy for breast cancer. Those treatments also cost a lot of money.
I think one advantage we had was that we weren’t in love with any particular technology. Based on experience at Incyte, we believed that while you could look at a large number of genes with microarrays, you really needed to use RT-PCR to get quantitative data, and the quality of that data is really orders of magnitude better than what you get from a microarray. That’s why our test is based on
RT-PCR.
So, instead of starting from the basis of “microarrays are cool” we started by looking at the patient’s perspective. And patients don’t care what technology you use, they just care if they get a useful answer.
Now, those answers are helping us start to understand the disease better, and that’s critical: declaring war on cancer is like declaring war on tornados. If you don’t really understand it, how can you tame it?
This is a very exciting time in this space. The path is straightforward, and we have the opportunity of really changing medicine for better.
Genomic Health just announced that its next full clinical development program will be a test to predict the likelihood of colon cancer recurrence, which is expected to build upon genes identified earlier last year in collaboration with the National Surgical Adjuvant Breast and Bowel Project
(NSABP).
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