Cancer diagnostics company Foundation Medicine has signed deals with four pharmaceutical companies this year, allowing those companies to use its clinical cancer genomic test. In early 2011, Foundation inked deals with Novartis, Celgene, and an undisclosed company, and it recently signed a similar deal with Johnson & Johnson Pharmaceutical Research and Development. Foundation Medicine's test uses next-generation sequencing to analyze small formalin-fixed, paraffin-embedded tumor samples, and checks for mutations in more than 200 cancer-related genes.
"I think Foundation Medicine has really struck a chord with pharma because they're using our test to better understand the molecular basis of their clinical trial participants' cancer. They are using it to stratify patients for longitudinal studies, to evaluate individuals that have a recurrence, to evaluate individuals that have adverse reactions," says Foundation CEO Michael Pellini. "It's all about patient stratification, and we've become very adept at applying this type of technology to cancer tissue." The companies are also using the test to go back and evaluate trials that missed their clinical endpoints to determine if there's a sub-population of patients that would make for a more targeted follow-on trial, he adds.
In addition to the revenue from the collaborations — Pellini did not disclose the financial terms of the deals — there are other benefits to working with the pharmaceutical companies. Foundation — which expects to launch its test commercially in mid-2012 for use in the clinic and achieve CLIA certification of its lab by the end of 2011 — will gain insight into pharma companies' pipelines to make sure the test is as comprehensive as possible, Pellini says. "We have access to the data for the development of companion diagnostics, which is something that's very important to us. We have no interest in the rights on the therapeutic side, but we have an interest to use the data on diagnostic development, which is really complementary to what pharma is doing," he adds.
Eventually, when the test does go to market, Pellini says, Foundation hopes it will guide therapeutic decision-making. "This type of testing does enable personalized medicine, and when you have a therapeutic that is targeted to a very specific molecular profile, and the only way to determine that profile is through the testing that Foundation Medicine does, I think it's fair to say that we enable personalized medicine," he adds.