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A solid foundation for personalized medicine
CAMBRIDGE, Mass.—Foundation Medicine Inc., a personalized cancer medicine company that aims to bring comprehensive cancer genome analysis to routine clinical care, will collaborate with Novartis to develop, enhance and optimize Foundation's cancer genome panel test for Novartis' needs.
If the pilot phase is successful, Novartis and Foundation Medicine will evaluate opportunities to collaborate on the production and commercialization of the test. Financial details of the agreement were not disclosed.
In a joint statement, Novartis noted that it became aware of Foundation's expertise in sequencing from existing Novartis Institutes for Biomedical Research (NIBR) collaborations, and as a result, decided to implement the partnership.
Foundation was launched with the assistance of a team of academic advisors from the Broad Institute, the Dana Farber Cancer Institute, Harvard Medical School and the Massachusetts Institute of Technology, and is backed by Third Rock Ventures, a life sciences venture capital firm. Alex Borisy, formerly an entrepreneur-in-residence at Third Rock, founded Foundation and was named CEO in 2010.
Foundation is focused on developing clinical laboratory tests—using next generation sequencing and other advanced technologies—that will broadly analyze the relevant tumor genomic and other molecular information present in individual patients' cancers.
The results will be delivered to oncologists in an easily accessible, as yet unspecified, format, "within the context of a growing knowledge base of published clinical data to help oncologists personalize treatment," the company states.
As of now, Foundation's cancer genomics laboratory tests are in development and not yet available for clinical use.
According to the joint statement, "It is too early to speculate on specific timing, but we anticipate being able to complete the evaluation of Foundation's current approach by the end of 2011. The value of the Foundation Medicine test is that it will be relevant to all cancer types and the entire Novartis oncology portfolio."
Apparently, Foundation expects its technology and tests to require changes in regulatory policies and approaches.
"The transformation toward personalized cancer medicine will not be simple; many scientific and technical hurdles must be crossed before we realize our vision. The business, regulatory and public policy issues that must be addressed are challenging, too.
"For example, will the United States' patent system (and other national and multinational patent organizations) remove barriers that impede the equitable provision of new genomic and other molecular diagnostic tests? Will the Food and Drug Administration (and its sister organizations around the world) modify or clarify regulations and policies to accommodate the new world of personalized medicine? Will Medicare, Medicaid and private insurers reexamine evidentiary and other reimbursement preconditions, so that personalized cancer care becomes available and accessible to all patients? Genomic medicine has the capacity to revolutionize cancer care, but if these business, regulatory and public policy issues are not adequately addressed, the transformation in cancer care will be slowed," the company cautions.
"This pilot collaboration with Novartis represents our first pharmaceutical partnership, and we are delighted to accomplish this important milestone with one of the world's leading cancer therapeutic companies," Borisy says. "As part of this agreement, Foundation will leverage the broad contents and high quality of our cancer genome analysis platform. By delivering a clinical-grade analysis of molecular information, Foundation's dedicated clinical research team will help our partners more rapidly translate novel findings into therapeutically applicable results. This collaboration is an important step forward for Foundation and could provide us with the basis for building successful cancer genome analysis platforms for future collaborations and partners."