The University of Michigan and the International Genomics Consortium have created a non-profit company called Paradigm that will provide a molecular diagnostic service to guide personalized treatment for cancer and, eventually, other diseases.
Paradigm will accept patients' biological samples from doctors or hospitals and analyze them with targeted sequencing. Following this analysis, the company will produce a report that explains which targeted therapies might be linked to a patient's particular mutations.
Jay Hess, chair of the Department of Pathology at the U-M Medical School and a co-founder of Paradigm, told PGx Reporter that the company expects to launch this service by next year.
Hess said the first product the company will offer is a sequencing panel comprising approximately 200 genes. He declined to detail the specifics of the technology underlying the panel, but said that the turnaround time from conducting the analysis to producing test results for doctors would be "on the order of days, not weeks."
According to Hess, Paradigm will only report on markers that have a high level of evidence and will indicate in its reports to doctors the types of data supporting the markers' link to drug response.
"For example, if you are a patient with pancreatic cancer and you have a KRAS mutation, what does that mean in terms of what kind of therapeutic options you have?" he said. "A lot of what Paradigm [will do will not be] just the sequencing, but how [we] build a report oncologists can use, that provides qualities or levels of evidence for a particular pattern of mutations … to direct you toward a particular therapy."
"That's really the key," he said.
Parallel to this, the company will also seek to use its sequencing and analysis service to support clinical trials, especially at U-M.
"We will work with clinical research organizations and pharmaceutical companies to provide molecular diagnostics to support clinical trials," Hess said. He could not mention any potential planned trials, but said Paradigm is talking to several interested parties.
According to Hess, the project will retain its non-profit structure for the long haul. "This is not something we're going to try to sell in three years," he said.
Hess also said the group is agnostic with regard to sequencing technology. Though Paradigm already has a quick-turnaround sequencing platform chosen, he said the team has "tried to keep our distance from the different instrument makers" in order to leave open the possibility of changing platforms in the future.
Though he did not provide details about the sequencing approach or other steps in the team's analysis process, Hess said that the "added value" will be in the report to physicians. "We are very concerned about doing this responsibly and not over-reaching," he said, "so all our algorithms for analyzing data are completely validated."
Sequencing and analysis will be conducted in a CLIA-certified lab, he added.
There are a number of other groups offering molecular analysis to help tailor cancer treatment to a patient's genomic profile, and most of them are following a for-profit model. Foundation Medicine, for example, recently launched a sequencing-based test that sequences the exons of nearly 200 genes known to be mutated in solid tumors and provides a report informing doctors of actionable mutations.
Another firm, Intervention Insights, announced last year that it was planning to grow its "OncInsights" service, which provides a searchable online report matching a patient's gene-expression profile to actionable therapies. (PGx 8/27/2011)
Robert Penny, Paradigm's co-founder and IGC's CEO, is actually the co-creator of another PGx service, TargetNow, currently offered by Caris Life Sciences, which acquired it in 2008. TargetNow is a "platform agnostic" system that uses several technologies to profile a patient's tumor for a variety of biomarkers. (PGx 9/14/2011)
Hess called the Paradigm service a "more sophisticated" version of what Caris provides.
He also said the goal is for Paradigm to eventually expand beyond cancer to other diseases as well. Though there are no solid plans for what disease areas the company might target next, he said cardiomyopathy and deafness are some areas where genetics may provide real value.