Paradigm for personalized medicine

ANN ARBOR, Mich.—"It's our vision to be leaders in thenation in bringing high-throughput-screening diagnostics to clinical care, tobring personalized medicine to the masses," says Dr. Jay Hess, chair of thedepartment of pathology at the University of Michigan (U-M) Medical School anda co-founder of Paradigm, a joint venture, nonprofit company for advanced DNAdiagnostics.

Hess' "partner in crime"—or more accurately in Paradigm—Dr.Robert Penny, the chief executive officer and co-founder of Paradigm andInternational Genomics Consortium (IGC), says Paradigm's mission is to "createa new paradigm to bring personalized medicine to patient care in a robustfashion." He believes that the two partner organizations have "different butcomplementary strengths" in using genetic information to understand and treatdisease that make Paradigm "greater than the sum of its parts."

Initially, Paradigm will offer services to oncologists andoncology groups, pathologists, academic medical centers and clinical trialgroups studying personalized medicine regimens. Ultimately extending into otherdisease groups, Paradigm will give doctors and healthcare organizationsanywhere access to whole-gene and multi-gene sequencing and moleculardiagnostics. The company will also help support clinical trials at theUniversity of Michigan Health System (UMHS) and other health systems.

Penny, who is launching his sixth startup company, one thathe calls the "capstone of my experience," says that his colleagues who dotranslational diagnostics advised him to contact Hess a year ago. Althoughinitially skeptical of launching a startup company with a university, Penny wasconvinced that U-M would be a good partner in responding quickly toopportunities in business development.

"U-M brings incredible breadth of intellectually successfulpeople who are accomplished and inventive," Penny says. "They've defined whatwe know about prostate cancer. They do sequencing of cancer patients and matchthem up with the best therapies and have commercialization capabilities."Paradigm complements other DNA services offered by UMHS, including the MLabsreference laboratory and the research-oriented DNA Sequencing Core.

UMHS, a 160-year-old institution for advanced patient care,research to improve human health and education of physicians and medicalscientists, includes the U-M Hospitals & Health Centers, with its threehospitals and dozens of outpatient health centers and clinics throughoutMichigan; the U-M Medical School with its Faculty Group Practice and researchlaboratories; shared administrative services; and the Michigan Health Corp. Thethree U-M hospitals have been recognized 18 years on the U.S. News &World Report honor roll of "America's BestHospitals." The U-M Medical School has total research funding of more than $490million.

Hess believes that Paradigm "allows us to harness the powerof genetic information to guide patient therapy and improve outcomes." He addsthat, "IGC has a proven track record of bringing molecular diagnostics tomarket, yet shares our nonprofit, patient-focused vision."

IGC, a nonprofit medical research organization formed byveteran genetic researchers to expand upon the discoveries of the Human GenomeProject and other systematic sequencing efforts, played a key role in compilingthe Cancer Genome Atlas, a catalog of genes known to be involved in cancer. IGCcombines genomic research, bioinformatics and diagnostic technologies to fightagainst cancer and other complex genetic diseases through standardizing thecollection of properly consented tissues of interest, as well as the molecularcharacterization of these tissues and standardization in the representation andanalysis of these results. IGC participates in the translation of genomicdiscoveries to improve patient care and increase the speed in which newdiagnostic, prognostic and predictive testing and their associated new drug andtreatment regimens are developed. It brings molecular mechanisms tocommercialization.

"Paradigm will combine our expertise in accessing evidenceand put it in a report form for oncologists when patients fail in conventionaltherapy," Hess says. He suspects that there will be many more "hybrids" ofcompanies and academia in the future and that they will deliver "a lot ofvalue."

"Together, with nimbleness and passion, we'll acceleratemore precise medicine by driving discovery and translation, getting patientsinto the best clinical trials and developing the best therapies," Pennyconcludes.

The company, which launched in August, expects to have testsavailable by January 2013.