N-of-One Names CEO, Forms Pact With Foundation Medicine

5/31/12Follow @arleneweintraub

Waltham, MA-based N-of-One announced today several milestones in its quest to provide tools that can help oncologists design personalized treatment regimens for their patients. The company, founded in 2008 by Harvard-trained physician Jennifer Levin Carter, formed a partnership with Boston-based Foundation Medicine to transform genomic data from individual cancer patients into treatment strategies. N-of-One has also recruited a new CEO, Christine Cournoyer, who was formerly the chief operating officer of Picis, a health IT provider that was purchased by United Healthcare in 2010.

The genesis of the idea for N-of-One came from Levin Carter, who spent 20 years as a consultant to the drug and medical device industries. During that time, she saw huge advances being made in the understanding of how specific therapies could be tailored to patients based on their genetic profiles—but little ability for physicians to actually put that information into practice. “I could see this incredible fragmentation in the system,” she says. “There was no infrastructure to allow data to flow directly to the clinic.” The problem hit close to home in 2002, when a family member and two close friends died of cancer, Levin Carter says. “Trying to help them access the treatments they needed made me even more aware of this fragmentation.”

N-of-One has spent the last few years fine-tuning its strategy, which combines data analysis with personal consulting services to help cancer patients and doctors zero in on the right treatment strategies. A new informatics product that the company launched today, called PrecisionWorks, identifies tumor biomarkers—molecular signatures that have been pinpointed as important for guiding treatment decisions—and helps patients get the proper tests to determine whether or not they carry those markers. Once the test results are in, PrecisionWorks links them with information about targeted therapies and clinical trials that are most appropriate for patients, in the context of each individual’s genetic profile and disease history.

Foundation Medicine said today it will apply PrecisionWorks to enhancing its technology, which uses DNA sequencing to analyze tumors for alterations in more than 200 cancer-related genes. The companies plans to use N-of-One’s platform to match the molecular variations that are identified with the latest information about relevant therapies, so oncologists can tailor treatments to patients based on their genomic profiles.

N-of-One has raised about $5 million from a group of individual investors, some of whom approached Cournoyer last fall and asked her to do some due diligence on the company. Cournoyer says she was so intrigued with the technology she agreed to join the board and then to take over as CEO. “I’ve spent the last five or six years selling electronic health records to large, integrated hospital chains, and I’ve seen the tremendous cost pressures they’re facing,” Cournoyer says. “N-of-One has developed a cost-efficient way to provide oncology strategies.” Cournoyer says N-of-One will strengthen its efforts to sell PrecisionWorks not only to individual physicians, but also to hospitals and oncology-treatment centers.

The company is playing in what’s increasingly becoming a crowded market for personalized-medicine technology. In March, New York-based MolecularHealth—founded by SAP founder Dietmar Hopp—debuted its software platform, which also uses genomic data to provide oncologists with information to help them develop tailored treatment strategies.

Cournoyer says N-of-One is different because it doesn’t just hand its technology over to physicians and expect them to figure out how to use it. Rather the company works with physicians and patient-care teams to make sense of the data, and it provides supportive services, such as logistics management systems that help coordinate patients’ interactions with healthcare providers, diagnostic companies, insurers, and drug companies. “Companies like Molecular Health are taking a very automated approach to providing oncologists with options,” Cournoyer says. “We don’t think you can push a button and come up with a treatment strategy for cancer. Our knowledge base combined with our team is our differentiation.”

The company declines to provide details on its financial situation, though Levin Carter says it is deriving revenues from several sources, including provider groups, individual patients, and partners such as Foundation Medicine.

Levin Carter, who now serves as N-of-One’s president and chief medical officer, says the company hopes to find more partners who are interested in leveraging the increasing pile of data on how genomic variations affect cancer care. “We are looking for other partnerships in what I call the personalized medicine ecosystem—laboratories, provider groups, patient groups, drug companies, payers,” she says. “These are all important stakeholders in the success of personalized medicine.”

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