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N-of-One Launches Oncology Informatics Platform, Announces Partnership with Foundation Medicine

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Emerging from stealth mode this week, oncology informatics startup N-of-One launched PrecisionWorks, an analysis platform intended to help physicians and patients make informed decisions about cancer treatment strategies.

Jennifer Levin Carter, the Waltham, Mass.-based company's president and chief medical officer, described the platform as a tool that "integrates all the core elements needed to translate the ... data-intensive realm of molecular targeted research, diagnostics, and treatment into actionable clinical information that physicians and patients can access on a daily basis."

These elements include a molecular knowledge database called MarkerMine; proprietary software for mining molecular data and analyzing data from individual patients in the context of larger datasets; and analytic capabilities for synthesizing different types of information such as molecular, genomic, patient, therapeutic, diagnostic, and population data. The PrecisionWorks platform also includes a logistics management system that handles coordination among healthcare providers, diagnostic companies, payors, drug companies, and patients, N-of-One said.

The company announced this week that is has tapped Christine Cournoyer to serve as its chief executive officer. It also announced a partnership with Foundation Medicine under which it will provide analysis services for the company's FoundationOne sequencing-based cancer test.

N-of-One's platform provides oncologists with so-called "diagnostic strategy and treatment strategy roadmaps" that are based on information in MarkerMine.

Diagnostic strategy roadmaps identify relevant biomarkers to be evaluated in each patient’s specific tumor type by analyzing the patient's disease history as well as the scientific and medical literature. The company uses this information to generate an individual biomarker profile for the patient that is likely to help the physician assess potential treatment strategies.

After presenting suggested diagnostic options to physicians, the company also helps coordinate testing at CLIA-approved diagnostic laboratories.

Carter explained that once a diagnostic approach has been selected, the company's scientific and medical team helps physicians select an appropriate testing facility by evaluating potential diagnostic labs based on parameters such as quality and transparency as well as the type of testing the patient requires.

After a molecular diagnosis has been made, the firm then offers the physician and the patient treatment strategy roadmaps that link biomarkers identified in the patient's tumor to targeted therapies that may be effective against the specific cancer. These strategies are developed within the context of the individual’s other known molecular alterations as well as relevant disease history.

N-of-One also provides a clinical trial matching service for patients that connects them to appropriate clinical studies by matching each individual's molecular variants to clinical trials involving therapies that target these alterations.

The firm also helps diagnostic companies generate molecular integration reports, which provide information on molecular variants identified by diagnostic tests in a "clinically relevant" format.

The MarkerMine database houses information from published literature and other publicly available data resources that is evaluated and curated by the company's scientific team before being included in the resource, Carter said. The firm also consults a network of scientists and oncologists to "tap into research and new ideas" that "enhance" the information contained in MarkerMine, she said.

In its collaboration with Foundation Medicine, N-of-One will use PrecisionWorks to link molecular variants identified by the company's test to information about relevant targeted therapies and clinical trials that could be effective against individual patients' tumors.

Foundation Medicine will then provide this information as part of a report to oncologists who use it in their efforts to select the most tailored treatments for their patients.

Foundation Medicine's FoundationOne test, also launched this week, is a targeted sequencing-based assay that screens for mutations in more than 200 cancer-related genes. The test runs on the Illumina HiSeq 2000.

Kevin Krenitsky, Foundation Medicine's chief operating officer, said in a statement that N-of-One's platform helps his firm translate data from the test "into information that can be provided to clinicians to help them understand and act upon the genomic data we provide."

N-of-One was founded in 2008. The company initially focused on developing a direct-to-consumer solution that patients themselves could use to obtain information about cancer diagnostic and treatment approaches.

"We started off working with individual patients and learning about what solutions would be most useful and how to package them up for higher-throughput access and use," Carter explained to BioInform.

"We really wanted to take a very incremental and careful approach to understanding what the needs of the various stakeholders were and how to implement a solution that was really successful and sensitive to the requirements of each of the individual stakeholders in the system," she explained.

According to Carter, the company found that healthcare providers struggled to keep up with rapidly changing technologies, new treatments, and growing quantities of data.

Four years later, the company believes that it "understand[s] the needs of the market" and that with PrecisionWorks, it has created a "systematic approach that allows us to offer the platform infrastructure and solutions to meet the needs of oncologists, regional cancer centers, provider networks, and diagnostic companies that are focused on delivering the personalized cancer care," she said.

N-of-One is looking to expand its 16-person headcount, CEO Cournoyer told BioInform.

Specifically, the company is looking to add to its science and oncology team as well as to its executive team, she said.

While there are a number of informatics vendors looking to stake a claim in the diagnostic marketplace, the company believes its fee-based services business model is unique.

According to Cournoyer, while other companies in the space either have more of a "pure services play and a consulting approach" to the market or offer software, "we are in the middle," she said.

"We are not going to market as a software solution strictly ... we don’t think this is simply informatics; we can't just push a button and get therapeutic strategies for complex diseases like cancer," she said, adding that providing physicians and patients with access to molecular information "requires a combination of both a software knowledge content play as well as a team of very skilled trained researchers, scientists, and oncologists."

One company that could give N-of-One a run for its money is IBM, which recently announced a partnership with Memorial Sloan-Kettering Cancer Center to apply IBM's Watson artificial intelligence technology to cancer diagnosis and therapy selection.

IBM told BioInform earlier this year that it hopes to launch a system next year — tentatively dubbed Watson Enabled Diagnosis and Treatment Adviser for Oncology — that will integrate patients' clinical information, molecular and genomic data, and clinical oncology practices from the literature in order to advise medical professionals on the best treatments for their patients (BI 4/6/2012).

IBM Research is also working on a separate platform, called Clinical Genomics, or CL-G, that combines a patient's genomic information and clinical data to make personalized treatment suggestions. The system, developed by researchers in IBM's Haifa, Israel, branch, is currently being tested by researchers at Italy's Fondazione IRCCS National Cancer Institute who are using it to analyze data from patients with sarcoma and head and neck cancers (BI 3/16/12).

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