By Kevin Davies
February 21, 2013 | Following a flagship collaboration with Foundation Medicine to provide interpretative software for genome analysis in cancer patients, N-of-One has announced a new partnership with the Fox Chase Cancer Center in Philadelphia.
Last summer, N-of-One announced at the American Society of Clinical Oncology conference that it hoped to extend its offerings directly to providers.
“We saw a need in the marketplace for hospitals to bring in comprehensive molecular programs to stay competitive,” says N-of-One CEO Christine Cournoyer. “We’ll provide the clinical genomic interpretation and therapeutic options that their oncologists need to inform treatment decisions for their patients.”
The Fox Chase partnership is, “one of the first times that a cancer center has formed a relationship for clinical interpretation, bringing this out of research and into the point of care,” she says.
By contrast with existing partnerships with Foundation Medicine and GE Clarient, which is part of N-of-One’s diagnostics business, the arrangement with Fox Chase is the company’s first direct relationship with a provider. Cournoyer says discussions with Fox Chase began last summer and continued as the center fleshed out plans to introduce the CancerCode-45 panel, which sequences 45 cancer-related genes from patient tumors.
In launching the CancerCode-45 panel last month, Jeff Boyd, executive director of the Cancer Genome Institute at Fox Chase, said: “Not every patient will benefit from this test, but for some it could very well change their entire course of treatment and significantly prolong their life.”
According to Cournoyer, N-of-One provides the third interpretative layer of a triple-deck sandwich. “We see it as a stack,” she says. “The first layer is the genome sequencing, the diagnostics platform… Second is the bioinformatics layer, which identifies the mutations and DNA markers. The third stack—what we bring to the table—is the clinical interpretation layer. We take the mutations in the molecular profile and bring out the therapeutic options associated with those mutations.”
The idea is to sell those treatment strategy reports directly to hospital providers. Fox Chase is paying N-of-One per report.
There are broad similarities between the new service for Fox Chase and N-of-One’s arrangement with Foundation. “We’re providing the link between the [tumor] sequencing and what the oncologists need,” says Cournoyer. “We’re giving them the relevant therapeutic options for that mutation, including FDA-approved drugs and clinical trials they should look at. We’re also looking at the multi-variate relationships in a given tumor.”
But while N-of-One is only analyzing data on 45 cancer genes for Fox Chase compared to more than 200 for Foundation, Cournoyer says the N-of-One is performing a deeper analysis and clinical interpretation for Fox Chase. “We provide one layer to the diagnostics companies, but a much deeper level for our providers such as Fox Chase, because those reports are intended for oncologists at the point of care,” she says.
The question of the ideal number of genes to analyze in a patient’s tumor cannot be answered as yet, the company says. “There are various discussions going on about how many clinically-actionable genes there really are,” says Cournoyer. “It’s a hard question to answer,” says N-of-One founder Jennifer Levin Carter. "At the end of the day, in terms of number of actionable genes and variants, that’s an area that everyone is looking at.”
Carter says the firm has built and curated a knowledgebase consisting of data on thousands of patients. That resource allows N-of-One to create the individualized report.
Although the curation and interpretation is largely an automated process, company oncologists also review the patient data. Cournoyer stresses, “I don’t think you can provide a therapeutic strategy [just] by pushing a button. There is some human intervention for each report,” says Cournoyer. “We will be a consultative arm for Fox Chase in terms of the literature and the clinical information that’s published and the implications of that published information. But we’re not a secondary advisory service.”
“We’re not making recommendations,” agrees Carter. “The [patient’s] oncologist is the person that determines the treatment strategy for the patient, but we do provide the supporting data that relates the molecular data to link it up to potential strategies.”
The Fox Chase partnership has gone live, and N-of-One is waiting for the first patient samples. Naturally, Cournoyer and Carter hope that will be the first of many, and stress the value their resources when it comes to “people, process and technology.”
“I can’t imagine there isn’t a hospital network that wants to go out and hire the team of scientists we have on board, create the knowledgebase we have, and support the workflow. That’s a lot of investment for a hospital system to make,” says Cournoyer.
For 2013, N-of-One will focus on expanding its oncology partnerships, but could branch out beyond cancer later on. “We’re delighted to see growth in our diagnostics business and thrilled with the growth in the provider business,” says Cournoyer. “This year we’re staying focused on cancer… but we are going to explore other disease areas.”