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N-of-One to Provide Interpretation Reports to Physicians for Fox Chase's CancerCode45 Test

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Fox Chase Cancer Center has contracted genomics interpretation company N-of-One to interpret and curate results from its new targeted sequencing-based test, CancerCode45, creating reports for ordering physicians that link genomic findings with potential targeted therapies.

The company's reports will pick out and highlight mutations identified by the test that are associated with specific cancer drugs and explain the research behind these links to help doctors at Fox Chase personalize treatment strategies for their patients.

The FCCC debuted its test — which relies on an adapted version of Ion Torrent's AmpliSeq cancer panel to sequence 45 target genes known to harbor mutations associated with prognosis or targeted treatments — in mid January, PGx sister publication Clinical Sequencing News reported (CSN 1/16/2013). But the center didn't disclose at the time that it had contracted with an outside interpretation and reporting service.

Fox Chase's Jeff Boyd told PGx Reporter this week that the center learned about N-of-One's product as it built out its cancer genome institute and the CancerCode45 test.

"We vetted the product with [our advisory team] and spoke to our medical oncology team … and there was really no reason to look around. It was exactly what the doctors here were looking for," he said.

"This [reporting] is really not a trivial task," Boyd added. "Especially if your goal is to remain current, and if you are talking about early phase trials, it can literally be different one day to the next."

Given the rapidly evolving nature of the genomics field, what drew Fox Chase toward N-of-One is the fact that the company is constantly updating its interpretation and analysis capabilities. This is "something we just would not be in a position to do," Boyd said. "They provide [this] at far less of a cost than would be required for us to create the infrastructure to do it ourselves."

Christine Cournoyer, N-of-One's CEO, told PGx Reporter that the company's service is based on what it calls its PrecisionWorks framework, a "proprietary curation and editorial process" backed by a database the company calls MarkerMine.

"We've done thousands of clinical interpretations so we have a very robust database and on a daily basis, experts are curating new information into the system," Cournoyer said.

In addition to contracting with academic and hospital centers, like Fox Chase, for interpretation of specific genomic tests, N-of-One also offers a direct service to patients and their doctors in which it coordinates molecular testing, interpretation, and treatment decisions. "Over 50 percent of our patients are referred by their oncologist to come to us," Cournoyer said. The company also has commercial clients in Clarient and Foundation Medicine. With Clarient, it co-developed a website, www.ismycancerdifferent.com, that informs cancer patients about emerging molecular tests and targeted treatments. In its work with Foundation, it is applying its PrecisionWorks platform to help the company provide individualized patient reports.

For Fox Chase, N-of-One is taking mutation information from the CancerCode45 pathology report and using its framework to create a report linking mutations to potential targeted treatments. It then sends the report back to the center, which distributes it to ordering physicians.

"Our pathology report has a lot of detail in it that, frankly, the medical oncologists don’t have the time or inclination to go through," Boyd said. "So what N-of-One does is take that sort of crude pathology report and give back a nice polished summary of any mutations found and any sort of drugs that would be matched to that mutation in either an FDA-approved fashion, or off-label for something in the pipeline, [and] clinical trials that would be amenable."

Cournoyer and Jennifer Levin Carter, N-of-One's founder and chief medical officer, said that N-of-One distinguishes itself from other molecular profiling and targeted therapy reporting tools by both its flexibility and its clinical depth.

According to Levin, other services to guide targeted personalized drug therapy are often wedded to a particular technology or group of technologies. Because N-of-One doesn't actually do its own molecular or genomic testing, it is able to truly work "across any diagnostic platform," Levin said.

Boyd added that what is particularly valuable for Fox Chase is the fact that N-of-One's reports will provide a citation section that lists the evidence behind each drug link.

"They simply distil the literature for you, and a physician uses his or her best professional judgment based on that information," he said.

According to Cournoyer, the reports do not offer treatment recommendations or a ranking of different potential treatment strategies based on the evidence behind them. "We just provide the clinical evidence," she said.

Boyd said last month that Fox Chase's CancerCode45 test is not currently reimbursed by insurance companies, but that the center is "working diligently with [payors]" to try to get there.