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N-of-One Analyzes 4,000th Tumor

By Allison Proffitt 
August 26, 2013 | N-of-One Therapeutics has analyzed and interpreted its 4,000th cancer patient tumor, providing details on therapeutic options beyond the current standard of care in more than 70% of cases. 
“That clinical interpretation has gone to thousands of oncologists with clinically actionable results,” said Chris Cournoyer, N-of-One’s CEO. “We’re providing the oncologists with the knowledge of the molecular drivers of the specific patient’s tumors, as well as the therapeutic options available to treat that tumor. It’s really valuable clinical information.” 
The Waltham, Mass.-based company was founded in 2008, and has a team of 30 Ph.D. scientists, physicians, and technologists. 
N-of-One delivered 1,830 reports last year and Cournoyer expects that number to more than double this year with orders from existing partners and new ones—2013  year to date has seen 2,237 report. She predicts “exponential growth” in 2014. “We see precision medicine being widely adopted across a growing number of physicians,” she said. 
N-of-One’s clinical interpretation is performed across 347 different cancer subtypes including solid tumors and hematologic malignancies.  
“Reports synthesize the relevant scientific and clinical information that our team of scientists curate every single day they receive mutations,” Cournoyer explained. “They’re curating the scientific and clinical information about that mutation in that disease and providing to the physician what are the molecular drivers of that tumor, and they’re also providing the therapeutic options to treat that particular mutation in that specific tumor. It’s very tailored to the tumor that we’re analyzing.”
N-of-One delivers their product through partnerships with Foundation Medicine, Fox Chase Cancer Center, CROs and other groups. “Our relationship with Foundation Medicine is a great example of how we have historically been able to get our clinical interpretation of molecular diagnostics tests into the hands of thousands of treating physicians,” Cournoyer said.
But for a couple of hundred cases, N-of-One has direct contact with patients who are referred by oncologists, and has been able to follow those patients closely. 
In those cases, says Jennifer Levin Carter, Chief Medical Officer of N-of-One, “About 35% of treating physicians will make an immediate change to their therapeutic strategy once they see the clinical interpretation that we provide.” 
In some cases, N-of-One suggests clinical trials to patients. “The clinical trial enrollment rates that we’re seeing are much higher [than national averages],” Carter says. “First of all, we’re able to identify through this interpretation, relevant clinical trials, based on a patient’s molecular profile in about 96% of the interested patients that we were able to follow. Enrollment rates in that cohort were 38%... and that’s significantly above the national average of about 3%.” 
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