BY JUDY O’ROURKE, EDITOR, CLP
N-of-One Inc, Waltham, Mass, analyzes the molecular profile and mutations shown through genome sequencing of a patient’s cancer. The company generates a biomarker profile whose diagnostic analysis is aimed at delivering comprehensive treatment strategy profiles.
The company provides the profile for testing at CLIA-approved diagnostic labs.
Following on the heels of of recent news that the company partnered with Fox Chase Cancer Center, Philadelphia, to offer molecular interpretation and treatment strategy analysis for Fox Chase patients who are undergoing DNA sequencing with CancerCode-45, which sequences 45 cancer-related genes in a patient’s tumor, CLP spoke with Christine Cournoyer, CEO, N-of-One, to learn more.
CLP: Can you tell us some of that labs that are performing the testing?
Christine Cournoyer: There are a number of labs that perform high-quality molecular diagnostic testing in a CLIA-approved setting. Examples of these include Clarient/GE Healthcare, Integrated Oncology, Knight Diagnostic, Foundation Medicine, Caris, and others. In addition, some very good CLIA labs are located at academic cancer centers.
CLP: After your experts analyze the diagnostic testing results on the priority molecular biomarkers, you formulate a treatment strategy plan. What advanced technologies, besides next-generation sequencing, are used?
Cournoyer: In many instances, mutational analysis is insufficient to provide a complete description of the tumor’s profile and additional in-depth analysis is required. Mutational analysis does not fully cover the range of possible therapeutic targets and in many tumors, mutational analysis alone does not yield actionable data. Analysis of other aspects of the molecular biology of the tumor frequently reveals additional therapeutic possibilities. This can include biomarker expression analysis, gene copy number analysis, proteomics platforms, serum analyses, and circulating tumor cells. N-of-One regularly evaluates and integrates novel and evolving strategies related to oncology diagnostics.
CLP: What differentiates your clinically relevant reports?
Cournoyer: Our reports are unique because they provide the treating oncologists with the knowledge and data required at the point of care to understand the clinical relevance of the molecular testing and how the molecular data is linked to additional therapeutic options for their patient, including FDA-approved therapies and drugs that are in clinical trails. All knowledge is highly analyzed and curated by our talented team of scientists and oncologists and can integrate any type of molecular testing.
CLP: Can you tell us some of the diagnostic companies that are partnering with N-of-One to improve the usefulness of their reports using N-of-One Biomarker Insights reports?
Cournoyer: We’re pleased to say that we have an excellent partnership with Foundation Medicine where we’ve interpreted thousands of reports, providing them with the clinical interpretation and insights needed by the ordering oncologists.
We also have a strategic partnership with Clarient, a leading diagnostics company that is part of GE, and we provide them with the clinical relevance of the mutations they have tested for some of their clients.
N-of-One has formed a partnership with Fox Chase Cancer Center, Philadelphia, part of the Temple University Health System Philadelphia, where it will offer molecular interpretation and treatment strategy analysis for genome sequencing and testing performed for advanced-stage cancer patients through the Cancer Genome Institute at Fox Chase.
CLP: How will your experts tap into N-of-One’s database to develop treatment strategy plans for Fox Chase patients—is it a form of data mining? And, how do you enhance, but not duplicate, the expertise provided by the Cancer Genome Institute at Fox Chase?
Cournoyer: With Fox Chase, we are working with their talented bioinformatics team who will interpret the big data from the sequencing machine and provide us with the variants to be interpreted. The N-of-One team, leveraging our Precision Works framework, will provide the clinical interpretation of the genetic findings that allows physicians to have knowledge of expanded treatment options available through personalized medicine.Our approach is a unique blend of curation and expert interpretation driven by our scientific and oncology team.
CLP: How will expertise and informatics help the Cancer Genome Institute at Fox Chase attract more patients and expand its program?
Cournoyer: We are seeing a growing need for hospital systems to stay competitive by offering molecularly specific cancer care. Fox Chase is a leader in bringing molecular sequencing to the point of care, which should attract cancer patients seeking advanced molecular diagnostics and treatment programs.
CLP: How can your platforms interface with data from any sequencing platform, diagnostic, or bioinformatics system?
Cournoyer: We are agnostic to the diagnostics platform and can incorporate data from any diagnostics platform that a hospital system is using into our PrecisionWorks framework.
CLP: How does N-of-One coordinate the process of providing patients with personalized cancer care (providing coordination among health care providers, diagnostic companies, drug and technology innovators and payers)?
Cournoyer: Our mission is to provide oncologists and patients with the most current knowledge of the molecular characteristics of the patients’ tumor and to provide therapeutic options available for treatment. We provide this knowledge through three channels; our direct client business which is self-pay patients often referred by their oncologists; our diagnostics business with strategic partnerships with leading labs; and our provider business, which allows health care systems to quickly and cost-effectively deploy a comprehensive molecular program leveraging N-of-One services.
CLP: Please decode the company’s name.
Cournoyer: The letter N is the number of subjects in any study. N-of-One technically means a clinical trial in which the entire trial is one person. It is about bringing the best treatment options to each individual based on that specific individual’s tumor molecular profile.
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For more information, contact Editor Judy O’Rourke at firstname.lastname@example.org