Jennifer Levin Carter, MD, MPH is Founder and President of N-of-One. A board-certified internist and entrepreneur, she has more than 20 years of experience evaluating existing and emerging markets, new medical technologies, and early-stage companies in the health-care field. Formerly, Dr. Carter was a consultant and analyzed biotechnology, pharmaceutical, and medical device firms on behalf of investors. She received an MD degree from Harvard Medical School and a Master’s degree in Public Health from The Harvard School of Public Health.
Like other diagnostic labs that provide additional content with the results of their testing, N-of-One uses data from a patient’s tumor molecular profile to generate reports that help physicians and patients identify optimal diagnostic and treatment strategies. Recently, The ASCO Post spoke with Dr. Carter about her company.
Project Origins
What led you to start this company?
After training as a physician, I worked in biotech and medical technology and I saw first-hand how the incredible advances of the basic science in cancer biology were ready to be applied clinically. But I also saw how many clinicians and patients struggled when they tried to access, interpret, and manage this complex web of evolving information at the point of care. N-of-One was founded to bridge this gap.
The Process
What is your approach to identifying a personalized treatment strategy for the patient with cancer?
Our scientific team gathers clinically relevant information for an individual patient and generates a list of molecular tests that are specific to that patient’s cancer. We use a proprietary database, called MarkerMine, as in mining data. The database is comprised of several years of annotated data and is constantly updated. The clinical team then oversees all the logistics required for molecular testing. Once all the data from testing are back, we analyze the results with expert opinion provided by our network of clinicians. Based on the aggregated molecular data, our scientific team compiles an individualized Treatment Strategy Roadmap, outlining potential treatment options, including information on FDA-approved therapeutics and drugs in clinical trials.
Costs and Finances
Does insurance pay for your services?
Some parts are covered by insurance and some parts are an out-of-pocket expense. N-of-One identifies and manages the cost structure for patients and physicians, and customizes programs to fit their needs. We’re in the process of establishing collaborations with medical practices and community cancer centers to accommodate them.
How is the company supported other than through user fees?
We’ve been expanding our business beyond the direct-to-patient business over the past 18 months. We now have a significant segment of our business that is based on the interpretation of molecular test results for several large diagnostics companies, and this represents hundreds of reports per month. Presently, we are bringing our capabilities to large heath-care networks and are helping them to implement a comprehensive molecular diagnostics and treatment programs. We believe this segment will become the largest portion of our business.
Is there any conflict of interest in terms of tests you recommend?
We’re agnostic in terms of particular testing providers and technologies. Our goal is to outline the tests with the highest impact for the treating physician. As the field changes, we keep pace with the most relevant testing resources.
Collaborative Efforts
How do you interact with institutions?
Because we take a data-based approach to molecular medicine, we collaborate with academic partners throughout the country. Our goal is to become a natural partner for any group that is trying to provide cost-effective, efficient genomic profiling for individual patients. There is incredible fragmentation in the system—different institutions offer different tests and clinical trials. N-of-One is creating an infrastructure to make molecular medicine available across institutions, by ensuring that physicians and patients, regardless of where they are, know what the best test is, where to get it done, and how this relates to therapy.
How are your data being used?
We are looking for opportunities to collaborate and share the outcomes of our work. Interaction with the entire health-care community is crucial to moving the field of individualized medicine forward. Precision medicine requires careful assessment of efficacy in order to ensure that appropriate patient groups are being offered access to key drugs. As more data about markers in different disease types are collected, it’s important to ensure that all outcome data generated in the field are available to the broader academic community.
Clinical Trials
You also suggest clinical trials as part of your personalized strategies?
Yes, matching the patient to the appropriate targeted medicine is an important aspect of the N-of-One approach. Many of the drugs currently in development are targeted treatments. This past year has been phenomenal in terms of the numbers of new targeted treatments approved by the FDA. Appropriate genetic selection of patient populations will become the standard in future clinical trials and will help expedite targeted drug development. ■
Disclosure: Dr. Carter is founder and president of N-of-One.
