Co-founded by Mayo Clinic, OneOme is a Minneapolis, Minnesota-based precision medicine company focused on bringing high-quality pharmacogenomics (PGx) into patient care. We truly believe that PGx holds the potential to make a positive, appreciable difference in the lives of patients, and we work closely with our partners to help realize these benefits across the healthcare ecosystem. The OneOme team is guided by our vision, mission, and company values. These are more than words in an employee handbook, they are the principles that drive our decisions and shape our organizational strategy.
As a leader in the pharmacogenetics (PGx) space, OneOme believes this is a positive step toward achieving consensus evidentiary standards for PGx testing. Our intent in providing the following comments was to help move toward this consensus by offering constructive feedback using our team’s extensive experience in evaluation of PGx evidence and our practical knowledge of how clinicians use PGx testing in patient care.*
OneOme appreciates FDA's move to further precision medicine as well as the opportunity to review and provide feedback on the Table of Pharmacogenetic Associations. The following comments are intended to promote development and consensus around evidentiary standards and best practices in pharmacogenomics ("PGx").
Phenytoin (PHT) is metabolized by CYP2C9. Studies have associated the *3 allele with increased risk of severe cutaneous adverse reactions, particularly in patients of Chinese and Thai descent. Poor CYP2C9 metabolism of phenytoin is associated with increased plasma concentrations and probability of toxicity. The Clinical Pharmacogenetics Implementation Consortium (CPIC) and Dutch Pharmacogenetics Working Group (DPWG) have published specific guidelines regarding this association.1,2 In addition, CPIC, FDA, and the Canadian Pharmacogenomics Network for Drug Safety (CPND) noted that presence of the HLA-B*15:02 allele is associated with the risk of developing Stevens-Johnson Syndrome (SJS)/Toxic epidermal necrolysis (TEN).1,3,4 The high frequency of HLA-B*15:02 in Chinese, Thai, Taiwanese, and Indonesian populations (4%-36%) means it is important to note the risk of PHT-associated SJS/TEN in patients carrying this allele.
FDA presented three tables, describing only the first as being supportive of therapeutic management recommendations. The rationale and practical implications of FDA's categorical divisions are unclear at the outset and become more so when, for example, citalopram and escitalopram are categorized separately, in Tables 1 and 3, respectively.
Citalopram is a racemic mixture in which the S-enantiomer, escitalopram, is the active component (167x more active than the R-enantiomer4) and favored target of CYP-mediated metabolism (CYP2C19, -3A4, and -2D6).5,6 Given the adverse drug event (ADE) and efficacy data available for citalopram, the pharmacokinetic data alone, which FDA acknowledges by inclusion of escitalopram in Table 3, should be sufficient to support the use of CYP2C19 PGx in therapeutic management with escitalopram and thus its inclusion in Table 1. The FDA tables also note only the likelihood of increased systemic drug concentrations in poor metabolizers but ignore the substantial data available indicating the likelihood of reduced systemic drug concentrations and lack of efficacy in rapid and ultrarapid metabolizers (carriers of CYP2C19*17).2,7-9
The confusion lies with the implication that the contents of Table 3 have less supporting evidence than those in Table 1. The case of citalopram/escitalopram belies this demarcation, because the racemic mixture of R and S citalopram is comprised of 50% escitalopram. Given the level of data supporting increased ADE risk with the racemic mixture demonstrated by FDA's inclusion of citalopram in Table 1, additional in vivo studies of escitalopram would unnecessarily expose human subjects to increased risk without demonstrable benefit.
As FDA works on future drafts of the Table of Pharmacogenetic Associations, OneOme offers the following recommendations:
*Note: Due to commenting platform constraints, the comments presented here include minor changes to formatting. References have also been included as part of the comments rather than listed in a separate reference sheet as they are on the docket.
CLEVELAND and MINNEAPOLIS, Dec. 2, 2019 /PRNewswire/ -- Family Care Path, Inc. a health technology company that brings applications benefiting people to the healthcare market, today announced a new partnership with Minneapolis-based pharmacogenomic (PGx) solutions company, OneOme, LLC. Through this partnership, Family Care Path will be offering OneOme's RightMed® Test to its customers along with its MyLegacy application, a family history-based genetic risk assessment.
PGx is the study of how DNA may affect an individual's response to medications. OneOme's RightMed Test is a PGx test, co-developed with Mayo Clinic, that analyzes a person's DNA to give doctors and pharmacists genetic information that may help them optimize medication selection for that person, minimize trial and error in the prescribing process, decrease the likelihood of adverse drug reactions and reduce potential healthcare costs. And only individuals most likely to benefit from pharmacogenomic testing will actually be tested, using OneOme's proprietary population evaluation algorithm.
"OneOme's RightMed Test is an ideal complement to our MyLegacy application," said Dave McKee, President and CEO of Family Care Path. "This partnership brings a new and exciting dimension to our offering, while maintaining our focus on improving people's health outcomes while reducing healthcare costs."
My Legacy is a web-based application that collects, through a secure web-based portal, an individual's personal and family health history information to evaluate their genetic risk for actionable conditions. This allows for preventative healthcare before the person develops significant and potentially devastating diseases like cancer or cardiovascular disease. And by addressing the disease at this earlier state, provides the potential for reduction in cost of medical care.
Results of the RightMed Test and the MyLegacy genetic risk assessment will be reviewed with the individual by a Family Care Path genetic counselor through CarePathConnect, a video-based telegenetic service. Associated recommendations and reports will be provided to the person to share with their physician for treatment plan development.
"We are excited by the opportunity to add value to Family Care Path's My Legacy solution," said Patrick McIntyre, OneOme's CEO. "We believe this collaboration will showcase the benefits of pharmacogenomics – both for medication management and as part of a broader genomic wellness program."
Family Care Path, Inc. was formed in 2016 as a spin-off company from Cleveland Clinic Innovations with the objective to bring patient-benefiting products from the academic institute to market. Family Care Path develops, adapts and markets web-based clinical software applications designed to improve patient outcomes and increase physician and clinical process efficiency. Using the latest technology, Family Care Path develops secure, scalable applications that leverage industry-standard technologies such as Microsoft Cloud and both the SMART® and HL7® FHIR® open standards, to create applications that can seamlessly communicate with electronic health record systems.
OneOme, LLC, co-founded by Mayo Clinic, is a leader in providing evidence-based pharmacogenetic solutions that support personalized prescriptions around the world. Combined with an in-house CLIA-certified, CAP-accredited lab, OneOme's RightMed Test provides comprehensive genetic insights that physicians, pharmacists and other healthcare professionals can use to make more informed medication decisions for their patients. OneOme is based in Minneapolis, MN, USA. For more information, visit www.oneome.com.
Editor’s Note: Mayo Clinic has financial investment in the technology referenced in this news release. The revenue that Mayo Clinic is using support its not-for-profit mission in patient care, education and research.
MINNEAPOLIS and 'S-HERTOGENBOSCH, Netherlands, Nov. 19, 2019 /PRNewswire/ -- OneOme today announced a pilot partnership with Alliance Healthcare Netherlands (a wholly owned subsidiary of Walgreens Boots Alliance) that will bring pharmacogenomic testing to selected Boots and Alphega Pharmacy locations throughout the Netherlands.
Pharmacogenomics (PGx) is the study of how DNA may affect individual response to medications. PGx testing analyzes a patient's DNA to give doctors and pharmacists information that may help them optimize medication selection for that patient, reduce trial and error in the prescribing process, potential healthcare costs and decrease the likelihood of adverse drug reactions.
"The OneOme team is thrilled to be partnering with Alliance Healthcare Netherlands. This is an organization that is committed to delivering exceptional patient care. We are excited to work with the pharmacists at pilot locations to provide medication optimization through pharmacogenomic insights," said Morgan Donaldson, Director of International Business Development for OneOme.
As part of the initial pilot, pharmacists at 18 Boots and Alphega Pharmacy locations in the Netherlands will be able to order OneOme's RightMed® comprehensive test* for their patients. Patients will be able to give their DNA sample in the pharmacy with a cheek swab. When the pharmacists get the patient's results, they will schedule a consultation with the patient, as well as reach out to the patient's general practitioner to discuss the results and how they may be relevant to the patient's medications.
The pilot phase of the partnership is intended to evaluate the feasibility of offering PGx testing in all Boots and Alphega retail pharmacy locations in the Netherlands, as well as to understand the impact on patient care. Manuel Voll, Director Alphega Pharmacies in the Netherlands, noted, "We look forward to working with OneOme to ensure a successful implementation and to capture important insights about how patients and pharmacies can benefit from the RightMed test."
OneOme's RightMed comprehensive test and report provide insights on 27 genes for 300 different medications, giving pharmacists and doctors valuable genetic information they can use to help optimize medication selection for their patients.
Alliance Healthcare Netherlands is a versatile company in the entire pharmaceutical care chain from producer to consumer. This unique position enables Alliance Healthcare to integrate the various needs of stakeholders within the chain and thus arrive at innovative solutions. The health and well-being of customers is the companies connecting factor. By forming strategic partnerships, Alliance Healthcare guarantees the quality of the care and the optimal support of the customer. Cooperation is the companies key to success.
Internationally leading brand Alliance Healthcare Nederland is part of the Walgreens Boots Alliance. Walgreens Boots Alliance is present in more than 25** countries, employs more than 440,000 people and has more than 18,750 stores. The wholesale division supplies more than 115,000** pharmacies, doctors, health centers and hospitals from 300 distribution centers in 11 countries. Alliance Healthcare is the market leader in Europe.
Alphega Pharmacy is a chain of 132 independent pharmacists in the Netherlands, with a strong focus on healthcare. Alphega Pharmacy is a leading European network of independent pharmacists, with the aim of improving the health and well-being of communities, by providing innovative services for independent community pharmacies. Alphega is present in 10 European countries and comprises approximately 6,800 pharmacies (as of 31 August, 2019). Alphega's pharmacy formula is part of Alliance Healthcare Nederland B.V.
Boots Pharmacy is a fully owned pharmacy chain with 59 pharmacies in the Netherlands. Boots operates local and large pharmacies in Schiphol Airport Amsterdam and Utrecht Central Station. Boots is active in fourteen countries around the world and has more than 4,600 pharmacies (as of 31 August 2019). Boots Nederland is part of the International Retail Pharmacy Division of Walgreens Boots Alliance, the first global pharmaceutically managed health and welfare company.
OneOme, LLC is a leader in providing evidence-based pharmacogenetic solutions that support personalized prescriptions around the world. Combined with an in-house CLIA-certified, CAP-accredited lab, OneOme's RightMed test provides comprehensive genetic insights that physicians, pharmacists and other healthcare professionals can use to help make medication decisions for their patients. OneOme is based in Minneapolis, MN, USA. For more information, visit www.oneome.com.
* OneOme's RightMed comprehensive test is not available in the U.S.
** 12 months for the year ending 31 August 2019, excluding investments according to the Equity method.
Patrick joined OneOme as Chief Executive Officer in July 2019. Patrick has more than 25 years of healthcare experience, the vast majority of which has been in leadership roles over advanced analytics, healthcare economics, clinical informatics, and medical finance in national and regional payer organizations. He has built and led industry-leading analytics capabilities at UnitedHealthcare/Optum, Anthem, and Aetna. Patrick received his MBA from Winthrop University and his BBA from Texas Tech University. He is a former Certified Public Accountant in South Carolina, and he served for 5 years on active duty in the United States Marine Corps.
Bronwyn leads laboratory operations at OneOme, including managing quality assurance and driving continuous improvement. She has 20 years of experience in molecular genetics, with expertise in the design and validation of laboratory-developed procedures, high-complexity clinical laboratory operations, quality systems, regulatory compliance, and medical device software. Bronwyn is a contributing member of CPIC and PharmVar, and serves on the steering committee of the STRIPE Collaborative Community. She earned her B.S. in Biology at Trinity University and her Ph.D. at Indiana University, followed by a postdoctoral fellowship in microbial pathology at the University of Iowa.
Colin joined OneOme as a Senior Finance Director in December 2019. He is a Certified Healthcare Financial Professional (CHFP), experienced in financial reporting, budgeting, modeling, and accounting. His technical finance and accounting experience is paralleled by industry knowledge, system expertise, and collaboration skills. Previously, he held roles leading financial analytics for the University of Minnesota Physicians and managing finance and accounting at Gravie, a venture-backed health insurance brokerage. Colin received his BA from Hamline University and is currently completing his MBA at Saint Mary’s University of Minnesota.
Dr. Julie England joined OneOme in September 2018. She is a board-certified physician with over 15 years of clinical experience in Family Medicine, which gave her experience with a variety of medical issues. While performing in this setting she became interested in precision medicine, which led to her opening a small concierge practice and joining OneOme in 2018 as a medical advisor. Dr. England now leads OneOme's Medical Affairs department and enjoys working with providers and policy makers on PGx education and implementation. Julie received her B.A. in Biology from the University of Michigan and her M.D. from the American University of the Caribbean College of Medicine. She completed her residency training in Family Medicine at the University of Minnesota.
Kurt joined OneOme in November 2016. With over 20 years of experience developing software and leading technology teams, he has worked on architecting and running a wide variety of software systems primarily in the healthcare space. His technology knowledge is paired with his experience collaborating closely with subject matter experts to build quality technology solutions. Previously he led the software development team at a large medical speciality society. Kurt received his B.A. in Chemistry with a concentration in Computer Science from St. Olaf College.
Prior to joining OneOme, Tanya worked at Anthem, Inc. for almost six years in executive roles focused on strategy, planning, and process improvement. Previously, she was employed by UnitedHealth Group for 11 years, where she worked within the areas of program and project management and served as chief of staff for Quality Management and Performance. In 2016, she was honored as one of the 51 Women in Business award winners by the Minneapolis/St. Paul Business Journal. Tanya holds a B.S. in Dietetics and a minor in Psychology from the University of North Dakota and a M.B.A. degree from Webster University.
John L. Black III, M.D. is one of the co-founders of OneOme and also a consultant in the Division of Clinical Biochemistry and Immunology with a joint appointment in the Department of Psychiatry and Psychology at Mayo Clinic in Rochester. He joined the staff of Mayo Clinic in 1985 and is currently the co-director of the Personalized Genomics Laboratory. He received his B.A. and M.S. in psychology from the University of Wyoming. He received his M.D. (cum laude) from Creighton University School of Medicine. He is board certified in general, geriatric, and addiction psychiatry and is a clinical chemist.
Dr. Wang is a professor in the Department of Molecular Pharmacology and Experimental Therapeutics (MPET) at Mayo Clinic Rochester. Her research involves the application of high-throughput "omics" technologies to identify biomarkers that might help us individualize cancer therapies, understand mechanisms of drug action, and facilitate target identification and drug development. She is also a co-leader of the Mayo Pharmacogenomics Program within the Mayo CIM, where many of the projects involving personalized medicine have been conducted. She is the co-PI for the Mayo-NIH clinical pharmacology T32 training grant and the Associate Director for the Mayo MPET graduate program.
Dr. Weinshilboum received B.A. and M.D. degrees from the University of Kansas, followed by residency training in internal medicine at the Massachusetts General Hospital. He was also a pharmacology Research Associate at the National Institutes of Health (NIH). He began his affiliation with the Mayo Medical School and Mayo Clinic in 1972, where he is presently Professor of Pharmacology and Medicine and Mary Lou and John H. Dasburg Professor of Cancer Genomics Research. He currently directs the Pharmacogenomics Program of the Mayo Center for Individualized Medicine and is co-Principal Investigator of the long-standing US NIH Pharmacogenomics Research Network Center at the Mayo Clinic.
OneOme was named one of the World's 50 Most Innovative Companies for 2018 by Fast Company:
#22 overall and #2 in biotech.