Who we are
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.
The latest news from OneOme
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").
- OneOme requests FDA publish the level of evidence criteria that was required for inclusion in each of Tables 1, 2 and 3, including requirements around demographics and in vitro and in vivo data, as well as how FDA assessed and reconciled limitations of the studies reviewed. Clarifying how FDA defines "sufficient scientific evidence" will help healthcare practitioners evaluate lab-developed PGx tests and laboratories assure their gene-drug associations meet FDA's standards.
- OneOme recognizes the challenges large organizations and regulatory agencies have in maintaining updates to their publications every time new, impactful research is published. However, citations are important to help providers understand what information was considered by FDA and therefore reconcile any differences between new or other existing data that may be applicable to patient care and the practice of medicine.
- OneOme has concerns that the lack of transparency around criteria for inclusion and absence of specific guidance from FDA related to PGx abrogates the clinical utility of this table. Moreover, it is likely that this will be misinterpreted by patients and providers as FDA's official guidance on PGx testing.
Critical omissions: Phenytoin and HLA-B*15:02 and CYP2C9
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.
Confusing category assignments
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:
- Collaborate with PGx experts in academia, industry, pharmacy, and clinical practice to achieve consensus on criteria and level of evidence for documented PGx associations.
- Develop and share information on the timelines for reviewing new evidence and schedule for updating the Table.
- Publish draft guidance for PGx testing to clarify how this table fits into FDA’s future plans regarding PGx.
- CPIC®. Guideline for Phenytoin and CYP2C9 and HLA-B. https://cpicpgx.org/guidelines/guideline-for-phenytoin-and-cyp2c9-and-hla-b/ Accessed 2/27/2020.
- Dutch Pharmacogenomic Working Group. Dutch guidelines, November 2018 update. https://api.pharmgkb.org/v1/download/file/attachment/DPWG_November_2018.pdf Accessed 2/27/2020.
- FDA. Dilantin (phenytoin sodium) package insert: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/084349s060lbl.pdf Accessed 2/27/2020.
- FDA. Celexa (citalopram) package insert: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020822s038s040,021046s016s017lbl.pdf Accessed 2/27/2020.
- von Moltke, Lisa L., et al. "Citalopram and desmethylcitalopram in vitro: human cytochromes mediating transformation, and cytochrome inhibitory effects." Biological psychiatry 46.6 (1999): 839-849.
- Olesen, Ole V., and Kristian Linnet. "Studies on the stereoselective metabolism of citalopram by human liver microsomes and cDNA-expressed cytochrome P450 enzymes." Pharmacology 59.6 (1999): 298-309.
- CPIC®. Guideline for Selective Serotonin Reuptake Inhibitors and CYP2D6 and CYP2C19. https://cpicpgx.org/guidelines/guideline-for-selective-serotonin-reuptake-inhibitors-and-cyp2d6-and-cyp2c19/ Accessed 2/27/2020.
- Rudberg, I., et al. "Impact of the ultrarapid CYP2C19* 17 allele on serum concentration of escitalopram in psychiatric patients." Clinical Pharmacology & Therapeutics 83.2 (2008): 322-327.
- Mrazek, David A., et al. "CYP2C19 variation and citalopram response." Pharmacogenetics and genomics 21.1 (2011): 1.
*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."
About Family Care Path
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.
About Alliance Healthcare
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.
About Alphega Pharmacy
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.
People of OneOme
Patrick McIntyre - Chief Executive Officer
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.
Bernard Esquivel, MD, PhD — Chief Medical Officer
As OneOme’s International Chief Medical Officer and Medical Director of Clinical Science, Dr. Esquivel serves as subject matter expert and clinical and scientific resource in pharmacogenomic testing - ensuring awareness and understanding as well as expediting account adoption and international growth. He oversees OneOme's clinical development and laboratory teams, clinical trials, and scientific communication, and he also leads OneOme's global regulatory efforts. Dr. Esquivel is a practicing physician-scientist, senior executive, and international business leader focused on developing the genomics and precision medicine space over the past ten years. He is a clinical immunologist by training (UNAM) and received a postgraduate degree in Medical Genetics as well as a Ph.D. in Immunogenetics (Valencia). His passion for advancing the global clinical implementation of precision medicine is evident through his involvement with multiple genomics and pharmacogenomics organizations around the world, including having founded the Latin American Association of Personalized Medicine.
Steve Quinn — VP, Business Development for International Markets
As OneOme’s VP, Business Development for International Markets, Steve provides overall leadership and strategic direction for new business development in the international markets while maintaining and growing existing international client relationships. Steve has extensive experience in introducing new technologies to international markets through collaborations and team building with key opinion leaders. His commercial experience spans both medical devices and molecular genetics and includes 20 years of experience working for a leading diagnostics company where he held a number of senior leadership positions around the globe. He is also a former medical technologist, with several years’ experience working for the United Kingdom National Health Service. Steve holds multiple qualifications in medical sciences, business and finance, and he has also completed numerous courses in executive development.
Tanya Rylee — Chief Administrative Officer
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.
Colin Schulte — Senior Director of Finance
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.
Kurt Wiersma — Director of Technology
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.
Mayo Clinic Co-founders
John L. Black III, M.D. — Mayo Clinic, Co-Founder OneOme
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.
Liewei Wang, M.D., Ph.D. — Mayo Clinic, Co-founder OneOme
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.
Richard Weinshilboum, M.D. — Mayo Clinic, Co-founder OneOme
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.