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On February 20, FDA released a Table of Pharmacogenetic Associations (updated February 25) and opened a docket for gathering feedback and comments.

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.*

Introduction

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").

General feedback

  • 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.

Specific feedback

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.

Recommendations

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.

References

  1. 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.
  2. 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.
  3. FDA. Dilantin (phenytoin sodium) package insert: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/084349s060lbl.pdf Accessed 2/27/2020.
  4. FDA. Celexa (citalopram) package insert: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020822s038s040,021046s016s017lbl.pdf Accessed 2/27/2020.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.

About OneOme

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.

About Boots

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.

About OneOme

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.

McIntyre Brings 30+ Years Of Experience As A Healthcare Executive, Including COO And CFO Positions

MINNEAPOLIS – July 8, 2019 – OneOme has named Patrick McIntyre, a healthcare executive with more than three decades of experience in management, operations, and finance, as its Chief Executive Officer. McIntyre replaces Paul Owen, who joined to lead the company in 2015 and who will oversee the transition.

McIntyre’s more than 30 years in healthcare management includes work with data-driven startups and Fortune 50 companies. He has experience leading analytics, business operations, and financial functions.

McIntyre’s most recent role was as the President and Founder of Portage Health Insights, a healthcare consulting practice. Prior to founding Portage Health Insights, McIntyre was a Senior Vice President at Anthem, Inc., overseeing enterprise-wide healthcare analytics functions including medical cost management programs governance, medical economics, provider analytics, fraud, waste and abuse analytics, and data science functions. He also spent eight years at UnitedHealth Group, serving most recently as Vice President of Healthcare Analytics.

“As patients demand more personalized care from their healthcare providers, pharmacogenomics will become increasingly more central to patient care,” McIntyre said. “Understanding the correlation between genetics and medications has the potential to reduce adverse drug events, and as a result reduce overall medical costs and improve clinical outcomes, while offering an improved patient experience. I’m thrilled to be in a position to help OneOme achieve this vision.”

“Like other industries, healthcare and diagnostics are going through a significant transformation. OneOme is positioned to be a major player in how pharmacogenomics is defined in the industry and used in patient care,” said Danny Cunagin, OneOme Board member and co-CEO of Invenshure. “Bringing Patrick on will enable OneOme to continue to grow our existing channels while expanding into adjacent markets with significant untapped potential.”

McIntyre is a graduate of Texas Tech University, where he earned a bachelor’s degree in business administration. He received a Master of Business Administration from Winthrop University. McIntyre served on active duty in the United States Marine Corps and then later served in the US Army Reserves.

“It has been an honor and a privilege to lead OneOme,” Owen said. “While we have enjoyed tremendous success as a team, I have no doubt that we are positioned for an even brighter future. Patrick is the ideal executive to move OneOme into its next chapter. His vast experience in healthcare analytics, business development, operations and finance which will help to power our company into the future.”

About OneOme

OneOme was co-founded with Mayo Clinic to bring pharmacogenomics into routine clinical care. OneOme is a privately held company backed by early-stage venture firm Invenshure, LLC and Mayo Clinic.

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.

June 20, 2019 - Minneapolis, MN - OneOme, a leading provider of pharmacogenomics solutions, today announced it won a MedTech Breakthrough Award in the category of Best Overall Genomics Company.

The MedTech Breakthrough Awards recognize innovative leaders in healthcare technology and encompass a broad range of categories. This year, thousands of nominations from around the world were evaluated by an independent panel of experts from the MedTech industry.

“Being named Best Overall Genomics Company by the MedTech Breakthrough Awards is a huge honor,” said OneOme CEO Paul Owen. “Our team is committed to providing the highest quality, evidence-based pharmacogenomics testing and technology. This recognition demonstrates the value we bring to the healthcare industry and validates our philosophy of putting scientific rigor and clinical utility at the heart of everything we do.”

For a full list of 2019 winners, visit https://medtechbreakthrough.com/2019-winners/.

About OneOme

OneOme was co-founded with Mayo Clinic to bring pharmacogenomics into routine clinical care. OneOme is a privately held company backed by early-stage venture firm Invenshure, LLC, and Mayo Clinic.

Editor’s Note: Mayo Clinic has financial investment in the technology referenced in this news release. The revenue that Mayo Clinic will receive is used to support its not-for-profit mission in patient care, education and research.