Leaders in pharmacogenomics

Clinical development of the RightMed® comprehensive test

At OneOme, our clinical development process is rigorous and backed by scientific and clinical data. We are driven to help healthcare providers optimize medication therapy by providing a credible, robust, and comprehensive pharmacogenomic solution.

Credible, evidence-backed pharmacogenomics

OneOme, co-founded by Mayo Clinic, developed the RightMed comprehensive test to bring pharmacogenomics into routine clinical care.

As a way to support the adoption of pharmacogenomic testing, Mayo Clinic conducted a study that provided evidence in favor of preemptive pharmacogenomic testing.

The study, “Preemptive pharmacogenomic testing for precision medicine,” evaluated the impact of preemptive pharmacogenomic (PGx) testing of five genes in 1013 subjects within a clinical setting.

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ACTIONABLE PGx VARIANTS ENTERED INTO EACH PATIENT’S EMR

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WHEN PROVIDER ORDERED MEDICATION, ALERT WAS TRIGGERED BASED ON CDS RULES

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99% OF THE PATIENTS CARRIED AN ACTIONABLE PGx VARIANT(S) IN AT LEAST ONE GENE

First, actionable PGx variants were entered into each patient’s electronic medical record. Next, when a provider ordered a medication relevant to the patient’s pharmacogenomic results, an alert was triggered based on clinical decision support rules. When considering all five genes together, 99% of the patients carried an actionable PGx variant(s) in at least one gene. This means that in nearly each subject, a genetic variation was found that impacts how the patient metabolizes a medication, and this variation should be reviewed prior to making a prescription decision.

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OneOme's rigorous standards for data curation and clinical guidelines

The RightMed comprehensive test provides the translation of scientific and clinical information into an intuitive, actionable format for use by healthcare providers.

At OneOme, data curation and clinical annotations are performed by a team of clinical pharmacists and scientists. The relationships between the medications and pharmacogenes annotated in our database are supported by scientific evidence that meets OneOme’s rigorous criteria for inclusion. Genotype-derived classification of medications is provided as a service by OneOme and is intended solely for use by a medical professional.

Provider considerations are curated by the OneOme clinical development team using sources such as US FOOD AND DRUG ADMINISTRATION (FDA) label excerpts or professional guidelines sourced from CLINICAL PHARMACOGENETICS IMPLEMENTATION CONSORTIUM (CPIC), DUTCH PHARMACOGENOMICS WORKING GROUP (DPWG), FRENCH NATIONAL PHARMACOGENETICS NETWORK (RNPGX) / GROUP OF CLINICAL ONCO-PHARMACOLOGY (GPCO-UNICANCER), or CANADIAN PHARMACOGENOMICS NETWORK FOR DRUG SAFETY (CPNDS).

Download our data curation white paper to learn more about our interpretation and reporting methodology.

RightMed pharmacogenomic database

The genes tested in the OneOme RightMed comprehensive test might affect other medications that are not included on the test or in our database. Currently the OneOme pharmacogenomic database includes information for approximately 1,000 of the most commonly used medications. OneOme provides a genotype-predicted interaction for over 230 of these medications based on the patient’s DNA profile. Drugs are classified according to the severity of the drug-gene interaction into one of the following categories on the RightMed comprehensive test report: red (major interaction), yellow (moderate interaction) and green (minimal interaction).

The absence of a medication in the OneOme report does not imply that there is no interaction between the medication and the genes analyzed in this test. Rather, it means that either the medication has not met OneOme's rigorous standards for inclusion on the test, or, more rarely, that the associated gene(s) involved in the metabolism of the medication are not part of the RightMed test. For many of these medications, OneOme has performed independent curation, and additional information (e.g., drug-to-drug interactions, case study summaries, etc.) for these medications is made available to providers through the RightMed Advisor.

Clinical limitations of the OneOme RightMed test

The OneOme RightMed comprehensive test must be ordered by a healthcare provider. OneOme reports, including the RightMed comprehensive test report, RightMed Advisor custom reports, and RightMed specialty reports, contain interpretations and clinical annotations that are intended solely for educational use by a medical professional and do not constitute medical advice by OneOme. The treating provider remains ultimately responsible for all treatment decisions, including decisions made on the basis of a patient's genotype.

Information included in the report is based upon scientific literature and does not take into account other genes and other environmental or social factors that may affect a patient's response. Other factors not included in this report include, but are not limited to, environmental factors (i.e., smoking), health factors (i.e., diet), social and familial factors, various medical conditions, and drug-to-drug interactions. Administration of any medication, including the ones listed in the OneOme reports, requires careful therapeutic monitoring regardless of the genotype-derived recommendation.

As a matter of practice, OneOme will routinely update its pharmacogenomic database as new information becomes available to the scientific community. As a result of these updates, medication classification and annotations found on the patient’s reports are dependent on the date the report was generated and/or the database version used to generate that report. Providers may review regenerated reports to view updated annotations generated using the latest released version, which is accessible through the provider portal at portal.oneome.com.

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