The PGxOne™ Plus Report: Genetics for Smarter Medication Management
By Admera Health on Oct 13, 2020 11:50:39 PM
Admera Health’s PGxOne™ Plus test pairs robust DNA analysis with clinically insightful gene-drug annotations to provide medically actionable results. Test results are delivered in an easy to read, color-coded report with gene-drug interactions aligning with the FDA’s latest recommendations. In combination with Admera Health’s online portal, RxVision™, the PGxOne™ Plus test provides the most complete PGx assessment available for patient management solutions.
The report includes iconographic results of drug responses based on gene-drug interactions
Consider Alternatives: refers to gene-drug pairs in which the interaction between a drug and one or several genes may result in a clinically severe and potentially deadly adverse drug reaction(s) and lack of efficacy. Most medications included in this gene-drug pair category still can be used. However, extreme caution and clinical judgment should be exercised. Providers should share the corresponding gene-drug interaction with their patients and follow FDA recommendations.
Use with Caution: refers to gene-drug pairs in which the interaction between a drug and one or several genes may result in a mild adverse drug reaction(s) and lack of efficacy. Most medications included in this gene-drug pair category still can be used. However, caution and clinical judgment should be exercised. Providers should share the corresponding gene-drug interaction with their patients and follow FDA recommendations.
Drug Management: refers to gene-drug pairs in which a negative drug response (adverse drug reaction(s) and lack of efficacy) might be preventable by adjusting the medication to the patient's individual needs based on pharmacogenomic results and any other non-genetic factors of your knowledge. Providers should exercise caution and clinical judgment, share the corresponding gene-drug interaction their patients, and follow FDA recommendations.
Normal Response Expected: refers to gene-drug pairs in which the corresponding drug response (adverse drug reaction(s) risk and efficacy) shall correlate with the FDA label description and is like that of the general population. Keep in mind that all drugs come with associated risks and should be taken into consideration when prescribing any medication. Providers should exercise caution and clinical judgment, share the corresponding gene-drug interaction their patients, and follow FDA recommendations.
Given its comprehensive nature, the report is divided into the following sections
The Quadrant-Cover Page
In addition to including the Patient Health Information (PHI), this page provides a snapshot of the Gene-Drug Interactions for the patient’s Current Medications and Medications of Interest (more on that below).
The medications are arranged in alphabetical order and will only be listed if there is a medically actionable patient impact applicable to the medication.
Section I: Current Medications and Medications of Interests
This section contains clinical interpretation for the patient’s current medications and medications of interest, a list of drugs a provider supplies when ordering the PGxOne™ Plus test.
By including Medications of Interest, providers will gain insight into drugs that that they are considering for their patient’s DNA may have an impact pre-emptively.Gene-drug annotations are organized and filtered alphabetically in the following order therapeutic area, drug class, mechanism of action, and drug name. The annotation provides the source, gene, patient specific genotype, and patient impact. The patient impact statement will also provide a clinically insightful explanation of the pharmacogenomic interaction and why that result is expected.
Current Medications and Medications of Interests with No or Limited Pharmacogenomics Evidence
Gene drug interactions aligning with the FDA’s latest recommendations will be reported. Drugs submitted by the ordering provider that do not meet this threshold can be found in a subsequent table. However, it is possible that additional relevant information for these drugs can be found in Admera’s dynamic online reporting tool, RxVision™.
Gene drug interactions aligning with the FDA’s latest recommendations will be reported. Drugs submitted by the ordering provider that do not meet this threshold can be found in a subsequent table. However, it is possible that additional relevant information for these drugs can be found in Admera’s dynamic online reporting tool, RxVision™.
To read more about how sources for pharmacogenomics evidence are curated and tiered, please check out this blog:
Applicable Drug Interactions
The PGxOne™ Plus report also provides the following drug interactions for the current medications found in Section I of the report.
Section II: Comprehensive Drug List
This section includes gene-drug interactions for a 60+ gene panel and approximately 100 medications aligned with the latest FDA pharmacogenetic recommendations, arranged by therapeutic area, drug class, and mechanism of action. It is designed to help optimize treatment options and manage patients with multiple conditions, effectively and efficiently.
The PGxOne™ Plus test includes biological relevant annotations.
Dual Recommendations: certain gene-drug annotations have dual iconographic recommendation, both a primary impact statement and secondary situational dependent statement.
Combinatorial Annotations: other drug interactions can involve multiple genes that affect the Patient Impact. In the body, there are some instances where a medication interacts with more than one protein for it to complete its purpose or for it to travel to the appropriate location. These different proteins can be coded by different genes. Since these proteins and genes work together in a biological system, it is important to evaluate them in combination. The PGxOne™ Plus test does this by providing a combined or dual impact statement.
Section III: Genotype and Phenotype Results
This section will have the patient specific gene, genotype, and phenotype information of all 60+ genes analyzed in the panel.
RxVision™
As a complement to the PGxOne™ Plus test, Admera Health has RxVision™, a dynamic online reporting tool that provides more comprehensive and in-depth pharmacogenomics-based management solutions. With this tool, providers gain digital access to all patients’ PGxOne™ Plus results. The platform is easy to navigate and uses dynamic searches by medication, therapeutic area, and drug interactions.
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