About the PGx Report: Warnings & Limitations
This article covers the clinical details, evidence standards, and important limitations of the Medication Check (Pharmacogenomics/PGx) Report. For a general overview of what the report covers and how to use it with clients, see our Medication Check (PGx) Report FAQ.
What the Report Provides
The PGx Report shows how your client's genetic makeup affects their response to 50+ medications. Genetic variants can speed up or slow down drug metabolism and may make a client more or less prone to side effects.
The report provides information based on two types of genetic data:
- Specific genetic variants — identified by their rsID
- Metabolizer types — determined by a combination of variants (alleles) found in a gene. Each client carries two alleles (e.g., *1/*2), which are mapped to a metabolizer type as defined by CPIC and PharmGKB
Prescribing Guidance
Based on available clinical guidelines, each medication in the report is classified into one of two categories:
Standard Precautions — The client is likely to respond well to this drug at standard dosages, with a low risk of side effects.
Use With Caution — The client may be at increased risk of adverse events. Standard dosage may not be adequate, monitoring for efficacy or side effects may be needed, and in some cases, an alternative drug may be recommended.
All prescribing guidance is sourced from published guidelines by CPIC, FDA, and/or DPWG.
Evidence Levels
Each variant-drug or metabolizer-drug association in the report carries an evidence rating:
⭐⭐⭐ High Evidence Known pharmacogene with variant-specific prescribing guidance in a current clinical guideline or FDA-approved drug label, supported by at least one additional publication. Alternatively, a high level of evidence with at least two independent publications.
⭐⭐ Moderate Evidence Known pharmacogene with a moderate level of evidence, supported by at least two independent publications. The association is found in multiple cohorts, though a minority of studies may not support the majority finding.
⭐ Low Evidence Association based on a single study, non-significant findings, preliminary evidence (e.g., case report, in vitro or functional assay), or a rare genotype extrapolated from more common and well-studied genotypes.
Clinical Guidelines Sources
The report is informed by guidelines from the following organizations:
- CPIC — Clinical Pharmacogenetics Implementation Consortium
- FDA — U.S. Food and Drug Administration
- PharmGKB — Pharmacogenomics Knowledge Base
- DPWG — Dutch Pharmacogenetics Working Group
Warnings & Limitations
This report is intended to provide supplementary health information for use by a physician, pharmacist, or other healthcare professional to advise a client on prescribed medications.
Important considerations:
- This report does not provide medical advice. The ordering physician is responsible for diagnosis, disease management, and all clinical decisions based on the data provided.
- This report is NOT a 510(k)-cleared test and is NOT managed by the FDA.
- Consider the full clinical picture. Physicians should factor in current prescriptions, symptoms, family history, lifestyle, and other health factors before making clinical decisions.
- False results are possible. While unlikely, the report may produce false positive or false negative results. Results depend on adequate specimen collection, processing, and the accuracy of the genotyping platform. Confirm any clinically significant findings with an independent, specialized genetic test before making medical decisions.
- Not all variants are covered. The report does not account for all possible genetic variants that may affect drug metabolism, and does not detect gene deletions or duplications.
- Results may differ from other PGx tests. Pharmacogenetic tests from other companies may include different genetic variants and may therefore provide slightly different results.
- Lifestyle factors are not accounted for. The report does not consider age, weight, existing medical conditions, or other non-genetic factors that affect drug metabolism.
- This report does not diagnose any health conditions or inform about any risk of developing health conditions or diseases.
🙋 Need Help?
If you have questions about the PGx Report or need help sharing results with a client, reach out to us at support@promicsedge.com or use the chat bubble in your account.