About the PGx Report: Warnings & Limitations

This article covers the clinical details, evidence standards, and limitations of the Medication Check (Pharmacogenomics/PGx) Report. The report is supplementary information for a healthcare professional and is not a diagnostic or FDA-cleared test. For a general overview of the report and how to use it with clients, see the Medication Check (PGx) Report FAQ.

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What the Report Provides

The Medication Check (PGx) Report shows how your client's genetics affect 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 is 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 (for example, *1/*2), which are mapped to a metabolizer type as defined by CPIC and PharmGKB

Prescribing Guidance

Based on available clinical guidelines, each medication is classified into one of two categories:

• Standard Precautions — The client is likely to respond well to the 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 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 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. 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 (for example, a case report or in vitro assay), or a rare genotype extrapolated from more common, well-studied genotypes.

Clinical Guidelines Sources

• 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 provides supplementary health information for use by a physician, pharmacist, or other healthcare professional to advise a client on prescribed medications.

• This report does not provide medical advice. The ordering physician is responsible for diagnosis, disease management, and all clinical decisions.
• This report is NOT a 510(k)-cleared test and is NOT managed by the FDA.
• Consider the full clinical picture. Factor in current prescriptions, symptoms, family history, lifestyle, and other health factors before making clinical decisions.
• False results are possible. Though unlikely, the report may produce false positive or false negative results. 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 affecting drug metabolism and does not detect gene deletions or duplications.
• Results may differ from other PGx tests. Tests from other companies may include different variants and 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.
• This report does not diagnose any health conditions or indicate risk of developing health conditions or diseases.

🙋 Need Help?

If you have questions about the Medication Check (PGx) Report or need help sharing results with a client, email support@promicsedge.com or use the chat bubble in your account.