About the PGx Test, Warnings & Limitations
About this PGx report
Our Pharmacogenomic (PGx) Report provides information about how a patient's genetic makeup affects their response to medication. Genetic variants may speed or slow down the metabolism of certain drugs and may also make a patient more or less prone to side effects associated with the use of certain drugs.
This report provides information about 50+ drugs, based on the guidelines developed by specialized organizations such as the Clinical Pharmacogenetics Implementation Consortium (CPIC), US Food and Drug Administration (FDA), Pharmacogenomics Knowledge Base (PharmGKB), and the Dutch Pharmacogenetics Working Group (DPWG).
The information in this report is provided for:
- a specific genetic variant, denoted by its rsID
- a metabolizer type, based on a set of variants found in a certain gene. Each patient carries a combination of two alleles, denoted by a star (e.g. *1*2) which are mapped to a specific metabolizer type as defined by CPIC and PharmGKB
Evidence levels
Variant-drug or metabolizer-drug information carries the following evidence levels:
- ⭐⭐⭐ These are variant-drug combinations that include known pharmacogenes and have variant-specific prescribing guidance available in a current clinical guideline annotation or an FDA-approved drug label annotation with at least one publication in addition to the clinical guideline OR have high level of evidence supporting the association with at least two independent publications.
- ⭐⭐ These variant-drug combinations include known pharmacogenes and have a moderate level of evidence supporting the association, with at least two independent publications. For example, the association may be found in multiple cohorts, but there may be a minority of studies that do not support the majority assertion.
- ⭐ These are variant-drug combinations with a low level of evidence supporting the association. This association may be based on a single study or there may be several studies that failed to replicate the association. The annotation may also be based on preliminary evidence (e.g., a case report, non-significant study, or in vitro, molecular, or functional assay evidence). Alternatively, this is an association involving a rare genotype that has been extrapolated based on information available for more common and well studied genotypes.
Prescribing guidance
Recommendations about drug dosages and administration are obtained from CPIC, FDA, or DPWG guideline publications.
Based on the available information and recommendations, drugs are classified into two categories:
- Standard precautions: The patient may respond well to this drug, with a low risk of side effects. Often, the standard recommended dosage is advised for this drug.
- Use with Caution: The patient may be at an increased risk of adverse events and may need monitoring for efficacy or side effects. Standard dosage may not be adequate for certain drugs, and, in some cases, an alternative drug may be recommended.
Warnings and limitations
This report is intended to provide supplementary health information, for use by a physician, pharmacist or other healthcare professional to advise a patient on the use of prescribed medications.
Physicians should consider current prescriptions, symptoms, family history, and other factors before making any clinical decisions.
This report IS NOT a 510k cleared test and IS NOT managed by FDA. Results are dependent on adequate specimen collection, processing and the accuracy of the genotyping platform utilized to create this report. While unlikely, this report may provide false positive or false negative results. Confirm any results with an independent specialized genetic test before making any medical decisions.
The ordering physician is responsible for the diagnosis and management of disease and decisions based on the data provided.
Pharmacogenetic tests from other companies may include different genetic variants and may therefore provide slightly different results.
Can I see a sample report?
Of course! Email support@selfdecode.com to request a sample PGx report.
DISCLAIMER:
This PGx report does not provide medical advice. This report does not account for lifestyle or other health factors that may affect drug metabolism and does not look at all possible genetic variants that may affect the metabolism of a certain drug. This report does not diagnose any health conditions or diseases and does not inform about any risk of developing any health conditions or diseases.
Empower your clients with personalized prescription guidance with these instructions!