SmartMeds+ Pharmacogenomic Testing By Innovative GX Health

Indication

This is a clinical test intended for HelpPurposes or indications for the test. Lab-provided.: Diagnosis, Drug Response, Monitoring, Predictive, Risk Assessment, Screening, Therapeutic management

Patients with a family history of a serious adverse drug reaction(s) or known pharmacogenomic variant(s); Patients who have experienced multiple treatment failures; Patients who have had severe adverse drug reactions or complications due to medications; Identifying patients who require a higher or lower than standard dose of a medication.

With the goal to detect and predict if genetic variants are related to the presence, absence, or risk of diseases, IGX directly sources the drug-gene interaction pairs and actions to be taken for the PGx test from biomarker information found in the FDA’s Table of Pharmacogenetic Associations. This table illustrates patient subgroups with genetic variants, or genetic variant-inferred phenotypes that are likely to have altered drug metabolism, and in some instances, differential therapeutic effects, including differences in adverse events risks. Additionally, IGX directly sources drug-gene interactions from the FDA’s Table of Pharmacogenomic Biomarkers in Drug Labeling, which lists therapeutic products from the Drugs@FDA website with pharmacogenomic information in their drug labeling. From the Clinical Pharmacogenetics Implementation Consortium (CPIC), IGX only sources Level A and B gene-drug pairs and clinical practice guidelines for inclusion in the PGx test. The target population for the test are adults whose providers have identified on them therapeutic failure, personal or family history of adverse drug reactions, experiencing polypharmacy, the medications they intend to use have FDA black box labels, and/or provide pharmacogenomics guidance and recommendations in their labels, or the provider has identified that either the patient establishes an exaggerated response to a medication’s standard dose, or requires a higher dose to achieve the desired response.

Citations

Not provided

Guidance for selecting a drug therapy and/or dose