Comprehensive Pharmacogenomic Testing
- GTR Test IDHelpEach Test is a specific, orderable test from a particular laboratory, and is assigned a unique GTR accession number. The format is GTR00000001.1, with a leading prefix 'GTR' followed by 8 digits, a period, then 1 or more digits representing the version. When a laboratory updates a registered test, a new version number is assigned.: GTR000607865.2
- Last updated: 2023-05-11
- Test version history
Clinical testHelpIn the U.S., clinical tests must be performed under CLIA certification. When a lab uses the same methods for a test in both clinical and research settings, the test appears as two separate GTR records. for Drug metabolism or response
Offered by Innovative Genomics
Overview
Test name
HelpThe name the laboratory assigns the test. Used as the default title of the page specific to the test.Comprehensive Pharmacogenomic Testing (PGX)
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
Click Indication tab for more information.
Health care providers are able to order Pharmacogenetic testing electronically and by paper requisition. The ordering documents must be signed by the providers including current mediations AND medications of consideration. Lastly, a patient consent form must be signed by the patient.
Order URL HelpLink to the laboratory webpage with information about how to order this test. Please note that clicking on this link will open a new tab in your internet browser.: https://innovativegx.com/pharmacogenetics-pgx/
Specimen source
Methodology
HelpThe assay's major method category (biochemical, cytogenetic or molecular genetics); method category (i.e. enzyme assay, chromosome breakage studies, targeted mutation analysis); methodology (i.e. the name of the method used) and instruments used when performing this test.- Molecular Genetics
- TTargeted variant analysis
- NGS Amplicon sequencingSNP Detection
- Other
Guidance for selecting a drug therapy and/or dose
Clinical validity
HelpHow consistently and accurately the test detects or predicts the intermediate or final outcomes of interest. Lab-provided.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
Testing strategy
HelpThe lab's suggested sequence of ordering tests based on clinical scenarios. It may include information on: reflex testing including each test component, and scenarios which prompt additional components of testing; whether lab communicates interim results or automatically proceeds to further analyses; and if any components are performed in another laboratory.Your healthcare provider will have to order a PGx test for the patient if appropriate. Once received the collection kit, the healthcare provider will collect your DNA sample via buccal (cheek) swab, extracted gDNA sources, or whole blood samples before sending to IGX laboratory. The lab will perform DNA extraction and NGS library prep for amplicon sequencing. The data will be analyzed and the report will be generated in-house using IGX database. The report will then be provided to the healthcare provider and they will review the test results during a post-PGx consultation and develop a personalized treatment strategy. 000 Health care providers are able to order Pharmacogenetic testing electronically and by paper requisition. The ordering documents must be signed by the providers including current mediations AND medications of consideration. Lastly, a patient consent form must be signed by the patient.
Test services
HelpLaboratory's order or catalog code for the test (used in the order requisition form).- Clinical Testing/Confirmation of Mutations Identified Previously
IMPORTANT NOTE: NIH does not independently verify information submitted to the GTR; it relies on submitters to provide information that is accurate and not misleading. NIH makes no endorsements of tests or laboratories listed in the GTR. GTR is not a substitute for medical advice. Patients and consumers with specific questions about a genetic test should contact a health care provider or a genetics professional.