Pharmacogenomics is the study of genetic variations that influence an individual’s response to drugs. Pharmacogenomics is the combination of pharmacology and genomics. Pharmacology is the part of science that studies how drugs work. Genomics is the study of a person’s genome including the interactions of those genes with each other and with the person’s environment. Each person responds uniquely to treatment, while one treatment approach may work well for one individual, the same approach may not be effective or may cause adverse drug effects in other patients. The implementation of pharmacogenomics helps physicians make informed treatment decisions. This will lead to better outcomes by decreasing adverse drug events and by increasing the effectiveness of drugs.
Pharmacogenomics testing is recommended for any patient who is taking multiple medications, experienced pharmacotherapeutic failure, had a severe adverse drug reaction or complications due to ADEs, and taking medications with FDA’s require/recommend PGx testing.
FDA Website
Pharmacogenomics testing is also recommended for polypharmacy patients and any patient who is receiving drug treatment.
PGxOne™ Plus provides comprehensive coverage. It assays 53 genes in a single test covering over 310 medical condition and 20 therapeutic areas including cardiology, oncology, pain management, and psychiatry. It detects around 200 variants and provides recommendations for over 300 commercial drugs. PGxOne™ Plus utilizes the most advanced technology NGS, provides medically actionable and clinically relevant data. NGS delivers comprehensive genetic variant coverage and capable of detecting Copy Number Variations, deletions, insertions, and substitutions. It applies proprietary bioinformatics methodologies for data analysis and interpretation. The process is easy and convenient and has a fast turn-around-time.
PGxOne™ Plus has been validated to screen clinically relevant and medically actionable variations within 50 genes that govern the absorption, metabolism, and activity of many drugs. The genes and genetic variations tested by PGxOne™ Plus are acknowledged by multiple regulatory bodies, and have clinical implications for a wide range of therapeutic categories. Below is a table listing the genes assessed by PGxOne™ Plus.
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PGxOne™ results inform dosing recommendations for 220 commercial drugs. All 220 drugs are directly influenced by the 50 pharmacogenomic genes covered by PGxOne™ Plus, and carry pharmacogenomic recommendations put forth by the FDA, EMA, and/or CPIC.
PGxOneTM Plus Drugs by Speciality
View list of pharmacogenomic biomarkers (genes) in FDA-approved drug labeling, as well as the affected drugs/medications.
PharmGKB is a pharmacogenomics knowledge resource that encompasses clinical information including dosing guidelines and drug labels, potentially clinically actionable gene-drug associations and genotype-phenotype relationships.
View PharmGKB database of drugs with pharmacogenomics indications in their labeling.
Genetic testing can aid in the risk assessment, differential diagnosis, and guide treatment decisions for patients with cardiovascular diseases and conditions. Patients are good candidates for genetic testing if they have a close family relative who has had a cardiovascular condition. Familial testing is recommended for screening of first-degree family members of those who have been diagnosed with a disease-causing mutation or where a sudden cardiac death has occurred.
Patients need only to be tested once, as genetic information does not change over time. Therefore, genetic testing results have lifetime utility.
Specific submission requirements are as follows: PGxOne™ Plus testing uses DNA isolated from blood and buccal swabs. Blood is preferred.
Blood: Blood collection kits are provided to the physician. 4ml of whole blood EDTA. Buccal Swabs: Two buccal swabs are provided in the test supplies sent to the physician by Admera Health. Both swabs should be used to obtain buccal cells from the patient’s cheeks according to the instructions provided. The swabs should be placed into the collection tube as indicated.
PGxOne™ Plus test results will typically be available within 10 - 14 working days following receipt of the sample at our lab.
PGxOne™ Plus:
The sequencing data obtained during the test process will be analyzed by the Admera Health Bioinformatics group using proprietary algorithms. Admera Health interprets the results and present them to the physician in a clear, concise, and easy to understand report.
PGxOne™ Plus sequencing data (variant detection) has been validated by direct comparison to data generated by Sanger sequencing. PGxOne™ Plus displayed 100% sensitivity (true positive detection rate) and 100% specificity (true negative detection rate). PGxOne™ Plus accuracy was determined at >99.99% with 66296 of 66289 bases in the Sanger data set correctly called using PGxOne™ Plus data.
To confirm coverage, please check with your insurance provider.
Please check with your physician.