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Frequently Asked Questions

Pharmacogenomics

Answer:

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.

Answer:

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.

Answer:

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.

Answer:

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.

 

ABCB1 ACE ADRA2A AGTR1 ANKK1
APOE ATM CDA CES1 CNR1
COMT CYP1A2 CYP2B6 CYP2C19 CYP2C8
CYP2C9 CYP2D6 CYP3A4 CYP3A5 CYP4F2
DPYD DRD1 DRD2 ERCC1 F2
F5 FAAH G6PD GRIK4 GSTP1
HLA-B HTR1A HTR2A HTR2C IFNL3
ITPA KIF6 MTHFR NAT2 NOS1AP
NQO1 OPRM1 SCN2A SLC6A4 SLCO1B1
TPMT UGT1A1 UGT2B15 VKORC1 XRCC1

Learn more about PGxOneTM Plus

Answer:

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.

PharmGKBis 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.

Answer:

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.

Answer:

PGxOne™ Plus test results will typically be available within 10 - 14 working days following receipt of the sample at our lab.

Answer:

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.

Answer:

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.

Answer:

To confirm coverage, please check with your insurance provider.

Answer:

Please check with your physician.