Physician FAQ

Physician FAQs

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.

ABCB1ACEADRA2AAGTR1ANKK1
APOEATMCDACES1CNR1
COMTCYP1A2CYP2B6CYP2C19CYP2C8
CYP2C9CYP2D6CYP3A4CYP3A5CYP4F2
DPYDDRD1DRD2ERCC1F2
F5FAAHG6PDGRIK4GSTP1
HLA-BHTR1AHTR2AHTR2CIFNL3
ITPAKIF6MTHFRNAT2NOS1AP
NQO1OPRM1SCN2ASLC6A4SLCO1B1
TPMTUGT1A1UGT2B15VKORC1XRCC1

Learn more about PGxOneTM Plus

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.

Genetic testing can aid in risk assessment, differential diagnosis and inform treatment decisions for patients with cardiovascular diseases and conditions.

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.
Genetic testing is easy and convenient. Upon request, Admera Health can provide a physician with a test supplies consisting of the test requisition form and sample collection materials. The patient sample (buccal swab, saliva or blood) can then be collected according to the instructions provided. Samples can then be mailed back to Admera Health in a convenient, pre-paid return packet.

To learn more, contact:
Admera Health Client Care
E: ClientCare@admerahealth.com
Phone: +1-908-222-0533

Specific submission requirements are as follows:
PGxOne™ Plus testing uses DNA isolated from buccal swabs or saliva.

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.

Saliva:
One saliva collection supply is provided to the physician. The tube must be filled with saliva to the black wavy line as detailed in the provided instructions. Following collection, tighten the cap and shake the tube for at least five seconds to ensure proper mixing of the saliva with the stabilizing solutions.

View PGxOneTM Plus specimen submission instructions

View PGxOneTM Plus sample submission guidelines video

View CardioGxOneTM specimen submission instructions

Saliva:
One saliva collection supply is provided to the physician. The tube must be filled with saliva to the black wavy line as detailed in the provided instructions. Following collection, tighten the cap and shake the tube for at least five seconds to ensure proper mixing of the saliva with the stabilizing solutions.

Blood:
A lavender top vacutainer tube containing ETDA is used to collect up to 5mls of blood. Following collection, invert the sample tube 8 to 10 times to ensure proper mixing. Please note blood samples should be shipped with the enclosed cold pack.

All samples can be sent to Admera Health using the pre-paid and pre-addressed packet provided.

View CardioGxOneTM specimen submission instructions

Admera Health has more specialized reports that present the information in a manner that is more tailored towards a specific therapeutic area.
PGxOne™ Plus is a comprehensive report with specific sections driven by ICD 10 codes and current medications.
PGxPsych™ is a specialty report highlighting psychiatric drugs with favorable recommendations in the first section of the report.
PGxOnco™ is a specialty report with specific sections for drugs commonly used in cancer supportive care and chemotherapeutics.
PGxCardio™ is a cardio branded report.
All reports are all-inclusive, have ICD-10 & current medication driven sections, and available in Spanish.
PGxOne™ Plus test results will typically be available within 7-10 business days following receipt of the sample at our lab.

CarioGxOne™ and AtheroGxOne™ test results will typically be available in 3-4 weeks following receipt to the patient samples.

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.

CardioGxOne™ and AtheroGxOne™:
The sequencing component will be done by Admera Health and the results are interpreted by our partner, Health in Code, utilizing their expertise and proprietary knowledgebase.

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 by your insurance provider, please call Admera Health Billing
Phone: +1-908-222-0533 press option 2
Please call +1-908-222-0533, option 2 for any billing questions
To order more test supplies, contact:

Admera Health Client Care
Email: ClientCare@admerahealth.com
Phone: +1-908-222-0533 press option 1

Alternatively, Admera Health has partnered with a logistics company that tracks supply volume via barcode scanning and will automatically replenish inventory once 70% of the supplies have been utilized.

Admera Health Client Care
Email: ClientCare@admerahealth.com
Phone: +1-908-222-0533 press option 1

General Inquiries
Email:Info@admerahealth.com