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 study 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 predicts how individuals will respond to medication. It is recommended for any patient who is receiving or will receive medications that have pharmacogenomics biomarkers indicated in their labeling.

FDA Website

Pharmacogenomics testing is also recommended for poly pharmacy patients and any patient who is receiving drug treatment.

PGxOne™ Plus is a comprehensive, pharmacogenomics test that assays 50 genes and detect ~200 variants and CNVs in a single, cost-effective test. Numerous therapeutic areas include (but not limited to) psychiatry, cardiology, pain, gastroenterology, neurology, rheumatology, oncology, hematology, women’s health, infectious disease, and endocrinology. Advanced next generation sequencing technology enables comprehensive coverage of variants in 50 genes. PGxOne™ Plus results are delivered quickly via an intuitive, clinically relevant, medically actionable report. Any patient that has been diagnosed with, or is currently being treated for a disease within any of these therapeutic categories will benefit from the test.
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

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 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
T: +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

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
T: +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
E: ClientCare@admerahealth.com
T: +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
E: ClientCare@admerahealth.com
T: +1-908-222-0533 press option 1

General Inquiries
E: Info@admerahealth.com