Admera Health PGxOne™ Plus
Clinical Genetic Test
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offered by
GTR Test Accession: Help GTR000567653.8
NYS CLEP
CAP
PHARMACOGENOMICINHERITED DISEASEINHERITED DISEASE SUSCEPTIBILITY ... View more
Last updated in GTR: 2023-06-21
Last annual review date for the lab: 2023-06-21 Past due LinkOut
At a Glance
Drug Response; Therapeutic management
Drug metabolism or response; Abacavir hypersensitivity; Allopurinol response more...
BCHE (3q26.1); CYP2B6 (19q13.2); CYP2C19 (10q23.33); CYP2C9 (10q23.33); CYP2D6 (22q13.2) more...
Molecular Genetics - Targeted variant analysis: CNV Detection; Next Generation Sequencing; Quantitative PCR (qPCR); ...
Patients taking or expecting to take medications included on the …
Pharmacogenomics testing to assess how a patient may respond to …
Guidance for selecting a drug therapy and/or dose
Ordering Information
Offered by: Help
Test short name: Help
PGxOne™ Plus
Specimen Source: Help
Who can order: Help
  • Health Care Provider
  • Licensed Physician
  • Nurse Practitioner
  • Physician Assistant
  • Registered Nurse
Contact Policy: Help
Laboratory can only accept contact from health care providers. Patients/families are encouraged to discuss genetic testing options with their health care provider.
How to Order: Help
Test service: Help
Clinical Testing/Confirmation of Mutations Identified Previously
Pharmacogenomics
Result interpretation
Test development: Help
Test developed by laboratory (no manufacturer test name)
Informed consent required: Help
Yes
Test strategy: Help
Targeted next-generation sequencing panel
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
Recommended fields not provided:
Conditions Help
Total conditions: 99
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 16
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 4
Method Category Help
Test method Help
Instrument
Targeted variant analysis
CNV Detection
Targeted variant analysis
Next Generation Sequencing
Targeted variant analysis
Quantitative PCR (qPCR)
Targeted variant analysis
SNP Detection
Illumina MiSeq® System
Clinical Information
Test purpose: Help
Drug Response; Therapeutic management
Clinical validity: Help
Pharmacogenomics testing to assess how a patient may respond to prescribed drugs was performed by massively parallel Next Generation Sequencing (NGS). PGxOne™ Plus was developed, and assessed for accuracy and precision by Admera Health, South Plainfield NJ. The sensitivity and specificity of this test are 100% and 100% respectively. The … View more
Clinical utility: Help
Guidance for selecting a drug therapy and/or dose
View citations (1)
  • Associated drugs carry pharmacogenomics recommendations put forth by the Food and Drug Administration (FDA).

Target population: Help
Patients taking or expecting to take medications included on the PGx One™ Plus test. See Conditions/Phenotypes section. Patients diagnosed with a condition in the therapeutic areas included in the PGxOne™ Plus test. See the Conditions/Phenotypes section.
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS? Help
Not Applicable for PGxOne™ Plus due to the test being a genotyping assay.

Are family members with defined clinical status recruited to assess significance of VUS without charge? Help
Not Applicable

Will the lab re-contact the ordering physician if variant interpretation changes? Help
Not provided. Not Applicable
Research:
Is research allowed on the sample after clinical testing is complete? Help
Not Applicable
Recommended fields not provided:
Technical Information
Test Procedure: Help
Next-generation sequencing is used for confirmation of novel alleles.
Test Confirmation: Help
Sanger Sequencing and qPCR are used to confirm novel alleles detected via Next-Generation Sequencing.
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
Genomic DNA samples purchased from Coriell institute or extracted from various types of specimen collected from anonymized donors were used. The NGS results were compared for concordance with bi-directional Sanger sequencing and qPCR results to indicate 100% concordance.
Assay limitations: Help
Admera Health’s PGxOne™ Plus test has an accuracy rating of > 99% specificity and sensitivity. PGxOne™ Plus currently does not detect hybrid alleles. A normal (negative) genotype signifies the absence of assay-specific alleles and does not indicate the absence of other mutations not covered by the assay. The possibility cannot … View more
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Formal PT program

PT Provider: Help
American College of Medical Genetics / College of American Pathologists, ACMG/CAP

Description of PT method: Help
We take Proficiency testing twice a year from CAP. Each time we received three genomic DNA samples and processed them as patient samples. Our PT pass rate for PGx is 100%.

Description of internal test validation method: Help
The PGxOne™ Plus tests were analytically validated using reference materials recommended by CDC and purchased from Coriell Institute and the sample collected from anonymized donors. Sensitivity, specificity, accuracy, and precision were evaluated by comparing NGS assay results to other standard genotyping methods, such as Sanger sequencing and qPCR.
VUS:
Laboratory's policy on reporting novel variations Help
Not Applicable
Recommended fields not provided:
Regulatory Approval
FDA Review: Help
Category: FDA exercises enforcement discretion
NYS CLEP Approval: Help
Number: 8972
Status: Approved
Additional Information

IMPORTANT NOTE: NIH does not independently verify information submitted to GTR; it relies on submitters to provide information that is accurate and not misleading. NIH makes no endorsements of tests or laboratories listed in 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.