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Cardio PGx Panel
Clinical Genetic Test
Help
offered by
Dynamic DNA Laboratories, LLC
View lab's test page
LinkOut
GTR Test Accession: Help GTR000604049.1
CAP
PHARMACOGENOMICINHERITED DISEASE
Registered in GTR: 2023-01-24
View version history
Last annual review date for the lab: 2023-12-07 LinkOut
At a Glance
Test purpose: Help
Drug Response
Conditions (16): Help
Flecainide response; Acenocoumarol response; Carvedilol response more...
Genes (6): Help
ATM (11q22.3); CYP2C19 (10q23.33); CYP2C9 (10q23.33); CYP2D6 (22q13.2); CYP3A4 (7q22.1) more...
Methods (2): Help
Molecular Genetics - Deletion/duplication analysis: RT-qPCR; ...
Target population: Help
Individuals currently taking multiple prescription medications or who have previously …
Clinical validity: Help
All drugs are metabolized to some extent in the human …
Clinical utility: Help
Guidance for selecting a drug therapy and/or dose
Ordering Information
Offered by: Help
Dynamic DNA Laboratories, LLC
View lab's website
View lab's test page
Test short name: Help
Cardio
Specimen Source: Help
  • Buccal swab
Who can order: Help
  • Health Care Provider
  • Licensed Physician
  • Nurse Practitioner
  • Physician Assistant
Lab contact: Help
Jacob Norton, MS, FCAP, Lab Manager
rhy@dynamicdnalabs.com
417-319-1047
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
Contact laboratory to receive requisition form. If this is the first time ordering, a new
account setup form is also required. Kits for buccal cell collection are provided along
with pre-paid and pre-labeled return mailers.
Order URL
Test service: Help
Clinical Testing/Confirmation of Mutations Identified Previously
    Comment: Pharmacogenomic Testing
Test development: Help
Test developed by laboratory (no manufacturer test name)
Informed consent required: Help
Yes
Test strategy: Help
Order test before prescribing high risk medication. Only final reports are issued.
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
Conditions Help
Total conditions: 16
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 6
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 2
Method Category Help
Test method Help
Instrument
Deletion/duplication analysis
RT-qPCR
Other
Targeted variant analysis
Microarray
Illumina iScan
Clinical Information
Test purpose: Help
Drug Response
Clinical validity: Help
All drugs are metabolized to some extent in the human body. Nearly all of the enzymes and transporters involved in drug metabolism are known to contain genetic polymorphisms across the human population. Some of these polymorphisms are known to contribute to altered function and subsequent altered drug metabolism. Therefore, determination … View more
View citations (2)
  • DOI: 10.1007/s40256-013-0024-5
  • DOI: 10.1186/gm499
Clinical utility: Help
Guidance for selecting a drug therapy and/or dose
View citations (1)

Target population: Help
Individuals currently taking multiple prescription medications or who have previously had an adverse drug event (ADE).
View citations (1)
  • DOI: 10.1371/journal.pone.0164972
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS? Help
VUS are not identified in this testing.

Will the lab re-contact the ordering physician if variant interpretation changes? Help
Not provided. Laboratory will need to be recontacted for new interpretations.
Sample reports:
Sample Negative Report Help
Revised report requested by NCBI
Recommended fields not provided:
Are family members with defined clinical status recruited to assess significance of VUS without charge?, Will the lab re-contact the ordering physician if variant interpretation changes?, Is research allowed on the sample after clinical testing is complete?, Sample positive report
Technical Information
Test Procedure: Help
Buccal swabs are used as the specimen type. Genomic DNA is extracted from buccal swabs using an ABI magnetic particle processor (MagMAX). Purified DNA is then quantified using qPCR. Microarray analysis is then performed using the Illumina Global Screening Array v3 (w/DTC booster) beadchip and the Illumina iScan. CYP2D6 copy … View more
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
The minimum concentration of this assay was validated using 384 samples and was determine to be between 2.5 ng/uL and 50 ng/uL. Qualitative reproducibility was determined to be 99.90% percent using a total of 12 samples and over 7.9 million genotypes in total. Qualitative accuracy was determined by testing 382 … View more
View citations (1)
  • DOI: 10.1002/mgg3.2016
Assay limitations: Help
Extracted samples with a DNA concentration below 2.5 ng/uL are unable to be tested. Additionally, this assay does not detect genetic variants other than those listed on the report.
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Formal PT program

PT Provider: Help
College of American Pathologists, CAP

Description of PT method: Help
Formal PT is performed using the APOE, MGL1, and PGX products available from the College of American Pathologists. Each program consists of two sets of challenges per year, with each challenge consisting of three samples. Assays that are not covered in a formal PT program are subject to an in-house … View more

Description of internal test validation method: Help
Prior to patient testing an internal validation was designed using the parameters set forth by the College of American Pathologists (CAP). This validation meets or exceeds all defined parameters. Additional validations are performed per processing cycle that consists of negative (no template controls) and positive (samples of known genotypes) reactivity.
VUS:
Software used to interpret novel variations Help
Coriell Life Sciences API

Laboratory's policy on reporting novel variations Help
Novel variants are not identified in this testing.
Recommended fields not provided:
Test Confirmation, Citations to support assay limitations, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Category: Not Applicable
Additional Information
Consumer resources:

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.