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Gravity Pharmacogenetics Comprehensive Profile
Clinical Genetic Test
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offered by
Gravity Diagnostics
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GTR Test Accession: Help GTR000604268.2
NYS CLEP
CAP
PHARMACOGENOMICINHERITED DISEASEINHERITED DISEASE SUSCEPTIBILITY ... View more
Last updated in GTR: 2023-04-10
View version history
Last annual review date for the lab: 2024-03-06 LinkOut
At a Glance
Test purpose: Help
Drug Response
Conditions (86): Help
Selective serotonin reuptake inhibitor response; Acenocoumarol response; Amitriptyline response; ...
Genes (17): Help
ABCB1 (7q21.12), ABCG2 (4q22.1), ADRA2A (10q25.2), APOE (19q13.32), COMT (22q11.21), ...
Methods (1): Help
Molecular Genetics - Targeted variant analysis: Allele-specific primer extension (ASPE)
Target population: Help
Patients who are on or considering a medication with a …
Clinical validity: Help
Not provided
Clinical utility: Help
Guidance for selecting a drug therapy and/or dose
Ordering Information
Offered by: Help
Gravity Diagnostics
View lab's website
View lab's test page
Specimen Source: Help
Who can order: Help
  • Health Care Provider
  • Licensed Physician
  • Nurse Practitioner
  • Physician Assistant
Test Order Code: Help
GD Pharmacogenetics Comprehensive Profile
Lab contact: Help
James Canner, PhD, Lab Director
info@gravitydiagnostics.com
855-841-7111
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
Order URL
Test service: Help
Clinical Testing/Confirmation of Mutations Identified Previously
Test development: Help
Test developed by laboratory (no manufacturer test name)
Informed consent required: Help
Decline to answer
Pre-test genetic counseling required: Help
Decline to answer
Post-test genetic counseling required: Help
Decline to answer
Recommended fields not provided:
Test strategy
Conditions Help
Total conditions: 86
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 17
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument
Targeted variant analysis
Allele-specific primer extension (ASPE)
Agena Biosciences MassARRAY
Clinical Information
Test purpose: Help
Drug Response
Clinical utility: Help
Guidance for selecting a drug therapy and/or dose
View citations (1)

Target population: Help
Patients who are on or considering a medication with a CPIC level A or B pharmacogenetic interaction.
View citations (1)
  • A 12-gene pharmacogenetic panel to prevent adverse drug reactions: an open-label, multicentre, controlled, cluster-randomised crossover implementation study. Swen JJ, et al. Lancet. 2023;401(10374):347-356. doi:10.1016/S0140-6736(22)01841-4. PMID: 36739136.
Sample reports:
Sample Negative Report Help
Sample Negative Report

Sample Positive Report Help
Sample Positive Report
Recommended fields not provided:
Clinical validity, What is the protocol for interpreting a variation as a VUS?, 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?
Technical Information
Test Procedure: Help
Brief, DNA is isolated from buccal swabs followed up multiple PCR reaction to amplify regions containing functionally defined SNPs. The amplification reactions are treated with phosphatase and a single base extension reaction is conducted with the oligonucleotide adjacent to the SNP of interest. The reaction is desalted and then subjected … View more
View citations (1)
  • Scott SA, Scott ER, Seki Y, Chen AJ, Wallsten R, Owusu Obeng A, Botton MR, Cody N, Shi H, Zhao G, Brake P, Nicoletti P, Yang Y, Delio M, Shi L, Kornreich R, Schadt EE, Edelmann L. Development and Analytical Validation of a 29 Gene Clinical Pharmacogenetic Genotyping Panel: Multi-Ethnic Allele and Copy Number Variant Detection. Clin Transl Sci. 2021;14(1):204-213. doi:10.1111/cts.12844. Epub 2020 Aug 05. PMID: 32931151.
Test Platform:
Agena Biosciences MassARRAY
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
Analytical accuracy was determined by analyzing 42 specimens with known genetic results through either published references (29 specimens) or a previously validated clinical laboratory test (13 specimens). Precision studies consisted of 4 specimens being run two separate days by two separate clinical laboratory scientist each day for a total of … View more
View citations (1)
  • Association of Molecular Pathologist. Molecular Diagnostics Assay Validation – September 2014 AMP White Paper
Assay limitations: Help
Certain SNP assays had no minor alleled verified during the validations due to the minor allele fraction being 0.000231 or less. A list of these SNPs are available upon request.
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
Formal CAP proficiency testing is conducted for any genes present on those surveys. All other genes undergo an alternative PT assessment semi-annually.
Recommended fields not provided:
Test Confirmation, Citations to support assay limitations, Description of internal test validation method, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Category: Not Applicable
NYS CLEP Approval: Help
Number: 91239
Status: Approved
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.