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geneType for type 2 diabetes
Clinical Genetic Test
Help
offered by
Phenogen Sciences Laboratories
View lab's test page
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GTR Test Accession: Help GTR000607903.1
Registered in GTR: 2023-06-13
View version history
Last annual review date for the lab: 2024-06-06 LinkOut
At a Glance
Test purpose: Help
Risk Assessment
Conditions (1): Help
Diabetes mellitus type 2, susceptibility to
Analytes (1): Help
DNA
Methods (1): Help
Molecular Genetics - Targeted variant analysis: SNP Detection
Target population: Help
Adults aged 40 to 85
Clinical validity: Help
Assessment of clinical validity of a type 2 diabetes risk …
Clinical utility: Help
Sufficient research has not been conducted to demonstrate the utility of the test
Ordering Information
Offered by: Help
Phenogen Sciences Laboratories
View lab's website
View lab's test page
Specimen Source: Help
Who can order: Help
  • Genetic Counselor
  • Health Care Provider
  • Licensed Physician
  • Nurse Practitioner
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
Clinician fills out requisition and submits to the lab. The lab will send a kit out to the clinician to collect saliva specimen from the patient. Kits may be stocked in office. The collected specimen is returned to the lab for processing.
Order URL
Test service: Help
Clinical Testing/Confirmation of Mutations Identified Previously
Test development: Help
Test developed by laboratory but exempt from FDA oversight (eg. NYS CLEP approved, offered within a hospital or clinic)
Informed consent required: Help
Based on applicable state law
Test strategy: Help
type 2 diabetesrisk assessment testing is available to general population women who are NOT carriers of a pathogenic variant associated with type 2 diabetes susceptibility.
View citations (1)
  • Gafni A, Dite GS, Spaeth Tuff E, Allman R, Hopper JL. Ability of known colorectal cancer susceptibility SNPs to predict colorectal cancer risk: A cohort study within the UK Biobank. PLoS One. 2021;16(9):e0251469. doi:10.1371/journal.pone.0251469. Epub 2021 Sep 15. PMID: 34525106.
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
Recommended fields not provided:
Test Order Code, Lab contact for this test
Conditions Help
Total conditions: 1
Condition/Phenotype Identifier
Test Targets
Analytes Help
Total analytes: 1
Analyte Associated Condition
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument
Targeted variant analysis
SNP Detection
Illumina HiScan™SQ system
Clinical Information
Test purpose: Help
Risk Assessment
Clinical validity: Help
Assessment of clinical validity of a type 2 diabetes risk model combining genetic and clinical information
View citations (1)
  • Wong CK, Makalic E, Dite GS, Whiting L, Murphy NM, Hopper JL, Allman R. Polygenic risk scores for cardiovascular diseases and type 2 diabetes. PLoS One. 2022;17(12):e0278764. doi:10.1371/journal.pone.0278764. Epub 2022 Dec 02. PMID: 36459520.
Clinical utility: Help
Sufficient research has not been conducted to demonstrate the utility of the test
View citations (1)

Target population: Help
Adults aged 40 to 85
View citations (1)
  • Wong CK, Makalic E, Dite GS, Whiting L, Murphy NM, Hopper JL, Allman R. Polygenic risk scores for cardiovascular diseases and type 2 diabetes. PLoS One. 2022;17(12):e0278764. doi:10.1371/journal.pone.0278764. Epub 2022 Dec 02. PMID: 36459520.
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS? Help
this test does not identify nor assess VUS

Will the lab re-contact the ordering physician if variant interpretation changes? Help
Not provided. Re-contact with the ordering physician will occur if any changes to the report are made
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 negative report, Sample positive report
Technical Information
Test Procedure: Help
Illumina array
Test Platform:
Illumina custom beadarray
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
>99% Accuracy, >95% Intra- & Inter- assay precision
View citations (1)
  • Wong CK, Makalic E, Dite GS, Whiting L, Murphy NM, Hopper JL, Allman R. Polygenic risk scores for cardiovascular diseases and type 2 diabetes. PLoS One. 2022;17(12):e0278764. doi:10.1371/journal.pone.0278764. Epub 2022 Dec 02. PMID: 36459520.
Assay limitations: Help
Cannot be used on adults with: a personal history of type 2 diabetes; a pathogenic variant in a type 2 diabetes susceptibility gene; an age under 40
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Internal Laboratory QA testing
Recommended fields not provided:
Test Confirmation, Citations to support assay limitations, Description of internal test validation method, PT Provider, Description of PT method, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Category: FDA exercises enforcement discretion
NYS CLEP Approval: Help
Number: 8705
Status: Pending
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.