geneType for prostate cancer
GTR Test Accession: Help GTR000607898.1
Last updated in GTR: 2023-06-13
Last annual review date for the lab: 2024-06-06 LinkOut
At a Glance
Risk Assessment
RECLASSIFIED - CDH1 POLYMORPHISM
DNA
Molecular Genetics - Targeted variant analysis: SNP Detection
Men aged 30 to 85
Assessment of clinical validity of a prostate cancer risk model …
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
Prostate cancer risk assessment testing is available to general population men who are NOT carriers of a pathogenic variant associated with prostate cancer susceptibility.
View citations (1)
  • Dite GS, Spaeth E, Murphy NM, Allman R. Development and validation of a simple prostate cancer risk prediction model based on age, family history, and polygenic risk. Prostate. 2023;83(10):962-969. doi:10.1002/pros.24537. Epub 2023 Apr 16. PMID: 37062910.
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
Recommended fields not provided:
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 prostate cancer risk model combining genetic and clinical information
View citations (1)
  • Dite GS, Spaeth E, Murphy NM, Allman R. Development and validation of a simple prostate cancer risk prediction model based on age, family history, and polygenic risk. Prostate. 2023;83(10):962-969. doi:10.1002/pros.24537. Epub 2023 Apr 16. PMID: 37062910.
Clinical utility: Help
Sufficient research has not been conducted to demonstrate the utility of the test

Target population: Help
Men aged 30 to 85
View citations (1)
  • Dite GS, Spaeth E, Murphy NM, Allman R. Development and validation of a simple prostate cancer risk prediction model based on age, family history, and polygenic risk. Prostate. 2023;83(10):962-969. doi:10.1002/pros.24537. Epub 2023 Apr 16. PMID: 37062910.
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:
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)
  • Dite GS, Spaeth E, Murphy NM, Allman R. Development and validation of a simple prostate cancer risk prediction model based on age, family history, and polygenic risk. Prostate. 2023;83(10):962-969. doi:10.1002/pros.24537. Epub 2023 Apr 16. PMID: 37062910.
Assay limitations: Help
Cannot be used on adults with: a personal history of prostate cancer; a pathogenic variant in a prostate cancer susceptibility gene; an age under 30
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:
Regulatory Approval
FDA Review: Help
Category: FDA exercises enforcement discretion
NYS CLEP Approval: Help
Number: 8705
Status: Pending
Additional Information
Practice guidelines:
Consumer resources:

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