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Prolaris
Clinical Genetic Test
Help
offered by
Myriad Genetics, Inc.
View lab's test page
LinkOut
GTR Test Accession: Help GTR000603551.1
NYS CLEP
CANCERREPRODUCTIVE HEALTH
Registered in GTR: 2022-11-18
View version history
Last annual review date for the lab: 2023-12-27 LinkOut
At a Glance
Test purpose: Help
Prognostic; Therapeutic management
Conditions (1): Help
Malignant tumor of prostate
Analytes (1): Help
46-gene RNA Expression Based Prolaris Score
Methods (1): Help
Molecular Genetics - RNA analysis: RT-qPCR
Target population: Help
Patients with a prostate cancer diagnosis.
Clinical validity: Help
Not provided
Clinical utility: Help
Guidance for management
Ordering Information
Offered by: Help
Myriad Genetics, Inc.
View lab's website
View lab's test page
Specimen Source: Help
Who can order: Help
  • Health Care Provider
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
Licensure is state dependant. All healthcare providers who are licenced to order genetic testing in their state may order this testing.
Order URL
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 Order Code, Lab contact for this test, Test strategy, Test development
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 *
RNA analysis
RT-qPCR
* Instrument: Not provided
Clinical Information
Test purpose: Help
Prognostic; Therapeutic management
Clinical utility: Help
Guidance for management
View citations (1)

Target population: Help
Patients with a prostate cancer diagnosis.
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?, Sample negative report, Sample positive report
Technical Information
Test Comments: Help
Previousy registered in GTR as GTR000553157
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
The analytical validity of the Prolaris gene expression signature has been performed and published in a peer-reviewed manner. This validation includes: 1) assessment of the precision 2) reproducibility data 3) dynamic range of the assay. It also reports data around the stability and linearity of RNA extracted from formalin-fixed paraffin-embedded … View more
View citations (2)
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Alternative Assessment
Recommended fields not provided:
Test Confirmation, 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: 28306
Status: Approved
Additional Information

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