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Breast Cancer Prognostic Gene Signature Assay (Prosigna®), IVD
Clinical Genetic Test
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offered by
Molecular Oncology Laboratory, LabCorp
View lab's test page
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GTR Test Accession: Help GTR000569904.3
BREAST DISORDERSCANCER
Last updated in GTR: 2021-06-09
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Last annual review date for the lab: 2024-12-07 LinkOut
At a Glance
Test purpose: Help
Prognostic
Conditions (1): Help
Breast neoplasm
Analytes (1): Help
RNA - PAM50
Methods (1): Help
Molecular Genetics - Targeted variant analysis: PCR
Target population: Help
Not provided
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
Molecular Oncology Laboratory, LabCorp
View lab's test page
Specimen Source: Help
  • Paraffin block
Test Order Code: Help
481210
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.
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:
How to Order, 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 *
Targeted variant analysis
PCR
* Instrument: Not provided
Clinical Information
Test purpose: Help
Prognostic
Recommended fields not provided:
Clinical validity, Clinical utility, Target population, 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
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
Prosigna’s clinical performance has been validated in two large independent studies using retrospective tissue samples from over 2,400 patients within the intended use population which is post-menopausal women with hormone receptor positive early stage breast cancer. Both studies demonstrated that the Prosgina score provided substantial prognostic information over and above … View more
View citations (1)
  • Dowsett M, Sestak I, Lopez-Knowles E, Sidhu K, Dunbier AK, Cowens JW, Ferree S, Storhoff J, Schaper C, Cuzick J. Comparison of PAM50 risk of recurrence score with oncotype DX and IHC4 for predicting risk of distant recurrence after endocrine therapy. J Clin Oncol. 2013;31(22):2783-90. doi:10.1200/JCO.2012.46.1558. Epub 2013 Jul 01. PMID: 23816962.
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Intra-Laboratory
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
Not provided
Additional Information

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.