Breast Cancer Prognostic Gene Signature Assay (Prosigna®), IVD
GTR Test Accession: Help GTR000569904.3
Last updated in GTR: 2021-06-09
Last annual review date for the lab: 2023-12-08 LinkOut
At a Glance
Breast neoplasm
Molecular Genetics - Targeted variant analysis: PCR
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Ordering Information
Offered by: Help
Molecular Oncology Laboratory, LabCorp
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Specimen Source: Help
Test Order Code: Help
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
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Pre-test genetic counseling required: Help
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Post-test genetic counseling required: Help
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Conditions Help
Total conditions: 1
Condition/Phenotype Identifier
Test Targets
Analytes Help
Total analytes: 1
Analyte Associated Condition
Total methods: 1
Method Category Help
Test method Help
Instrument *
Targeted variant analysis
* Instrument: Not provided
Clinical Information
Test purpose: Help
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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

Method used for proficiency testing: Help
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Regulatory Approval
FDA Review: Help
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Additional Information

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