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EndoPredict
Clinical Genetic Test
Help
offered by
Myriad Genetics, Inc.
View lab's test page
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GTR Test Accession: Help GTR000603549.1
NYS CLEP
BREAST DISORDERSCANCER
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
Therapeutic management; Recurrence; Prognostic
Conditions (1): Help
Breast neoplasm
Analytes (1): Help
Ribonucleic acid
Methods (1): Help
Molecular Genetics - RNA analysis: RT-qPCR
Target population: Help
Women with early-stage breast cancer with the following characteristics: ER+, …
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
  • Licensed Physician
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
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
Therapeutic management; Recurrence; Prognostic
Clinical utility: Help
Guidance for management
View citations (1)
  • EndoPredict provides an individualized probability of early and late recurrence for each patient based on their tumor’s biology and pathology. With the integration of these specific features, EndoPredict also accurately predicts an individualized absolute chemotherapy benefit to help make the right treatment decisions for each individual case of breast cancer.

Target population: Help
Women with early-stage breast cancer with the following characteristics: ER+, HER2-, node negative or node positive (up to 3 nodes).
View citations (1)
  • Dubsky P, Brase JC, Jakesz R, Rudas M, Singer CF, Greil R, Dietze O, Luisser I, Klug E, Sedivy R, Bachner M, Mayr D, Schmidt M, Gehrmann MC, Petry C, Weber KE, Fisch K, Kronenwett R, Gnant M, Filipits M, . The EndoPredict score provides prognostic information on late distant metastases in ER+/HER2- breast cancer patients. Br J Cancer. 2013;109(12):2959-64. doi:10.1038/bjc.2013.671. Epub 2013 Oct 24. PMID: 24157828.
Variant Interpretation:
Are family members with defined clinical status recruited to assess significance of VUS without charge? Help
Decline to answer.

Will the lab re-contact the ordering physician if variant interpretation changes? Help
Decline to answer.
Recommended fields not provided:
Clinical validity, What is the protocol for interpreting a variation as a VUS?, Is research allowed on the sample after clinical testing is complete?, Sample negative report, Sample positive report
Technical Information
Test Procedure: Help
Quantitative RT-PCR is used to measure, in triplicate, the expression of 8 signature genes, and 3 normalization genes, with 1 control gene to assess for DNA contamination. These molecular data are used to generate a 12- Gene Molecular Score. If tumor size and lymph node status are unavailable at the … View more
View citations (1)
Test Comments: Help
Previousy registered in GTR as GTR000569917; EndoPredict is intended for in vitro analysis of FFPE resection and biopsy specimens of primary female invasive breast cancer (estrogen receptor positive, HER2 negative), for the determination of the 10-year risk of distant recurrence (metastatic disease), the likelihood of distant recurrence 5-15 years after … View more
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
A set of 18 tumor samples, consisting of 14 resections and 4 biopsies, was tested 3 times, and the standard deviation of the 12-Gene Molecular Score was determined to be 0.21 score units. The standard deviation of the EPclin Risk Score was determined to be 0.06 score units. The signature … View more
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, Citations for Analytical validity, PT Provider, Description of PT method, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Not provided
NYS CLEP Approval: Help
Number: 57976
Status: Approved
Additional Information

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