Clinical Genetic Test
offered by
GTR Test Accession:
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GTR000509910.14
NYS CLEP
Last updated in GTR: 2024-07-17
View version history
GTR000509910.14, last updated: 2024-07-17
GTR000509910.13, last updated: 2023-07-20
GTR000509910.12, last updated: 2022-07-23
GTR000509910.11, last updated: 2021-12-10
GTR000509910.10, last updated: 2021-11-19
GTR000509910.9, last updated: 2021-09-01
GTR000509910.8, last updated: 2020-07-15
GTR000509910.7, last updated: 2018-08-01
GTR000509910.6, last updated: 2017-07-31
GTR000509910.5, last updated: 2016-08-19
GTR000509910.4, last updated: 2015-08-21
GTR000509910.3, last updated: 2015-03-10
GTR000509910.2, last updated: 2014-04-10
GTR000509910.1, last updated: 2014-04-10
Last annual review date for the lab: 2024-07-19
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At a Glance
Test purpose:
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Predictive;
Prognostic;
Recurrence; ...
Conditions (1):
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Breast neoplasm
Analytes (1):
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Ribonucleic acid
Methods (1):
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Molecular Genetics - RNA analysis: RT-qPCR
Target population: Help
Newly diagnosed ER+, HER2-, stage I-IIIA invasive breast cancer patients …
Clinical validity:
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The Oncotype DX Breast Recurrence Score test result (the Recurrence …
Clinical utility:
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Guidance for management
Ordering Information
Offered by:
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Specimen Source:
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- Paraffin block
Who can order: Help
- Health Care Provider
- Licensed Physician
Lab contact:
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Contact Policy:
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Post-test email/phone consultation regarding genetic test results and interpretation is provided to patients/families.
Pre-test email/phone consultation regarding genetic test results and interpretation is provided to patients/families.
Pre-test email/phone consultation regarding genetic test results and interpretation is provided to patients/families.
How to Order:
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Test development:
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Test developed by laboratory but exempt from FDA oversight (eg. NYS CLEP approved, offered within a hospital or clinic)
Informed consent required:
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Yes
Pre-test genetic counseling required:
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No
Post-test genetic counseling required:
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No
Recommended fields not provided:
Test Order Code,
Test strategy
Conditions
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Total conditions: 1
| Condition/Phenotype | Identifier |
|---|
Test Targets
Analytes
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Total analytes: 1
| Analyte | Associated Condition |
|---|
Methodology
Total methods: 1
Method Category
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Test method
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Instrument
RNA analysis
RT-qPCR
Other
Clinical Information
Test purpose:
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Predictive;
Prognostic;
Recurrence;
Therapeutic management
Clinical validity:
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The Oncotype DX Breast Recurrence Score test result (the Recurrence Score value) has been significantly correlated with distant breast cancer recurrence, breast cancer-specific survival, disease-free-survival and overall survival. Several studies demonstrate the clinical utility of the Breast Recurrence Score for providing a comprehensive and individualized risk assessment for early-stage invasive …
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Clinical utility:
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Target population:
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Newly diagnosed ER+, HER2-, stage I-IIIA invasive breast cancer patients
For information about patient eligibility, please visit:
https://precisiononcology.exactsciences.com/healthcare-providers/treatment-determination/breast-cancer/oncotype-dx-breast-recurrence-score
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS?
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Not applicable
Not applicable
Are family members with defined clinical status recruited to assess significance of VUS without charge?
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No. Not applicable
No. Not applicable
Will the lab re-contact the ordering physician if variant interpretation changes?
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No. Not applicable
No. Not applicable
Research:
Is research allowed on the sample after clinical testing is complete?
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No
No
Recommended fields not provided:
Sample negative report,
Sample positive report
Technical Information
Test Procedure:
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For step-by-step instructions for how to order the test, please visit: https://precisiononcology.exactsciences.com/healthcare-providers/treatment-determination/breast-cancer/oncotype-dx-breast-recurrence-score/how-to-order
Test Platform:
None/not applicable
Test Confirmation:
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For information on interpreting test results, please visit:
https://precisiononcology.exactsciences.com/healthcare-providers/treatment-determination/breast-cancer/oncotype-dx-breast-recurrence-score/interpret-the-results
Test Comments:
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For information regarding Oncotype DX insurance coverage and reimbursement, please visit: https://precisiononcology.exactsciences.com/billing-financial-coverage
Availability:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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Analytical validation (1) of the Oncotype DX Breast Recurrence Score assay has been described in multiple peer-reviewed publications. For more info on the analytical and clinical validity of this test, visit: https://precisiononcology.exactsciences.com/healthcare-providers/treatment-determination/breast-cancer/oncotype-dx-breast-recurrence-score/clinical-evidence/clinical-overview
Breast Recurrence Score publications, including analytical validation publications can be found here:
https://www.exactsciences.com/publications/list?cancer_type=Breast%20Cancer&product_type=Product&product=Oncotype%20DX%20Breast%20Recurrence%20Score%C2%AE%20test
Proficiency testing (PT):
Is proficiency testing performed for this test?
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Yes
Method used for proficiency testing: Help
Alternative Assessment
Description of PT method: Help
Alternative assessment using blind sample testing
Description of internal test validation method: Help
To see publications that detail Internal test validation method, please visit: https://www.exactsciences.com/publications/list?cancer_type=Breast%20Cancer&product_type=Product&product=Oncotype%20DX%20Breast%20Recurrence%20Score%C2%AE%20test
Yes
Method used for proficiency testing: Help
Alternative Assessment
Description of PT method: Help
Alternative assessment using blind sample testing
Description of internal test validation method: Help
To see publications that detail Internal test validation method, please visit: https://www.exactsciences.com/publications/list?cancer_type=Breast%20Cancer&product_type=Product&product=Oncotype%20DX%20Breast%20Recurrence%20Score%C2%AE%20test
VUS:
Software used to interpret novel variations
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Not applicable
Laboratory's policy on reporting novel variations Help
Not applicable
Not applicable
Laboratory's policy on reporting novel variations Help
Not applicable
Recommended fields not provided:
Assay limitations,
Citations to support internal test validation method,
Citations for Analytical validity,
PT Provider,
Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review:
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Category:
FDA exercises enforcement discretion
NYS CLEP Approval:
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Number:
8143
Status: Approved
Status: Approved
Additional Information
Reviews:
Clinical resources:
Practice guidelines:
Consumer resources:
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.