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Oncotype DX Colon Recurrence Score Test
Clinical Genetic Test
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offered by
Genomic Health Precision Oncology Laboratory, Redwood City
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GTR Test Accession: Help GTR000527839.10
CAP
CANCERDIGESTIVE SYSTEM
Last updated in GTR: 2024-07-17
View version history
Last annual review date for the lab: 2024-07-19 LinkOut
At a Glance
Test purpose: Help
Prognostic; Therapeutic management
Conditions (1): Help
Colon cancer
Analytes (1): Help
12-gene Colon Recurrence Score
Methods (1): Help
Molecular Genetics - RNA analysis: RT-qPCR
Target population: Help
Newly diagnosed with anatomic stage II, T3, MMR-P or stage …
Clinical validity: Help
The Oncotype DX Colon Recurrence Score assay has been clinically …
Clinical utility: Help
Guidance for management
Ordering Information
Offered by: Help
Genomic Health Precision Oncology Laboratory, Redwood City
View lab's website
View lab's test page
Specimen Source: Help
  • Paraffin block
Who can order: Help
  • Health Care Provider
Contact Policy: Help
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.
How to Order: Help
Order URL
Informed consent required: Help
Yes
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
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 validity: Help
The Oncotype DX Colon Recurrence Score assay has been clinically validated as a predictor of recurrence risk in stage II and III colon cancer. For more info on clinical validity, visit: https://precisiononcology.exactsciences.com/healthcare-providers/treatment-determination/colon-cancer/oncotype-dx-colon-recurrence-score/clinical-utility URL for publication links also involved in clinical validity: https://www.exactsciences.com/publications/list?cancer_type=Colorectal%20Cancer&product_type=Product&product=Oncotype%20DX%20Colon%20Recurrence%20Score%20test
Clinical utility: Help
Guidance for management
View citations (1)

Target population: Help
Newly diagnosed with anatomic stage II, T3, MMR-P or stage III A/B colon cancer patients For information about patient eligibility, visit: https://precisiononcology.exactsciences.com/healthcare-providers/treatment-determination/colon-cancer/oncotype-dx-colon-recurrence-score
Recommended fields not provided:
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
For a description of the Oncotype DX Colon test, please visit: https://precisiononcology.exactsciences.com/healthcare-providers/treatment-determination/colon-cancer/oncotype-dx-colon-recurrence-score
Test Confirmation: Help
For information on interpreting test results, visit: https://precisiononcology.exactsciences.com/healthcare-providers/treatment-determination/colon-cancer/oncotype-dx-colon-recurrence-score/explore-the-results
Test Comments: Help
For information on reimbursement and insurance, please visit: https://precisiononcology.exactsciences.com/billing-financial-coverage
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
Analytical validity (1) involves characterization of the accuracy, precision, and reproducibility of the assay required for its intended use. The analytical validity of the Oncotype DX Colon Recurrence Score assay has been reported in peer-reviewed literature. To read more about the analytical and clinical validity of this product, visit: https://precisiononcology.exactsciences.com/healthcare-providers/treatment-determination/colon-cancer/oncotype-dx-colon-recurrence-score/clinical-utility … View more
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Formal PT program

PT Provider: Help
American College of Medical Genetics / College of American Pathologists, ACMG/CAP

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=Colorectal%20Cancer&product_type=Product&product=Oncotype%20DX%20Colon%20Recurrence%20Score%20test
Recommended fields not provided:
Assay limitations, Citations to support internal test validation method, Citations for Analytical validity, Description of PT method, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Not provided
Additional Information
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.