Oncotype DX Breast Recurrence Score Report Interpreter

What this interpreter does

The Oncotype DX Breast Recurrence Score Report Interpreter accepts an integer score from a final external Exact Sciences report and identifies the applicable source row:

• TAILORx N0: score 0-10 was assigned to an endocrine-therapy cohort, 11-25 was randomized, and 26-100 was assigned to a chemoendocrine cohort.
• TAILORx age boundary: age 50 belongs to the <=50 analysis and age 51 to the >50 analysis. The 16-20 and 21-25 observations in younger participants were exploratory and are not individualized benefit estimates.
• RxPONDER N1: only scores 0-25 with one to three positive nodes were studied. Postmenopausal participants had no chemotherapy benefit demonstrated; premenopausal participants had improved invasive disease-free and distant relapse-free survival observed.
• RxPONDER limitation: scores 26-100 are outside RxPONDER, not a node-positive benefit threshold. Relative chemotherapy benefit did not increase with score from 0 through 25.

Required scope

The supported clinical context is an adult with postoperative, pre-adjuvant, early invasive HR-positive (ER and/or PR), HER2-negative Stage I, II, or IIIA breast cancer; planned endocrine therapy; and a final verified Exact Sciences result. Chronological age and menopausal status are separate inputs. Unknown required context returns Incomplete assessment. Known excluded disease or report context returns Outside validated scope. N4+, TAILORx age above 75, explicit outside-trial population, and RxPONDER score above 25 return Outside TAILORx/RxPONDER evidence scope while preserving the submitted score.

No unsupported clinical maximum age is imposed. Age above the direct TAILORx range is treated as an evidence limitation, not malformed solely because of age.

Version and report separation

The August 2025 Exact Sciences IVDR IFU Rev 7 is an international source document. Its report tables are not presented here as a definitive current US report layout. Historical 0-17/18-30/31-100 bands are also not merged with TAILORx or RxPONDER strata. The public N1 sample report does not support inventing an exact hidden US report revision.

Sources

1. Exact Sciences current Breast Recurrence Score page
2. Exact Sciences IVDR IFU Rev 7, August 2025
3. TAILORx primary report
4. TAILORx clinical and genomic risk analysis
5. RxPONDER primary report
6. ASCO 2022 biomarker guideline update
7. NICE HTG719

Verification boundary

The published dossier is source-to-code implementation verification, not independent clinical validation. Final management remains with the treating multidisciplinary team and the actual laboratory report.