Medical Disclaimer
genoCDS is a clinical reference tool for qualified healthcare professionals only. Content is derived from published guidelines and regulatory sources and may contain errors or outdated information. It is not a substitute for professional medical judgment, institutional protocols, or individual patient assessment. Always verify recommendations against current primary sources before making clinical decisions. Full disclaimer →
Stage Stage IIA
Tumor >4–5 cm, no nodal or distant metastasis (T2b, N0, M0). Resectable.
3 test recommendations across 1 clinical indication
Stage IIA HR+/HER2−. Oncotype DX recommended for pT1b-pT2 pN0 or pN1a (1-3 nodes). Guides adjuvant chemotherapy decision per TAILORx/RxPONDER data.
Required — 2 tests
HER2 Testing (IHC + FISH)
HER2 IHC/FISH
HER2 (ERBB2) status testing by immunohistochemistry (IHC) with reflex to FISH for IHC 2+ equivocal results, per ASCO/CAP 2018 guidelines. IHC 3+ = HER2 positive. FISH amplification ratio ≥2.0 or average HER2 copy number ≥6.0 signals/cell = HER2 positive. IHC 1+ and 2+/FISH non-amplified = HER2 low (eligible for T-DXd). Required for all newly diagnosed invasive breast cancer. FDA-approved companion diagnostic for multiple HER2-targeted therapies.
Specimen
Oncotype DX Recurrence Score (21-Gene Assay)
Oncotype DX
Gene expression profiling assay measuring 21 genes to generate a Recurrence Score (RS 0–100) predicting 10-year distant recurrence risk and chemotherapy benefit in HR+/HER2− early breast cancer. Low RS (0–25, postmenopausal; 0–15, premenopausal): endocrine therapy only. High RS (≥26, postmenopausal; ≥16, premenopausal): adjuvant chemotherapy plus endocrine therapy. TAILORx (N Engl J Med 2018) and RxPONDER (N Engl J Med 2021) established evidence base. NCCN Category 1 for pT1b-pT2, pN0-N1a.
Ordering Note
NCCN Category 1 for pT1b-pT2 pN0-N1a. RxPONDER showed chemotherapy benefit in premenopausal RS ≥16, all node-positive.
Specimen
Evidence
NCCN Category 1: Oncotype DX RS for pT1b-pT2 pN0-N1a HR+/HER2−. TAILORx and RxPONDER trial evidence.
Optional — 1 test
Comprehensive Solid Tumor NGS Panel
Comprehensive NGS
Next-generation sequencing panel covering ≥300 cancer-relevant genes, including all major NSCLC drivers (EGFR, ALK, ROS1, BRAF, KRAS, MET, RET, NTRK, HER2, FGFR), plus tumor mutational burden (TMB) and microsatellite instability (MSI). Examples include FoundationOne CDx, Tempus xT, Caris MI Transcriptome, and equivalent institutional panels. Preferred over single-gene sequential testing for efficiency and cost-effectiveness.
Ordering Note
Consider if clinical trial eligibility is a priority or if germline testing reflex is warranted.
Specimen
Payer Coverage
Payer Coverage Summary
Coverage status as of last policy review. Prior authorization requirements and coverage criteria may change. Verify directly with each payer before ordering.
| Test | Medicare (CMS) | UnitedHealth | Anthem BCBS | Humana | Cigna | Aetna |
|---|---|---|---|---|---|---|
| HER2 IHC/FISH | Covered | Covered | Covered | Unknown | Unknown | Unknown |
| Oncotype DX | Covered | Covered | Covered | Covered | Covered | Covered |
| Comprehensive NGS | Covered | Covered | Covered | Prior Auth | Covered | Covered |
Coverage data last verified via automated policy research. Always confirm current policies with each payer.
Recommendations on this page are derived from publicly available guidelines (NCCN, ASCO, ESMO, FDA, OncoKB) and are paraphrased for reference. They do not constitute medical advice. Evidence levels reflect the grading systems of each respective organization and should be interpreted in clinical context. This reference is updated periodically but may not reflect the most recent guideline revisions.