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 Content is derived from published guidelines and regulatory sources and may contain errors or outdated information.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 I
Involvement of a single lymph node region (I) or single extralymphatic organ/site (IE). Limited disease — often treated with combined modality or abbreviated systemic therapy.
3 test recommendations across 1 clinical indication
Limited-stage MCL (rare, <10%). t(11;14) FISH required for diagnosis. Ki-67 and TP53 risk stratification performed even in limited disease.
Required — 2 tests
BCL2/BCL6/MYC FISH Panel
Double/Triple-Hit FISH
FISH panel detecting rearrangements of MYC (8q24), BCL2 (18q21), and BCL6 (3q27). MYC + BCL2 rearrangements define double-hit lymphoma (DHL); MYC + BCL2 + BCL6 define triple-hit lymphoma (THL). Both are reclassified as High-Grade B-Cell Lymphoma (HGBL) per WHO 2022 and require intensified induction (DA-EPOCH-R). Required for all newly diagnosed DLBCL.
Ordering Note
Required for MCL diagnosis. t(11;14) FISH (CCND1-IGH rearrangement) confirms MCL. Rare cyclin D1-negative MCL may require additional SOX11 IHC. NCCN MCL v2.2024 Category 1.
Specimen
Evidence
Ki-67 Proliferation Index (IHC)
Ki-67
IHC measurement of MKI67 nuclear antigen, reflecting proliferating cell fraction. In MCL: Ki-67 ≥30% = MIPI-b high risk; ≥50% = blastoid/pleomorphic variant. In FL: Ki-67 >20% raises concern for Grade 3B or transformation. In DLBCL: Ki-67 >90% suggests very aggressive biology.
Ordering Note
Required. Ki-67 is the primary prognostic biomarker in MCL. Ki-67 ≥30% = MIPI-b high risk. Ki-67 ≥50% indicates aggressive/blastoid MCL variant. NCCN Category 1.
Specimen
Evidence
Recommended — 1 test
TP53 Mutation Analysis
TP53
Sequencing of TP53 (17p13.1) for somatic mutations and copy number loss. In MCL: TP53 mutation (~15–20%) is the strongest adverse prognostic factor, predicting chemotherapy resistance and inferior BTK inhibitor outcomes. TP53-mutant MCL requires novel approaches (venetoclax, CAR-T, clinical trial). In FL: TP53 mutation increases transformation risk.
Ordering Note
Recommended for all MCL (NCCN Category 2A). TP53 mutation is the strongest adverse prognostic factor in MCL — identifies candidates for novel therapies (venetoclax, CAR-T) over conventional chemotherapy.
Specimen
Evidence
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 |
|---|---|---|---|---|---|---|
| Double/Triple-Hit FISH | Covered | Covered | Covered | Covered | Covered | Covered |
| Ki-67 | Covered | Covered | Covered | Unknown | Unknown | Unknown |
| TP53 | 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.