genoCDS

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 Content is derived from published guidelines and regulatory sources and may contain errors or outdated information.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 →

Non-Small Cell Lung Cancer · Squamous Cell Carcinoma

Stage Stage IIA

Tumor >4–5 cm, no nodal or distant metastasis (T2b, N0, M0). Resectable.

2 test recommendations across 1 clinical indication

At Diagnosis

Resectable Stage IIA squamous cell carcinoma. PD-L1 IHC required — adjuvant pembrolizumab approved for resected Stage IB–IIIA squamous NSCLC regardless of PD-L1 expression (KEYNOTE-091). EGFR mutation testing recommended (less common in squamous but actionable when present).

Required 1 test

RequiredFDA Companion Dx

PD-L1 Expression by Immunohistochemistry (IHC)

PD-L1 IHC

LOINC 85147-7

Measurement of PD-L1 (programmed death-ligand 1; CD274) protein expression on tumor cells by IHC. Reported as Tumor Proportion Score (TPS) for NSCLC. Key thresholds: TPS <1% (PD-L1 negative), TPS 1–49% (low expression), TPS ≥50% (high expression). FDA-approved companion diagnostics: 22C3 pharmDx (pembrolizumab), 28-8 pharmDx (nivolumab), SP142 (atezolizumab), SP263 (durvalumab). PD-L1 ≥50% qualifies for pembrolizumab monotherapy first-line; all TPS levels are relevant for combination chemo-immunotherapy selection.

Ordering Note

KEYNOTE-091 (PEARLS): adjuvant pembrolizumab approved for resected Stage IB–IIIA NSCLC including squamous, regardless of PD-L1 expression. PD-L1 required.

Specimen

FFPE tumor tissue (≥1% tumor)Cell block (cytology)

Recommended 1 test

RecommendedFDA Companion Dx

EGFR Mutation Analysis

EGFR

LOINC 81227-6

Analysis of EGFR gene for sensitizing mutations in exons 18–21 (exon 19 deletions, exon 21 L858R, exon 18 G719X/S768I/L861Q, exon 20 insertions) and resistance mutations (T790M, C797S). May be performed by PCR-based assay or as part of an NGS panel. Cobas EGFR Mutation Test v2 is FDA-approved companion diagnostic for osimertinib (Tagrisso). EGFR mutations are present in 10–15% of Caucasian patients and 30–40% of Asian patients with adenocarcinoma.

Ordering Note

EGFR mutations occur in ~5% of squamous NSCLC (more common in never-smokers, Asian patients). If EGFR+ confirmed, adjuvant osimertinib may be indicated. Testing recommended especially in never-smokers and patients of Asian ancestry.

Specimen

FFPE tumor tissue (≥10% tumor)Liquid biopsy (ctDNA)Bronchial washings or brushings

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.

TestMedicare (CMS)UnitedHealthAnthem BCBSHumanaCignaAetna
PD-L1 IHCCoveredCoveredCoveredCoveredCoveredCovered
EGFRCoveredCoveredCoveredCoveredCoveredCovered

Coverage data last verified via automated policy research. Always confirm current policies with each payer.

Reference only. Testing guidance shown is derived from published clinical guidelines and regulatory sources. It does not constitute a clinical recommendation for any individual patient. Payer coverage information is a general summary and may not reflect current policy or individual benefit design. Full disclaimer

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.

Squamous Cell Carcinoma — Stage IIA | Non-Small Cell Lung Cancer | genoCDS | genoCDS