genoCDS

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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 Content is derived from published guidelines and regulatory sources and may contain errors or outdated information.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 · NSCLC, Not Otherwise Specified (NOS)

Stage Stage IVB

Multiple extrathoracic metastases in one or more organs. Widely metastatic disease.

2 test recommendations across 1 clinical indication

At Diagnosis

Stage IVB NSCLC NOS. Same approach as Stage IVA NOS.

Required 2 tests

RequiredFDA Companion Dx

Comprehensive Solid Tumor NGS Panel

Comprehensive NGS

LOINC 81445-4

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.

Specimen

FFPE tumor tissue (≥20% tumor)Liquid biopsy (ctDNA)Fresh/frozen tumor tissue
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.

Specimen

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

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
Comprehensive NGSCoveredCoveredCoveredPrior AuthCoveredCovered
PD-L1 IHCCoveredCoveredCoveredCoveredCoveredCovered

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.

NSCLC, Not Otherwise Specified (NOS) — Stage IVB | Non-Small Cell Lung Cancer | genoCDS | genoCDS