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A gene expression profile test to resolve head & neck squamous versus lung squamous cancers
Anita Lal1, Rebecca Panos, Mira Marjanovic
1Pathwork Diagnostics, 595 Penobscot Dr, Redwood City, CA 94063, USA. anita.lal08@gmail.com
Diagnostic Pathology
|March 19, 2013
Summary
A new gene expression profile test (GEP-HN-LS) accurately distinguishes between head and neck squamous cell carcinomas (HNSCC) and lung squamous cell carcinomas (lung SCC). This molecular diagnostic tool aids in resolving difficult differential diagnoses for these similar-appearing tumors.
Area of Science:
- Molecular diagnostics
- Cancer genomics
- Pathology
Background:
- Histologic similarity between metastatic head and neck squamous cell carcinomas (HNSCC) and lung squamous cell carcinomas (lung SCC) complicates differential diagnosis.
- A validated gene expression profile test (GEP-HN-LS) using a 2160-gene model has been developed to differentiate these tumor types.
Purpose of the Study:
- To validate the GEP-HN-LS test for distinguishing HNSCC from lung SCC.
- To assess the diagnostic accuracy and reproducibility of the GEP-HN-LS test in formalin-fixed, paraffin-embedded (FFPE) specimens.
Main Methods:
- A blinded study utilized a pre-specified algorithm and microarray data from 76 metastatic or poorly-differentiated primary tumors with known HNSCC or lung SCC diagnoses.
- The GEP-HN-LS test was applied to FFPE specimens.
Main Results:
- The study met its primary Bayesian statistical endpoint.
- Overall agreement with known diagnoses was 82.9% (AUC 0.91, DOR 23.6).
- Reproducibility across three laboratories showed 91.7% concordance.
Conclusions:
- The GEP-HN-LS test is a valuable tool for differentiating HNSCC and lung SCC.
- This molecular assay can assist pathologists in resolving challenging differential diagnoses.
