Multi-institutional multiplexed genetic analysis in lung adenocarcinoma (AC): The Lung Cancer Mutation Consortium (LCMC I) experience.

11030 Background: Molecular analysis of lung AC has become standard of care for therapy selection. LCMC I collectively enrolled 1102 patients from 14 institutions with the goal of performing molecular analysis to identify therapy options. Technical aspects of the genomic testing, specimen and clinical correlations are presented. Methods: Testing for mutations in 8 genes (EGFR, KRAS, ERBB2, AKT1, BRAF, MEK1, NRAS, PIK3CA), and analysis of ALK and MET by FISH, was performed at 6 labs. Proficiency testing was carried out with blinded samples. Statistical analyses were performed for analysis completion, specimen types, testing methodology, mutation findings and clinical variables. Results: Five methodologies (SNaPshot®, mass spectrometry, Sanger +/- PNA, sizing) were variably employed for detection of mutations, with analytic sensitivities of ~5% allele frequency. All sites passed proficiency testing. 1006 specimens had at least one mutation analysis completed, 733 specimens had full genotyping results. Mutat...