Detection of EML4-ALK in serum RNA from lung cancer patients

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The presence of the transforming fusion gene EML4-ALK in non–small cell lung cancer (NSCLC) is a predictive marker for the efficacy of ALK kinase inhibitors. Circulating RNA in serum is an emerging field for noninvasive molecular diagnosis. We designed EML4-ALK detection assay using PCR-based MassARRAY platform. We attempted a RNA extraction method, primer design, and reverse transcription reagents to optimize our detection system with serum samples. We evaluated whether EML4-ALK fusion RNA could be detected in serum obtained from 12 NSCLC patients with ALK rearrangements. The EML4-ALK RNA (variant 1 and 3) was detected in serum from 2 of 12 patients. The detection of EML4-ALK in serum RNA samples by MassARRAY assay is feasible. This noninvasive assay will be useful in patients with insufficient or unavailable tumor specimens. Additional experiments will reveal the sensitivity and specificity of this detection system.