miRview™ squamous utilizes proprietary technology developed by Rosetta Genomics. This technology includes protocols for the extraction of microRNA from formalin-fixed paraffin-embedded (FFPE) tissue samples and quantification of the relative amount of a single squamous microRNA biomarker using quantitative real-time polymerase chain reaction (qRT-PCR) technology to differentiate patients with squamous NSCLC from those with nonsquamous NSCLC.

miRview™ squamous is the product of 2 years of research with hundreds of tumor samples. In the first phase of development, more than 100 tumor samples were studied by high-throughput molecular profiling.¹ Molecular profiling using microRNA microarrays was used to identify the molecular markers differentiating between squamous and nonsquamous NSCLC. In the second phase, the microRNA marker was validated and a diagnostic assay was defined using sensitive and specific proprietary qRT-PCR technology. The accuracy of miRview™ squamous was demonstrated in 2 independent studies.^2,3 The sensitivity and specificity of miRview™ squamous assay were initially determined to be 97% and 91%, respectively, in an independent, blinded test.² In a recent post-approval validation study, the sensitivity and specificity of the miRview™ squamous assay were shown to be 100% and 100%, respectively.³

Although many current cancer tests are largely qualitative and subjective, the measurement of microRNA expression levels in tissue samples offers a quantitative, objective diagnosis. Proprietary technologies enable microRNA profiling with high sensitivity and specificity (as demonstrated by a post-approval validation study for miRview™ squamous, these values have been shown to be 100% and 100%, respectively).³ In addition, microRNAs are stable markers in many body fluids and tissue samples, making them an ideal platform for molecular diagnostics.

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1. Rosenfeld N, Aharonov R, Meiri E, et al. MicroRNAs accurately identify cancer tissue origin. Nat Biotechnol. 2008;26(4):462-469.
2. Lebanony D, Benjamin H, Gilad S, et al.  Diagnostic assay based on hsa-miR-205 expression distinguishes squamous from nonsquamous non-small-cell lung carcinoma. J Clin Oncol. 2009;27(12):2030-2037.
3. Bishop JA, Benjamin H, Cholakh H, Chajat A, Clark DP, Westra WH. Accurate classification of non–small cell lung carcinoma using a novel microRNA-based approach. Clin Cancer Res. 2010;16(2):610-619.