miRview Squamous differentiates squamous from nonsquamous NSCLC patients.

Rosetta Genomics reports the commercial availability of its first diagnostic test, miRview™ squamous. The test is being provided through the company’s CLIA-certified lab in Philadelphia.

“miRview squamous is designed to offer a quantitative, objective, and standardized diagnostic tool for differentiating squamous from nonsquamous NSCLC patients,” explains Dalia Cohen, Ph.D., CSO. Based on test results, physicians can decide the best targeted therapy. The test measures the expression level of a miRNA squamous biomarker to differentiate between these two sets of patients.

The test has a reported sensitivity of 97% and a specificity of 91% in identifying squamous cell lung cancer. In blinded tests of lab-to-lab concordance, two labs reached the same classification in over 95% of classified samples, the firm adds. Classification accuracy was measured in a blinded test of a validation set of 64 samples compared to the consensus diagnosis of at least two pathologists, Rosetta Genomics points out.

Current methods for differentiating squamous from nonsquamous non-small-cell lung cancer lack standardization, are difficult to reproduce, and have low accuracy, according to Rosetta Genomics. Studies that reviewed the accuracy and reproducibility of histopathological classification of lung cancer found that 30% to 40% of samples had been misclassified, the company reports.

Over the last few years, Rosetta Genomics has been establishing a base for miRNA-based diagnostics. The company has been working to find miRNA biomarkers and has entered a number of licensing arrangements with universities for their miRNA discovering. It has also secured rights to technology needed for diagnostic development and formed partnerships to aid the same. “We have traveled a significant distance from first discovering microRNA sequences, through the development of our proprietary detection and quantification technologies, to having our first commercially available microRNA-based test,” points out Dr. Cohen.

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