Rosetta Genomics has announced that data from a study validating the Company's miRview® lung assay was published in the online edition of the Journal of Molecular Diagnostics in an article titled, "Classification of the Four Main Types of Lung Cancer Using a MicroRNA-Based Diagnostic Assay."
The abstract for this article can be accessed online at http://www.journals.elsevierhealth.com/periodicals/jmdi/article/S1525-1578%2812%2900125-0/abstract?source=aemf.
The miRview® lung assay is based on the expression levels of eight microRNAs, measured using a sensitive quantitative RT-PCR platform.
In this study, the assay was validated on an independent set of 451 samples, more than half of which were preoperative cytologic samples (fine-needle aspirations and bronchial brushings and washings).
More than 90% of the samples were successfully processed with an overall accuracy of 94%. Similar performance was observed in both pathologic and cytologic samples, demonstrating the assays' ability to differentiate between four major types of lung cancer: squamous cell carcinoma, non-squamous non-small cell lung cancer, carcinoid, and small cell carcinoma.
The study noted that, "For patients with primary lung cancer, accurate determination of the tumor type significantly influences treatment decisions. However, techniques and methods for lung cancer typing lack standardization. In particular, owing to limited tumor sample amounts and the poor quality of some samples, the classification of primary lung cancers using small preoperative biopsy specimens presents a diagnostic challenge using current tools."
The study concluded that, "miRview® lung is a simple and reliable diagnostic assay that offers an accurate and standardized classification tool for primary lung cancer using pathologic and cytologic samples."
"We are very pleased to have these positive data on our miRview® lung assay published in this prestigious peer reviewed journal, particularly as it comes on the heels of our recent approval from the New York State Department of Health to test patient samples in the State. Now, miRview® lung is available for testing patient samples in all 50 states," said Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics.
Berlin continued, "The ongoing publication of positive data such as these further validate our microRNA diagnostic assays and platform, and are a testament to the potential of our powerful microRNA technology platform. Importantly, these peer-reviewed articles form the foundation of our scientific- and clinically-based educational and commercial efforts. This study marks the 35th peer-reviewed publication covering our work in the area of microRNAs, which we believe speaks to the robustness and breadth of our microRNA platform.
"New lung cancer treatments that are tumor specific require accurate sub-classification to optimize treatment strategies. Our miRview® lung assay, with its proven ability to differentiate four major sub-types of lung cancer, can provide a simple and reliable tool for clinicians in developing their treatment protocols. The National Cancer Institute estimates that there will be more than 226,000 new cases of lung cancer in the U.S. in 2012 making it the second most common cancer. In addition, as lung cancer is the primary cause of cancer-related death in both men and women in the U.S., we believe the use of this important cancer diagnostic will benefit physicians, patients and payers in efficiently and effectively managing this serious disease," concluded Mr. Berlin.