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Why Rosetta Genomics, Ltd. (ROSG) is the Leader in MicroRNA-Based Cancer Testing Services
Rosetta Genomics has developed a suite of microRNA-based diagnostics that were discovered through the company’s proprietary microRNAs and platform technologies. These technologies have made considerable headway in the medical field, demonstrating how microRNAs have the potential to accurately diagnose and classify cancer, as well as to identify the origin of metastases, or where the cancer originated in the body.
Founded in 2000, Rosetta can be credited with building the field of microRNAs, and was one of the first to demonstrate that serum microRNAs can be novel biomarkers, which are molecular “flags” indicative of a biological state or condition. Thus far, the company has discovered more than 300 biologically validated novel human microRNAs.
This discovery is significant, considering that microRNAs have already demonstrated potential to revolutionize cancer diagnostics. The company has also identified microRNAs’ central role to a host of other conditions, including autoimmune and inflammatory diseases, cardiovascular diseases, diabetes and obesity, infectious diseases, and neurological disorders.
Rosetta’s technologies are packed into an intellectual property portfolio that currently consists of 33 issued patents, two allowed patents, and 46 patent applications. Building on this strong patent position and proprietary platform technologies, Rosetta is working to apply these technologies in the development and commercialization of a full range of microRNA-based diagnostic tools.
Rosetta currently has four revenue-generating microRNA-based diagnostic tests targeting: cancer origin; lung cancer; kidney cancer; and mesothelioma, a form of cancer most commonly found in the chest and abdomen, generally connected to asbestos exposure.
• The Rosetta Cancer Origin Test™ accurately identifies the primary tumor type in primary and metastatic cancer by measuring the expression levels of 64 microRNAs, which are then processed through the company’s proprietary algorithm. The test results can accurately identify the origin of the patients’ tumor for 49 cancer origins with 85% sensitivity and 99% specificity. By determining cancer origin, clinicians can better diagnose patients and determine optimal treatment options.
• The Rosetta Lung Cancer Test™ accurately identifies the four main subtypes of lung cancer: squamous Non-Small Cell Lung Cancer (NSCLC), non-squamous NSCLC, Small Cell Lung Cancer or carcinoid. The test is based on the expression level of eight microRNAs extracted via cytological procedures such as fine-needle aspiration (FNA), bronchial brushing and washing, and biopsy sample.
• The Rosetta Kidney Cancer Test™ uses 24 microRNAs to accurately classify the four most common kidney tumors: Clear cell RCC, Papillary RCC, Chromophobe RCC, and benign Oncocytoma. A validation set of 201 independent samples was classified using the test and analyzed blindly. The test produced results for 92% of the samples with an accuracy of 95%.
• The Rosetta Mesothelioma Test™ leverages the high specificity of microRNAs as biomarkers to differentiate mesothelioma, a malignant tumor connected to asbestos exposure, from carcinomas in the lung and pleura, a medically and legally important differential diagnosis. Distinguishing between the two conditions is vital, and allows for specific and treatment regimens for each condition. Currently there is no other single diagnostic test that is conclusive for this differentiation.
Cancer obviously isn’t constrained by geological boundaries, and to capture its portion of the global diagnostics market Rosetta offers its four commercial-stage oncology tests in multiple countries around the world; implemented a global comprehensive sales and marketing effort for its cancer origin test; obtained Medicare and private pay coverage for the origin test; initiated a master service provider agreement with a global biopharmaceutical company; and plans to execute collaboration deals with additional pharma/biotech and Dx companies.
In 2013, Rosetta raised more than $3 million in financing and at year-end reported more than $20 million in cash, which the company says is enough to fund operations well into 2015. Furthermore, the company has no debt.
These factors position Rosetta with room to leverage microRNAs as stable, sensitive, and specific markers, and to advance and develop multiple diagnostic programs in cancer and for various other indications to enable accurate diagnosis and targeted treatment. The company’s current product pipeline consists of programs in various stages of development and/or marketing: thyroid neoplasia, the company’s lead product with launch expected in 205; bladder, ovarian and breast cancers; heart failure, kidney rejection; Alzheimer’s disease; and cytomegalovirus (CMV) therapeutics.
For more information visit www.rosettagenomics.com
