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"The initiation of this validation study is an integral part of thecommercialization roadmap for our diagnostic tests, as we advance themtowards use in a clinical setting," said Amir Avniel, President and CEO ofRosetta Genomics. "We believe the initiation of this study for our CUP assaywith a leading cancer research center such as M. D. Anderson attests to thecritical unmet need this test addresses." CUP is a heterogeneous group ofcancers that constitutes 3-5% of all cancers with a poor median survival of6-10 months(1). Each year, approximately 70,000 patients in the United Statesare diagnosed with CUP. A patient is typically diagnosed with CUP only afterundergoing a wide range of tests, including various imaging tests such asx-ray, CT, MRI, and PET, which often fail to identify the origin of thecancer.
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Presently, the choice of treatment for metastatic cancer is largelydependent on the nature of the primary tumor. Patients with CUP pose atherapeutic dilemma and treatment is often empiric with a "trial and error"approach. In the era of rapidly growing effective cytotoxic and targetedtherapies for known cancers, quicker and more accurate methods of identifyingthe tissue of origin of CUP cases would permit the use of these therapies,thereby improving the chances of achieving a response and possibly extendingthe patient's survival.
"The current gold standard diagnostic evaluation for CUP consists of acareful history and physical examination, laboratory tests, imaging studies,invasive studies when necessary, and thorough pathologic evaluation. Thisprocess is lengthy and exposes the patient to unnecessary toxicities," notedDr. Gauri Varadhachary (M.D. Anderson - Please insert title). "RosettaGenomics' microRNA-based CUP assay may present an alternative test to currentdiagnostic practices. This study aims to validate their assay as well ascompare its performance with current tests for CUP."
About microRNAs
MicroRNAs (miRNAs) are recently discovered, naturally occurring, smallRNAs that act as master regulators and have the potential to form the basisfor a new class of diagnostics and therapeutics. Since many diseases arecaused by the abnormal activity of proteins, the ability to selectivelyregulate protein activity through microRNAs could provide the means to treata wide range of human diseases. In addition, microRNAs have been shown tohave different expression in various pathological conditions. As a result,these differences may provide for a novel diagnostic strategy for manydiseases.
About Rosetta Genomics
Rosetta Genomics (Nasdaq: ROSG) is a leader in the field of microRNAs.Founded in 2000, the company's integrative research platform combiningbioinformatics and state-of-the-art laboratory processes has led to thediscovery of hundreds of biologically validated novel human microRNAs.Building on its strong IP position and proprietary platform technologies,Rosetta Genomics is working on the application of these technologies in thedevelopment of a full range of microRNA-based diagnostic and therapeutictools, focusing primarily on cancer and various women's health indications.The first microRNA diagnostic test applying Rosetta Genomics' technology hasbeen approved for clinical us
