Rosetta Genomics a leading developer and provider of microRNA-based molecular diagnostic tests, announces it has entered into a collaboration with the University of California, Davis (UC Davis or the University) to develop and validate a microRNA profile for Muscle-Invasive Bladder Cancer (MI-BC) that is predictive of patient response to neoadjuvant chemotherapy. The collaboration allows for UC Davis researchers to continue using Rosetta's platforms and microRNAs to further discover new biomarkers and validate their results.

Researchers have initiated collaborations by studying 55 MI-BC patients treated at UC Davis Cancer Centre with neoadjuvant chemotherapy. The primary goal of this study is to develop and validate a microRNA profile of MI-BC that is predictive of patient response to neoadjuvant chemotherapy. A secondary goal of the study is to understand the mechanism by which differentially expressed microRNAs mediate chemosensitivity.

Approximately 30 percent of bladder cancer patients present with or will develop MI-BC, which has a five-year survival rate of approximately 50 percent. Evidence-based medicine has clearly demonstrated the survival benefit of neoadjuvant chemotherapy (i.e., methotrexate, vinblastine, doxorubicin, and cisplatin) for the treatment of this disease. However, only 50 percent of patients with MI-BC will respond to chemotherapy, which discourages widespread adoption. Instead of chemotherapy many of these patients are offered cystectomy (removal of bladder), a treatment option that has failed to improve survival rates meaningfully over the past 25 years.

Ralph W deVere White, MD, director, UC Davis Cancer Centre, Associate Dean for Cancer Programmes, Distinguished Professor, Department of Urology Codman-Radke Chair in Cancer Research, commented on the research collaboration he is leading, saying, “We are delighted to be working with the Rosetta Genomics' microRNA platforms as they represent robust and potentially powerful biomarkers. We look forward to the opportunity to validate a microRNA biomarker that would predict the response among patients with bladder cancer to neoadjuvant chemotherapy, as the ability to predict which MI-BC patients will respond to such treatment will increase survival rates while minimizing unnecessary expense and exposure to treatment-associated toxicities.”

Kenneth A Berlin, president and chief executive officer of Rosetta Genomics, said, “Predicting responses to chemotherapy is becoming increasingly important with advances in oncology and the introduction of molecularly targeted cancer drugs. We are delighted to be collaborating with UCD researchers to demonstrate the valuable role our microRNA biomarkers may play in patient selection. We look forward to continuing our work with UC Davis researchers as deeper understanding of the mechanisms that promote MI-BC progression and predict response to chemotherapy is also critical for improvement in survival rate as it will allow for the development of new treatment strategies.”

miRview are a series of microRNA-based diagnostic products offered by Rosetta Genomics. miRview mets and miRview mets2 accurately identify the primary tumor site in metastatic cancer and CUP. miRview squamous accurately identifies the squamous subtype of non-small cell lung cancer, which carries an increased risk of severe or fatal internal bleeding and poor response to treatment for certain therapies. miRview meso diagnoses mesothelioma, a cancer connected to asbestos exposure. miRview tests are designed to provide objective diagnostic data; it is the treating physician's responsibility to diagnose and administer the appropriate treatment.

microRNAs (miRNAs) are recently discovered, small RNAs that act as master regulators of protein synthesis, and have been shown to be highly effective biomarkers. The unique advantage of microRNAs as biomarkers lies in their high tissue specificity, and their exceptional stability in the most routine preservation methods for biopsies, including Formalin Fixed Paraffin Embedded (FFPE) block tissue and Fine Needle Aspirate (FNA) cell blocks. It has been suggested that their small size (19 to 21 nucleotides) enables them to remain intact in FFPE blocks, as opposed to messenger RNA (mRNA), which tends to degrade rapidly. In addition, early preclinical data has shown that by controlling the levels of specific microRNAs, cancer cell growth may be reduced.

Rosetta Genomics develops and commercializes a full range of microRNA-based molecular diagnostics.

UC Davis Cancer Centre is the only National Cancer Institute-designated centre serving the Central Valley and inland Northern California, a region of more than 6 million people. Through the Cancer Care Network, UC Davis is collaborating with a number of hospitals and clinical centres throughout the Central Valley and Northern California area to offer the latest cancer care services.