Rosetta Genomics Ltd. announced that the company has entered into a research agreement with Sheba Medical Center to develop a microRNA-based signature to predict response to Nivolumab, an immunotherapy drug marketed as Opdivo®, which is approved for the treatment of lung cancer patients. The prospective study, 'Circulating microRNA Biomarkers for Lung Cancer Patient Response to the Drug Nivolumab when Administered as Second Line', will be led by Jair Bar, M.D., Deputy Director-Institute of Oncology, Sheba Medical Center, and will include collection of whole blood, peripheral blood mononuclear cells (PBMCs) and serum samples. Rosetta will use its proprietary microarray design and qRT-PCR platform to identify miRNAs associated with response. The primary endpoint of the study is prediction of Objective Response Rate (ORR) as measured by tumor radiologic response to the immunotherapy (RECIST 1.1 response rate at 6 months.) The secondary endpoint of the project is to predict survival benefit of advanced non-small cell lung cancer (NSCLC) from immunotherapy as measured by Overall Survival (OS) and OS rate (12 and 24 months). microRNAs are key regulators of immune system and have been shown to directly target and inhibit PD-1 and PDL-1 in various cancers. Their important biological role as well as high stability in the circulation makes them excellent candidates for predicting response to these breakthrough drugs. The development of a new microRNA biomarker signature to predict response to Opdivo in lung cancer patients fits well with comprehensive lung-specific menu that assists in diagnosis, prognosis, and prediction to therapy for lung cancer patients. This menu includes a full array of lung-specific biomarkers via FISH, PCR, and IHC, OncoGxLung (utilizing NGS), and mi-LUNG, a proprietary microRNA diagnostic test for differentiating between the 4 main subtypes of lung cancer.