Under the terms of the agreement, Rosetta will partially fund the research and receive an exclusive worldwide license to the technology, including the right to sublicense the technology. The project is initially planned for a two-year period. Joint patents will be co-owned by Rosetta and Mor, a private corporation incorporated in Israel that is Clalit Health Management Organization's technology transfer company.
Prof. Eytan Mor, Director of the Department of Organ Transplantation, Rabin Medical Center, is the Principal Investigator of the upcoming proof of concept (POC) study to identify a microRNA signature for CAD in blood and/or urine and to assess the feasibility of developing a microRNA-based assay for the non-invasive diagnosis of CAD.
Chronic rejection is currently diagnosed only by histological examination of a tissue sample obtained by biopsy, which is expensive, unpleasant for the patient and unsuitable for serial clinical use due to the risk of bleeding and other complications. Furthermore, morphological changes may be patchy, difficult to interpret and subject to observer bias. Therefore, it is widely accepted that measurement of chronic graft injury is imprecise.
"Despite an improvement in kidney transplant survival in the early post-transplantation stage, there still remains the need for a sensitive, etiology-specific and non-invasive method for monitoring the function of the renal allograft in the late post-transplantation period, where chronic rejection is an almost universal finding," noted Dr.. Alexander Yussim, a leading transplant immunology researcher from Beilinson's transplant department. "The non-invasive test we would like to develop could have potential to enable diagnosis at an earlier stage when this information could alter the choice of therapy and, ultimately, improve outcomes."
"This collaboration provides Rosetta with the opportunity to combine our leading microRNA biomarker technology platform with the expertise of leading organ transplant experts to identify clinically meaningful biomarkers to assess the possibility of developing a non-invasive diagnostic that could provide transplant experts with important information that could help guide their treatment choices to the benefit of their patients," stated Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. "Following successful results in the POC study, we intend to move forward toward the development and validation of a possible selected microRNA signature. We believe this targeted audience of transplant clinicians can be reached with a small, dedicated commercial team and we aim to launch the product in 2017."