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Rosetta Genomics, Israeli Medical Center to Develop miRNA Assay for CAD

NEW YORK (GenomeWeb News) — Rosetta Genomics said today that it is collaborating with Clalit Health Services' Rabin Medical Center-Beilinson Campus to develop a non-invasive, microRNA-based assay to diagnose chronic allograft dysfunction (CAD) following kidney transplantation.

Under the agreement, Rosetta will partially fund the research and receive an exclusive worldwide license to the technology, including sublicensing rights. Rosetta and Mor, a private Israeli corporation that acts as Clalit Health Management Organization's tech-transfer company, will co-own joint patents that arise from the project.

The project is initially planned for a two-year period. Eytan Mor, director of the department of organ transplantation at Rabin Medical Center, is the principal investigator in an upcoming proof-of-concept study to identify a miRNA signature for CAD, also called chronic rejection, in blood and/or urine. The study also will evaluate the feasibility of developing an miRNA assay for the non-invasive diagnosis of CAD.

Rosetta President and CEO Kenneth Berlin said that if the study is successful, the company will develop and validate the selected miRNA signature with plans to launch a product in 2017.

CAD 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, Rosetta said. Furthermore, morphological changes may be patchy, difficult to interpret, and subject to observer bias.

"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," Alexander Yussim, a transplant immunology researcher from Beilinson's transplant department, said in a statement.