Rosetta Genomics Enters Collaboration With Clalit Health Services' Rabin Medical Center for microRNA-Based Assay for Chronic ...
March 24 2014 - 9:15AM
Marketwired
Rosetta Genomics Enters Collaboration With Clalit Health Services'
Rabin Medical Center for microRNA-Based Assay for Chronic Allograft
Dysfunction Following Kidney Transplantation
Combines Rabin's Expertise in Transplantation With Rosetta's
World Class microRNA Biomarker Platform
PRINCETON, NJ and REHOVOT, ISRAEL and PETAH TIKVAH,
ISRAEL--(Marketwired - Mar 24, 2014) - Rosetta Genomics Ltd.
(NASDAQ: ROSG), a leading developer and provider of microRNA-based
molecular diagnostics, reports that the Company has entered a joint
collaboration with Clalit Health Services' Rabin Medical
Center-Beilinson Campus (Petah Tikvah, Israel), a non-profit
corporation, for the development of a non-invasive, microRNA-based,
assay for the diagnosis of chronic allograft dysfunction (CAD or
chronic rejection) following kidney transplantation.
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."
About Chronic Allograft Dysfunction Kidney transplantation is
widely accepted as the treatment of choice for end-stage renal
disease. The number of patients receiving renal replacement therapy
worldwide is estimated at more than 1.4 million and is growing by
approximately 8% annually. Advances in post-transplant care
including the introduction of new potent immunosuppressive drugs
have led to a dramatic decrease in acute kidney rejection. However,
long-term stable graft function remains elusive, and in the past
decade, progressive chronic deterioration, or chronic rejection,
and the resulting inevitable graft loss has become a major problem
in organ transplantation.
The incidence of rejection is high, at a rate of 30% of all
grafts in the first post-transplant year, progressing to 50% in
year five and reaching nearly 100% of functioning grafts 10 years
after transplantation.
About Rosetta Cancer Testing Services Rosetta Cancer Tests are a
series of microRNA-based diagnostic testing services offered by
Rosetta Genomics. The Rosetta Cancer Origin Test™ can accurately
identify the primary tumor type in primary and metastatic cancer
including cancer of unknown or uncertain primary (CUP). Rosetta
Mesothelioma Test™ diagnoses mesothelioma, a cancer connected to
asbestos exposure. The Rosetta Lung Cancer Test™ accurately
identifies the four main subtypes of lung cancer using small
amounts of tumor cells. The Rosetta Kidney Cancer Test™ accurately
classifies the four most common kidney tumors: clear cell renal
cell carcinoma (RCC), papillary RCC, chromophobe RCC and
oncocytoma. Rosetta's assays are designed to provide objective
diagnostic data; it is the treating physician's responsibility to
diagnose and administer the appropriate treatment. In the U.S.
alone, Rosetta Genomics estimates that 200,000 patients a year may
benefit from the Rosetta Cancer Origin Test™, 60,000 from the
Rosetta Mesothelioma Test™, 65,000 from the Rosetta Kidney Cancer
Test™ and 226,000 patients from the Rosetta Lung Cancer Test™. The
Company's assays are offered directly by Rosetta Genomics in the
U.S., and through distributors around the world. For more
information, please visit www.rosettagenomics.com. Parties
interested in ordering the test can contact Rosetta Genomics at
(215) 382-9000 ext. 309.
About Rosetta Genomics Rosetta develops and commercializes a
full range of microRNA-based molecular diagnostics. Founded in
2000, Rosetta's integrative research platform combining
bioinformatics and state-of-the-art laboratory processes has led to
the discovery of hundreds of biologically validated novel human
microRNAs. Building on its strong patent position and proprietary
platform technologies, Rosetta is working on the application of
these technologies in the development and commercialization of a
full range of microRNA-based diagnostic tools. Rosetta's cancer
testing services are commercially available through its
Philadelphia-based CAP-accredited, CLIA-certified lab.
Forward-Looking Statement Disclaimer Various statements in this
release concerning Rosetta's future expectations, plans and
prospects, including, but not limited to the possibility that the
study will identify a microRNA signature for CAD and that the study
will successfully assess the feasibility of developing a
microRNA-based assay for the non-invasive diagnosis of CAD, and
that the POC study will be successful, as well as that Rosetta will
develop and validate a non invasive assay that could provide
transplant experts with important information that could help guide
their treatment choices to the benefit of their patients constitute
forward-looking statements for the purposes of the safe harbor
provisions under The Private Securities Litigation Reform Act of
1995. Actual results may differ materially from those indicated by
these forward-looking statements as a result of various important
factors, including those risks more fully discussed in the "Risk
Factors" section of Rosetta's Annual Report on Form 20-F for the
year ended December 31, 2012 as filed with the SEC. In addition,
any forward-looking statements represent Rosetta's views only as of
the date of this release and should not be relied upon as
representing its views as of any subsequent date. Rosetta does not
assume any obligation to update any forward-looking statements
unless required by law.
Company Contact: Rosetta Genomics Ken Berlin President & CEO
(609) 419-9003 investors@rosettagenomics.com Investor Contacts: LHA
Anne Marie Fields (212) 838-3777 afields@lhai.com or Bruce Voss
(310) 691-7100 bvoss@lhai.com
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