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TcLand Expression Launches An International, Multicenter Clinical Validation Study


10/13/2009 1:54:09 PM

Nantes, France, October 13, 2009 - TcLand Expression SA, a global leader in the field of gene expression biomarkers in immunology, today announced the launch of the KARE study (Kidney Allograft REjection). This will be the international, multicentre, prospective clinical validation study for TcLand Expression’s K-RejX qPCR blood test, as a multi-gene molecular diagnostic tool to help in the identification of kidney transplant recipients at risk of chronic antibody-mediated rejection (CAMR). The KARE study will enroll 450 patients from over 30 European and North American large transplantation centers.

"The K-RejX diagnostic blood test will be a great step forward in the management of CAMR, this form of late-onset kidney transplant rejection. It will address some of the limitations of graft biopsies (notably by precluding non-contributive biopsies), as well as of the detection of circulating DSA and will also have a positive impact on the healthcare system in terms of overall cost efficiency and quality of care", commented Patrick Larcier, PharmD, TcLand Expression's Vice-President of Regulatory and Clinical Affairs.

K-RejX is a non-invasive, gene expression diagnostic blood test that has been designed to be performed as a Laboratory Designed Test (LDT) solely in TcLand Expression's ISO 17025-accredited laboratory in Nantes, France. The KARE study will meet the most stringent regulatory requirements for complex & high-value diagnostic and TcLand Expression expects to launch the K-RejX test by 2011.

Early prediction of the long-term post-transplantation prognosis is a major issue, since it enables therapy to be adapted to match the risk of graft rejection in a given recipient. The K-RejX test's ease of use is positioning it as a diagnostic blood test that should be systematically performed for monitoring patients more accurately and more frequently and thus improving the overall management of the transplant recipient.

Transplantation1

Today, more than 350,000 patients live with a transplanted organ and more than 150,000 are on a transplantation waiting list. Given that early diagnostic of a graft rejection enables rapid and effective patient management and the avoidance of graft rejection, improving transplantation outcomes (i.e. increasing the graft's lifetime and diminishing the morbimortality due to chronic exposure to immunosuppressants) is a major challenge in public health.

TcLand Expression's biomarker programs

With the KARE Study, TcLand Expression has two gene expression biomarkers in transplantation, KRejX (in kidney) and L-TolX (in liver) currently in late-stage clinical validation. The L-TolX blood test is also a multigene molecular diagnostic tool for helping identify liver transplant recipients with stable allograft function for whom immunosuppression withdrawal is being considered. The L-TolX blood test started its international, multicentre, clinical validation phase in September 2007.

The Frost & Sullivan awards

On October 8th, TcLand Expression received 2 prestigious awards at the Frost & Sullivan Excellence in Healthcare Awards event in London:

• the “Entrepreneurial Company of the Year Award 2009” in recognition of TcLand Expression's biomarker discovery and development work

• the “Technology Innovation Award”, validating the company's gene expression biomarker platform.

About TcLand Expression SA

TcLand Expression SA is a recognized pioneer in the discovery, monitoring and interpretation of gene expression biomarkers for unmet medical needs in transplantation and auto-immune disease. The company benefits from an exceptional scientific and clinical environment. For more information, please visit our website www.tcland-expression.com/

About Frost & Sullivan Best Practices Awards

Frost & Sullivan Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research in order to identify best practices in the industry.


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