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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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