|[June 27, 2013]
Diaxonhit Agrees to Commercialize in Europe the XDx AlloMap® Heart Transplant Test Following the Completion of Exclusive License Agreement
PARIS & BRISBANE, Calif. --(Business Wire)--
Diaxonhit, the leading French provider of specialty diagnostic
solutions, and XDx, Inc., a U.S. molecular diagnostics company focused
on non-invasive tests for transplantation and autoimmune disease, today
announced that they have entered into a definitive exclusive license and
distribution agreement to market and perform AlloMap Molecular
Expression Testing (AlloMap®) in Europe.
Diaxonhit shareholders approved the issuance of warrants and stock to
XDx during the annual meeting held on June 20, 2013, thereby clearing
the final step for the license agreement to become effective.
Diaxonhit will promote AlloMap in Europe through its wholly owned
subsidiary, InGen, the leader in France for marketing tests related to
transplantation and histocompatibility testing.
For the European market, the AlloMap test will be performed centrally in
the "Jean Dausset" Laboratory, a reference laboratory headed by
Professor Dominique Charron, MD, PhD, a leading scientist in the field
of histocompatibility and immunogenetics. This laboratory is part of the
Paris Hospital Group (Assistance Publique - H�pitaux de Paris, AP-HP)
and located within the Saint-Louis Hospital in downtown Paris, France.
All blood samples drawn from European heart transplant recipients will
be shipped to the Jean Dausset Laboratory, where the AlloMap test will
be performed. The laboratory will provide test results to the treating
The test should be available to European patients in selected countries
starting in early 2014.
AlloMap is XDx's flagship gene-expression profiling based blood test.
The test is a new method for regular and non-invasive surveillance of
heart transplant recipients for acute cellular rejection, thereby
contributing to patient follow-up optimization. AlloMap provides unique
information regarding the body's immune response to a transplanted heart
in the form of an objective score.
The test has been validated in four major clinical studies in the US and
Europe, involving over 2,000 heart transplant recipients and 40 clinical
centers. Surveillance of heart recipients with the non-invasive AlloMap
test has been shown to be as effective as surveillance with biopsies in
heart transplantation clinical outcomes, based on the landmark IMAGE
study published in the New England Journal of Medicine in April 2010.
The International Society of Heart and Lung Transplantation recommended
AlloMap testing in its guidelines for the management of heart transplant
recipients in August 2010.
XDx initiated commercial AlloMap testing in the US in 2005 as a
Laboratory Developed Test (LDT). In 2008 the test was FDA cleared
through the 510K de novo process. It received CE marking in 2011.
To date, over 45,000 AlloMap commercial tests have been performed in
more than 11,000 patients in 100 transplant centers in the US. There are
approximately 2,000 heart transplantations performed annually in each of
the US and European territories, with over 20,000 living heart
transplant recipients in both the US and Europe. In Europe, five
countries (France, Germany, Italy, Spain, and UK) constitute 70% of
these transplants, half of which are conducted in 25 major hospitals(1).
AlloMap is priced in the same range as other high-value multivariate
molecular diagnostic assays. Approximately 85% of the tests performed in
US patients are currently reimbursed by a combination of private and
The "Jean Dausset" Laboratory for Histocompatibility and
Originally known as the Regional Laboratory for Histocompatibility, the
laboratory was founded in 1975 by Professor Jean Dausset, 1980
Nobel (News - Alert) Laureate in Medicine for the discovery of the HLA system. Since
1991, it is headed by Professor Dominique Charron and is EFI (European
Federation for Immunogenetics) accredited since 1997.
The Dausset Laboratory is the largest HI (Histocompatibility -
Immunogenetics) Laboratory in Europe, in charge of pre and post
transplantation HI monitoring of approximately 1,625 organ-transplanted
patients representing 40% of the French national organ transplants. Its
activities include histocompatibility testing for organ transplantation,
biobanking, research and quality insurance.
(1) Source (News - Alert) : French Biomedicine Agency
Diaxonhit (NYSE Alternext, FR0004054427, ALEHT) is a French fully
integrated leader in the in-vitro diagnostic field, involved from
research to commercialization of specialty diagnostic products.
With many partnerships and a strong presence in hospitals, Diaxonhit has
an extensive commercialization network. Through its affiliate, InGen, it
commercializes and services, mostly under exclusivity agreements,
in-vitro diagnostic kits and advanced equipment. It operates mainly in
the fields of transplantation, infectious diseases and autoimmunity,
product quality control and rapid tests, including Tetanus Quick Stick®,
a proprietary product. InGen is the leading supplier in France of HLA
tests manufactured by Thermo-Fisher/One Lambda, of which it is the
largest distributor worldwide.
The group also owns a diversified portfolio of products in development,
including both innovative molecular and non-molecular diagnostics,
covering three main specialty areas: immuno-infection, Alzheimer's
disease and cancer.
Diaxonhit headquarters are located in Paris and its affiliate in the
Paris region. The Group is listed on NYSE Alternext in Paris and is part
of the NYSE Alternext OSEO innovation index.
For more information, please visit: http://www.diaxonhit.com.
XDx Inc., based in Brisbane, California, is a molecular diagnostics
company focused on the discovery, development and commercialization of
clinically differentiated, high value, non-invasive tests to monitor
immune status in transplant recipients and autoimmune disease and
potentially improve long-term patient outcomes. The company has
commercialized AlloMap Molecular Expression Testing (AlloMap®), which
aids physicians in determining the low risk of acute cellular rejection
at the time of testing in stable post-cardiac transplant patients. Some
of the AlloMap technology developed by XDx may be applicable to other
conditions that involve transplant rejection and diseases that affect
the immune system. XDx also has an active diagnostic development program
in system lupus erythematosus, which includes several potential tests to
address the high unmet medical need in managing this chronic disease.
For more information, please visit: www.xdx.com.
AlloMap Molecular Expression Testing is a non-invasive gene expression
test used to aid in the identification of heart transplant recipients
with stable allograft function who have a low probability of
moderate/severe acute cellular rejection at the time of testing in
conjunction with standard clinical assessment. AlloMap testing measures
the expression levels of 20 genes from a blood sample. The combined
expression of these genes is represented as an AlloMap test score.
AlloMap is performed in XDx's CLIA and CAP certified laboratory and has
been commercially available in the United States since 2005. In 2008 the
US Food and Drug Administration cleared AlloMap which was also CE marked
in the European Union in 2011. Use of AlloMap is included in the
International Society for Heart and Lung Transplantation (ISHLT)
Practice Guidelines, published in August 2010, the worldwide standard
for the care of heart transplant patients.
This press release contains elements that are not historical facts
including, without limitation, certain statements about future
expectations and other forward-looking statements. Such statements are
based on management's current views and assumptions and involve known
and unknown risks and uncertainties that could cause actual results,
performance or events to differ materially from those anticipated.
In addition, Exonhit, its shareholders, and its affiliates,
directors, officers, advisors and employees have not verified the
accuracy of, and make no representations or warranties in relation to,
statistical data or predictions contained in this press release that
were taken or derived from third party sources or industry publications,
and such statistical data and predictions are used in this press release
for information purposes only.
Finally, this press release may be drafted in the French and English
languages. In an event of differences between the texts, the French
language version shall prevail.
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