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XDx Completes $14.4 Million Series G
Financing XDx Poised to Achieve Break-Even in 2010
BRISBANE, CA, August 5, 2009 – XDx, Inc., a molecular
diagnostics company focused on noninvasive gene expression tests
for the monitoring of immune-mediated conditions, today
announced the completion of a Series G financing, in which the
company raised approximately $14.4 million. The round was led by
Bristol-Myers Squibb Company (BMS) (NYSE: BMY), with additional
participation from all active previous investors in XDx,
including: Burrill Venture Capital; Duff, Ackerman & Goodrich;
Integral Capital Partners; Intel Capital; Kleiner Perkins
Caulfield & Byers; Sprout Group (whose healthcare technology
investments are managed by New Leaf Venture Partners); and TPG
Biotechnology. Proceeds from this financing will be used to
support commercial activities associated with the company’s
AlloMap® Molecular Expression Testing and to advance ongoing and
new research and development programs.
"The continued interest and support XDx has received from the
venture capital community and now big pharma is a testament to
its leadership in molecular diagnostics and personalized
medicine," stated Brook H. Byers, partner at Kleiner Perkins
Caulfield & Byers, and chairman of the Board of Directors for
XDx. "While the overall biotechnology financing environment
continues to be challenging, XDx stands out due to the market
success of AlloMap and its positive impact on the clinical
management of heart transplant recipients. This round also
underscores our confidence in the significant potential for the
company’s gene expression testing to expand into other areas of
transplant medicine, as well as autoimmune diseases."
Jeremy Levin, M.D., Ph.D., senior vice president, Strategic
Transactions Group at Bristol-Myers Squibb, said, "We are very
pleased with our ongoing collaboration with XDx which aims to
identify biomarkers of Systemic Lupus Erythematosus (SLE). We
are delighted to continue to support the innovative work of XDx
in the important field of noninvasive molecular diagnostics.
Bristol-Myers Squibb has a commitment to help drive innovation
in the field of biomarkers and personalized medicine with the
hope and expectation that these efforts will help develop
therapeutics better targeted to cure disease."
"This financing is important to achieving our business
objectives and aligning the organization for long-term success,
and we appreciate the continued support of our investors and
strategic partner, BMS," commented Pierre Cassigneul, president
and chief executive officer of XDx. "We continue to focus on
achieving break-even status during 2010 and expanding the market
for AlloMap."
In August 2008, XDx announced that it received market clearance
from the U.S. Food and Drug Administration (FDA) for AlloMap
Molecular Expression Testing. The AlloMap Test is an In Vitro
Diagnostic Multivariate Index Assay (IVDMIA) test service,
performed in a single laboratory, assessing the gene expression
profile of RNA isolated from peripheral blood mononuclear cells
(PBMC). AlloMap testing is intended 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. XDx is the first molecular diagnostics
company to obtain FDA clearance of an IVDMIA for use in
immunology.
XDx is evaluating its gene expression discovery and development
platform for use in other immune-mediated conditions. XDx is
conducting the Systemic Lupus Erythematosus Activity Gene
Expression (SAGE) Study, which follows individuals with a known
diagnosis of SLE for changes in disease activity during the
course of one year. The goal is to develop new blood tests to
help clinicians accurately predict which lupus patients will
flare, when the flares will occur, and the flare severity.
SLE is a systemic, chronic autoimmune disorder that affects more
than 300,000 people in the United States. Clinical management of
patients with SLE is complicated by the recurrence of disease
flares, which can vary in timing and severity and result in
hospitalization, and by disease progression including kidney
failure and damage to other organs.
About XDx
Based in Brisbane, California, XDx is a molecular diagnostics
company focused on the discovery, development and
commercialization of noninvasive gene expression-based tests for
the monitoring of transplant rejection and autoimmune diseases.
The company has developed a proprietary new method for
noninvasively monitoring immune system activity by measuring
gene expression in a patient’s peripheral blood. This work is
the basis for AlloMap® Molecular Expression Testing, which
provides transplant physicians with a new tool to aid in the
identification of the probability of acute cellular rejection
for post-cardiac transplant patient management.
Some of the AlloMap Molecular Expression Technology developed
and implemented by XDx in heart transplant patient management
may be applicable to other diseases that involve transplant
rejection and the immune system. XDx’s noninvasive technology
offers the potential to decrease healthcare costs and
significantly improve the quality of life for patients with a
variety of life-threatening or life-altering immune-mediated
diseases.
In addition to the SAGE Study, XDx has several ongoing studies
focused on AlloMap. The company anticipates results from its
Invasive Monitoring Attenuation through Gene Expression (IMAGE)
trial, a comparative efficacy clinical study designed to
demonstrate the non-inferiority of clinical outcomes of heart
transplant recipients managed with the AlloMap test compared to
endomyocardial biopsy, at the end of 2009 or early 2010.
Contact
Sheryl Seapy, Pure Communications (949) 608-0841 |