Healthcare Industry News:  Molecular Expression Testing 

Diagnostics Venture Capital

 News Release - August 5, 2009

XDx Completes $14.4 Million Series G Financing

XDx Poised to Achieve Break-Even in 2010

BRISBANE, Calif.--(HSMN NewsFeed)--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.

Source: XDx

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