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CareDx to Present New Data on AlloMap(R) and Cell-Free DNA (cfDNA) Biomarker in Heart Transplant Recipients at ISHLT 2015

BRISBANE, Calif., April 8, 2015 (GLOBE NEWSWIRE) -- CareDx, Inc. (Nasdaq:CDNA), a molecular diagnostics company focused on the development and commercialization of clinically differentiated, high value, non-invasive surveillance solutions for transplant recipients, today announced that new data on its molecular diagnostic surveillance solution AlloMap® and cell-free DNA (cfDNA) will be presented at the 35th Annual Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation (ISHLT) being held April 15-18 in Nice, France.

A total of nine presentations featuring CareDx technology will be highlighted, including new evidence from analyses derived from the CARGO II heart transplant observational study (Cardiac Allograft Rejection Gene expression Observational study II) assessing AlloMap in combination with a cfDNA biomarker in heart transplant recipients. Updates from the OAR Registry (Outcomes AlloMap Registry), assessing the use of AlloMap as a surveillance solution for heart transplantation, will include new insights related to cytomegalovirus (CMV) infection. CMV is a common but severe viral infection that can occur in solid organ transplant recipients with weakened immune systems.

"We are excited to contribute to the emerging field of cell-free DNA, and present new insights from CARGO II, which will help to support the clinical translation of this science to the field of transplantation. These presentations at ISHLT also further strengthen the clinical evidence of AlloMap and provide insights into its clinical validity and utility in the heart transplant setting," said Peter Maag, President and Chief Executive Officer of CareDx.

Cell-Free DNA presentations:
Thursday, April 16th
Increased Plasma Levels of Donor-Derived Cell-Free DNA Correlate With Rejection in Heart Transplant Recipients: The CARGO II Multicenter Trial

  • 3:15 - 3:30 p.m. GMT
  • Concurrent Session: New Tools in the Fight Against Rejection

Friday, April 17th
Donor-Derived Cell-Free DNA Decreases Following Effective Treatment of Acute Cellular Rejection in Heart Transplant Recipients: The CARGO II Multicenter Trial

  • 5:00 - 5:15 p.m. GMT
  • Oral Session: A Heart Day's Night

Donor-Derived Cell-Free DNA Is Stable in Non-Rejecting Heart Transplant Recipients in the CARGO II Multicenter Trial

  • 6:20 - 6:25 p.m. GMT
  • Oral Session: A Heart Day's Night

OAR Registry presentations:
Thursday, April 16th
Gene-Expression Profiling to Monitor for Rejection - Which Patients Are Being Offered This Strategy?

  • 6:00 - 7:00 p.m. GMT
  • Poster Session: Heart Transplantation

Gender-Mismatched Heart Transplants and Gene-Expression Profiling Score -- Lessons From the Outcomes AlloMap Registry (OAR)

  • 6:00 - 7:00 p.m. GMT
  • Poster Session: Heart Transplantation

Friday, April 17th
Correlation of Longitudinal Gene-Expression Profiling (GEP) Score to Cytomegalovirus (CMV) Infection: Results From the Outcomes AlloMap Registry (OAR)

  • 5:15 - 5:30 p.m. GMT
  • Concurrent Session: Cloudy with a Chance of T-Cells: Rejection Forecast

Other clinical presentations with AlloMap:
Thursday, April 16th
Gene Expression Profiling to Optimize Immunosuppression in Long-Term Heart Transplant Recipients

  • 6:00 - 7:00 p.m. GMT
  • Poster Session: Heart Transplantation

Clinical Profiles and Outcomes of Cardiac Transplant Recipients Using AlloMap and Cylex Immuknow Assays

  • 6:00 - 7:00 p.m. GMT
  • Poster Session: Heart Transplantation

Friday, April 17th
Predictive Value of Gene Expression Profiling as Assessed By AlloMap Score for Long-Term Survival After Heart Transplantation

  • 5:30 - 5:45 p.m. GMT
  • Concurrent Session: Cloudy with a Chance of T-Cells: Rejection Forecast

A media briefing, "Further Advancements of Cell-Free DNA as an Important Biomarker for Transplant Recipients – CARGO II and Beyond" will take place on Thursday, April 16th, beginning at 8:00 a.m. PT (11:00 p.m. ET, 5:00 p.m. CEST). Additionally, an analyst and investor event, "The CareDx Cell-Free DNA Program – Updates from ISHLT" will also take place on April 16th, beginning at 8:30 a.m. PT (11:30 p.m. ET, 5:30 p.m. CEST). A live audio webcast for both events will be available on the Investor section of the CareDx website: www.caredx.com. Interested parties may participate by dialing (855) 420-0616 for US-domestic callers or (678) 304-6848 for international callers, please provide Conference ID: 22982776 when asked to be placed into the call.

About AlloMap®

AlloMap Molecular 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 (ACR) at the time of testing in conjunction with standard clinical assessment. AlloMap is performed in the CLIA-certified and CAP-accredited clinical laboratory at CareDx and has been commercially available in the United States since 2005. AlloMap was cleared by the U.S. Food and Drug Administration in 2008 and was CE marked for the European Union in 2011. Recommended use of AlloMap for heart transplant rejection surveillance is included in the International Society for Heart and Lung Transplantation (ISHLT) Guidelines for the care of heart transplant recipients, published in August, 2010. These guidelines represent the worldwide standard for the care of heart transplant patients.

About CareDx

CareDx, Inc., based in Brisbane, California, is a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value, non-invasive diagnostic surveillance solutions for transplant recipients. The Company has commercialized AlloMap®, a gene expression test that aids clinicians in identifying heart transplant recipients with stable graft function who have a low probability of moderate/severe acute cellular rejection. CareDx is also pursuing the development of additional products for post-transplant monitoring of other solid organs that use a variety of technologies, including next generation sequencing to detect donor-derived cell-free DNA to monitor the health of organs after transplantation. The Company is currently investigating a research use only donor-derived cell-free DNA-based test for heart transplant recipients. For more information, please visit: www.CareDx.com.

Forward Looking Statements

This press release contains forward-looking statements including, but not limited to statements regarding the Company's expectations regarding future potential, development and commercial activities. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward looking statements, including CareDx's limited operating history and experience with developing new markets; risk relating to new partnerships and commercialization of those relationships, as well as other risks stated in CareDx's filings with the SEC located at www.sec.gov. CareDx disclaims any obligation to publicly update or revise any forward looking statements to reflect events that occur or circumstances that exist after the date on which they were made.

CONTACT: CareDx, Inc. Bradley P. Sherrill Senior Director, Marketing bsherrill@CareDx.com 415-287-2397 Westwicke Partners, LLC Leigh J. Salvo Principal Tel: 415-513-1281 leigh.salvo@westwicke.com

Source:CareDx, Inc.