CareDx to Present Key AlloSure Validation Data at ATC

BRISBANE, Calif., April 28, 2017 -- CareDx, Inc. (NASDAQ:CDNA) and collaborators will present data highlighting the AlloSure test at the American Transplantation Congress (ATC) from April 29 – May 3, 2017 in Chicago. AlloSure is the first and only noninvasive test that uses donor-derived cell-free DNA (dd-cfDNA) as a biomarker to directly measure allograft injury, enabling determination of the probability of active rejection.

CareDx will host a symposium summarizing the value of dd-cfDNA as a biomarker (Dr. Roslyn B. Mannon), the clinical validation of dd-cfDNA test AlloSure (Dr. Roy D. Bloom), and the intended use and patient case studies (Dr. Daniel C. Brennan).

“There is a major need for better solutions in transplant immunologic monitoring.  Donor-derived cell-free DNA may enable more frequent and less invasive monitoring of kidney transplants,” said Anthony Langone, MD, Medical Director of the Medical Specialties Clinic, Vanderbilt University Medical Center. “AlloSure could potentially be used in a wide array of patients to detect active rejection of the kidney and in particular antibody mediated rejection.”

The oral presentation, “Donor-Derived Cell-Free DNA Correlates with Antibody-Mediated Rejection in Kidney Allografts” will be delivered at ATC by Dr. Roy D. Bloom on Tuesday, May 2^nd at 2:30pm. Analysis of data from a large prospective multi-center study determined the correlation of dd-cfDNA with T cell mediated rejection (TCMR) and antibody mediated rejection (ABMR). The study found that dd-cfDNA may be used to assess allograft rejection and injury; levels >1% indicate a high probability of ABMR. dd-cfDNA levels below 1% reflect absence of ABMR.

There will be other presentations featuring AlloSure:

• “Donor-Derived Cell-Free DNA is a Dynamic Biomarker of Active Rejection in Kidney Allografts” on Sunday, April 30^th at 6pm.  This presentation describes the ability of AlloSure to monitor patient recovery after treatment for active rejection.   
• “Donor-Derived Cell-Free DNA Normal Range and Biological Variation Defined in a Reference Population”, presented on Sunday, April 30^th at 6pm. 
• “Donor-Derived Cell-Free DNA Predicts Biopsy-Proven Acute Cellular Rejection in Pediatric Kidney Transplant Recipients”, presented on Tuesday, May 2^nd at 4:50pm.
• “Donor-Derived Cell-Free DNA Parallels Increases in Donor Specific Antibodies in Pediatric Kidney Transplant Recipients”, presented on Tuesday, May 2^nd at 6pm.

Additionally, there will be a presentation on CareDx’s gene expression test for monitoring heart rejection, AlloMap. “Routine Surveillance of Heart Transplant Recipients with Gene Expression Profiling: Lack of an Impact of Race on Outcomes” will be presented on Monday, May 1^st at 6pm.

“We look forward to communicating the clinical validation of AlloSure at ATC this year. AlloSure meets the compelling need for accurate, noninvasive kidney transplant monitoring, and the studies described at ATC represent major steps toward the use of the test in clinical practice,” said Todd Whitson, Chief Commercial Officer at CareDx, Inc.

Additional information on CareDx presentations and data can be found at the CareDx booth at ATC (Booth #227).

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.  CareDx is 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.

CareDx, with its presence through Olerup, also develops, manufactures, markets and sells high quality products that increase the chance of successful transplants by facilitating a better match between a donor and a recipient of stem cells and organs.

For more information, please visit: www.CareDx.com.  

Forward Looking Statements
This press release contains forward-looking statements about our business, research, development and commercialization efforts including, but not limited to the development, commercialization, utility, performance and adoption of AlloSure. These forward-looking statements are based upon information that is currently available to us and our current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, including risk associated with successful research, development and planned commercialization of our technologies, that are described in our filings with the SEC, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2016 filed by us with the SEC on April 21, 2017.  Any of these may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. We expressly disclaim any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.

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