AlloSure Detects Active Rejection in Kidney Transplant Patients

BRISBANE, Calif., Nov. 18, 2016 -- CareDx, Inc. (Nasdaq:CDNA), a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients, has presented compelling AlloSure data at the American Society of Nephrology Annual Meeting.

AlloSure is a clinical-grade proprietary Next-Generation Sequencing (NGS) based test to detect donor-derived cell-free DNA (dd-cfDNA) in solid organ transplant recipients. The DART clinical trial is a landmark study for CareDx with 14 transplant centers across the United States. The study started in 2015 and this first analysis is from a dataset with 1272 samples from 384 patients. 

Key takeaways from the data:

• AlloSure differentiates “Active Rejection” from “Non Rejection”
• Assay has sensitivity of 59% and specificity of 85% at a 1% threshold
• AlloSure provides PPV of 60% at a 1% threshold and 85% at a 3% threshold
• AlloSure provides NPV of 84% at a 1% threshold and 80% at a 3% threshold

A summary of the data can be found in the following poster presentation (FR-PO1133).
Link: www.caredx.com//wp-content/uploads/2016/11/ASN-2016_27-11Nov2016-FINAL.pdf

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

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 including, but not limited to our business, research, development and commercialization efforts and anticipated future financial results. 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 the continued successful development and planned commercialization of AlloSure, that are described in our filings with the SEC, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2015 filed by us with the SEC on March 29, 2016 and the Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2016 filed by us with the SEC on November 15, 2016.  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.

Investor Relations Contact
Jamar Ismail, Vice President
Westwicke Partners, LLC 
T: +1 415-513-1282
E:  [email protected]