BRISBANE, Calif., Nov. 9, 2015 (GLOBE NEWSWIRE) — CareDx, Inc. (Nasdaq:CDNA), a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic surveillance solutions for transplant recipients, announced today that it has presented data from validation studies on its proprietary donor-derived cell-free DNA (dd-cfDNA) test at two national industry meetings earlier this month.
The first study, “Proficiency Testing For and Surveillance of Heart Transplant Health Using Donor-Derived Cell-Free DNA” presented at the Association for Molecular Pathology (AMP) Annual meeting in Austin, Texas on November 5, characterized the analytical performance of the dd-cfDNA test.1 The results describe the high precision and accuracy of a dd-cfDNA test for solid organ transplantation using sheared cell line DNA panels independently verified by digital PCR. The computational analysis pipeline for this study incorporated both open source and custom NGS bioinformatics as part of a collaboration with DNAnexus announced earlier this year.
In a late breaking poster “Donor-derived Cell-free DNA in Plasma Increases with Rejection and Decreases after Treatment in Kidney Transplant Recipients” presented at the American Society of Nephrology Annual Meeting in San Diego on November 7, CareDx presented data from a study that demonstrated that elevated levels of dd-cfDNA are present in transplanted kidney patients with biopsy-confirmed rejection, while there are decreased levels of dd-cfDNA following treatment for rejection. 2 In contrast, this study showed that levels of the commonly used biomarker of kidney function, serum creatinine, were indistinguishable between the rejection and quiescent patients.
Both studies provide important data to support the CareDx proprietary analytically validated donor-derived cell-free DNA (dd-cfDNA), which the Company anticipates will be made available later this year from its CLIA lab. Copies of both posters can be found at:
Peter Maag, CareDx CEO, stated, “These studies combine the latest advances in genomics and bioinformatics technology, and also show how dd-cfDNA can be used in kidney transplant recipients. With this approach, CareDx continues to be at the forefront in the development of novel transplant patient surveillance solutions.”
1 Woodward R et al, Poster TT63, November 2015. http://www.amp.org/meetings/2015/
2 Grskovic, M et al, Poster SA-PO1124, November 2015. http://www.asn-online.org/education/kidneyweek/2015/KW15_Late-Breakers.pdf
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. 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.
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