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Press Release

CareDx Describes Extensive Analytical Validation Data on AlloSure Robustness at American Association of Clinical Chemistry Annual Meeting


Posted on: 04 Aug 17

BRISBANE, Calif., Aug. 04, 2017 (GLOBE NEWSWIRE) -- CareDx, Inc. (NASDAQ:CDNA), a molecular diagnostics company focusing on the discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients, described rigorous evidence of the analytical robustness of AlloSure testing at the annual American Association of Clinical Chemistry Annual Meeting on Wednesday, August 2, 2017. 

Two presentations highlighted the best-in-class analytical performance of AlloSure, CareDx’s non-invasive laboratory developed test intended to assess the probability of allograft rejection in kidney transplant recipients with clinical suspicion of rejection and to inform clinical decision-making about the necessity of invasive kidney biopsy. 

  • B-443: Evaluation of Cell-Free DNA Recovery During Extraction Using a Next Generation Sequencing Assay 
  • B-444: Standardized Reagent Formulation and Data-driven QC Criteria Ensure Efficient and Consistent Delivery of Plasma Cell-free DNA Results for Organ Transplant Rejection

The studies presented demonstrate the reproducibility, linearity and robust recovery of cell free DNA (cfDNA) from patient plasma, and the development of clinical-grade standardized reagents and cGMP processes used in the manufacture of AlloSure. “This level of analytical assay development, process control, and integration of National Institute of Standards and Technology first genome reference material provides the utmost confidence in the accurate measurement of the exceptionally low amounts of donor derived cfDNA found in kidney transplant patients,” states Mitch Nelles, Ph.D. Chief Operating Officer of CareDx. 

About CareDx
CareDx, Inc., headquartered in Brisbane, California, is a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value solutions for transplant recipients. CareDx offers products across the transplant testing continuum, including AlloMap® and AlloSure™ for post-transplant surveillance and Olerup SSP®, Olerup QTYPE®, and Olerup SBT™ for pre-transplant HLA testing.

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, 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 14, 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.

CONTACT: Contact Sasha King, Chief Commercial Officer T: +1 415-287-2393 E: sking@caredx.com GlobeNewswire
globenewswire.com

Last updated on: 07/08/2017

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