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CareDx, Horizon Discovery Collaborate on Cell-Free DNA Reference Standards

NEW YORK (GenomeWeb) – CareDx and Horizon Discovery Group today announced a collaboration to develop cell-free DNA reference standards. 

Horizon Diagnostics, a division of Horizon, will develop the HDx Reference Standards, which will support CareDx's solid organ transplant injury monitoring diagnostic tests and be integrated into CLIA laboratory testing, the firms said.  

HDx Reference Standards are genetically defined, quantitative, sustainable, and independent third-party reference material. The partners said they are critical to the validation and routine performance monitoring of CareDx's donor-derived, next-generation sequencing-based cfDNA diagnostic assay. They mimic plasma cfDNA in size and abundance in the transplant setting and are the first commercially available standards of their kind. 

CareDx currently has studies under way directed at cfDNA for monitoring heart and kidney transplant patients. The firm has a cfDNA test available for research use only with plans to launch it as a laboratory-developed test by the end of the year. An RUO cfDNA test for kidney transplants could become available by the end of this year or in early 2016, CareDx CEO Peter Maag told GenomeWeb recently.

"This new collaboration with CareDx demonstrates the importance of well-validated controls when developing clinical assays, especially as technologies such as NGS become more widely adopted for diagnostic use," Horizon Products Business President Paul Morrill said in a statement. 

Financial and other terms of the deal were not disclosed.