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Horizon’s standards to support proficiency testing of CareDx solid organ transplantation injury monitoring diagnostic assay

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 and Horizon Discovery Group plc (Horizon), an international life science company supplying reagent tools and services that power genomics research and the development of personalized medicines, today announced they have entered into a collaboration to develop cell-free DNA (cfDNA) reference standards. These HDx™ Reference standards, being developed by Horizon Diagnostics, a division of Horizon, will support proficiency testing of CareDx’s solid organ transplant injury monitoring diagnostic tests and will be integrated into CLIA laboratory testing.

HDx Reference Standards offer a source of genetically defined, quantitative, sustainable and independent third party reference material, critical to the validation and routine performance monitoring of CareDx’s next generation sequencing (NGS) based donor-derived cfDNA (dd-cfDNA) diagnostic assay. The reference standards mimic plasma cfDNA both in size and abundance in transplant setting and are the first commercially available standards of their kind.

Horizon Diagnostics uses its proprietary genome engineering platforms to precisely engineer highly characterized parental cell lines. Horizon Diagnostics then generates mixtures at very precise allelic frequencies, verified by digital PCR, ranging between 0.1% and 50%.

CareDx’s cfDNA test is designed to monitor injury to transplanted organs, in particular heart and kidney in transplant recipients to allow clinicians to better manage patient health outcomes. There are approximately 300,000 solid organ transplant patients living in the US. The assay amplifies approximately 250 loci of the human genome to identify transplant donor-recipient pairs with diverse ancestral heritage as well as those with close familial relationships.  The CareDx cfDNA assay offers a simpler alternative to assays requiring donor and recipient genotyping to simplify assay implementation.

CareDx’s cfDNA test follows recent guidance for next generation sequencing (NGS) outlined by Association of Molecular Pathology (AMP), American College of Medical Genetics (ACMG) and Clinical Laboratory Standards Institute (CLSI). The targeted assay was recognized in the "What's Hot, What's New" session at the American Transplant Congress in Philadelphia on May 6, 2015.

Dr. Paul Morrill, President, Products Business, Horizon, said: “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 is committed and motivated to be working with CareDx on the development of cell-free DNA reference standards within the solid organ transplant field, taking our reference standard technology into a new area beyond Oncology."

Dr. John J. Sninsky, CSO of CareDx, commented: “I have been working with Horizon’s scientists for more than five years, and am continually impressed by their understanding of diagnostic requirements. At CareDx, it is our goal to accelerate patient access to clinical data using next generation sequencing technology. This collaboration with Horizon has the potential to advance us to this goal, and demonstrates CareDx’s continued quality and regulatory leadership.”

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