Horizon Discovery Ltd. And CareDx Enter Into OEM Agreement For Routine Inclusion Of Cell-Free DNA Reference Standards In Transplant Testing

• Agreement builds on existing collaboration to develop cell-free DNA (cfDNA) Reference Standards to support CareDx’s solid organ transplant injury monitoring tests

• Ongoing collaboration supports strategy to provide reliable revenue through the inclusion of Horizon’s HDxTM Reference Standards in established assay workflows

Cambridge, UK, 9 November 2016: Horizon Discovery Group plc (LSE: HZD) ("Horizon"), the world leader in the application of gene editing technologies, today announces it has entered into an Original Equipment Manufacturer (OEM) agreement with CareDx®, Inc. (“CareDx”), a molecular diagnostics company focused on the discovery, development and commercialisation of clinically differentiated, high-value, diagnostic surveillance solutions for transplant patients.

Under the terms of the new agreement, Horizon will supply cell-free DNA-based Molecular Reference Standards for inclusion in CareDx’s cfDNA testing workflows for the monitoring of transplanted organ rejection. Financial details of the agreement were not disclosed.

The agreement is an extension of a previously announced collaboration for the development of HDx cell-free Reference Standards to support proficiency testing of CareDx’s solid organ transplant injury monitoring test, AlloSure®. As Horizon is CareDx’s chosen partner for the development of reference standards, future agreements between the two companies are expected.

The lack of standardisation in molecular diagnostics is a major source of error in laboratories worldwide, with studies citing error rates as high as 30%1. To provide optimal accuracy, laboratories benefit from reference materials, such as Horizon’s HDx Reference Standards, that reflect patient samples and are renewable, consistent and reproducible.

Dr. Darrin M. Disley, Chief Executive Officer, Horizon Discovery, commented: “The inclusion of Horizon’s Reference Standards as a routine tool used by CareDx demonstrates that Horizon is becoming a trusted provider of controls in the liquid biopsy space, and that they are equally valuable for applications beyond oncology. This agreement further validates Horizon’s strategy of entering into early development programmes with assay service providers and kit vendors, and working closely with them to forge long-term relationships and establish ongoing OEM-based revenue streams.”

Dr. John J. Sninsky, Chief Scientific Officer, CareDx, commented: “At CareDx, it is our goal to accelerate patient access to high quality clinical data using next-generation sequencing technology. Our ongoing partnership with Horizon is an important part of this effort, and our confidence has only increased with their having successfully driven this programme to completion and inclusion in our testing workflow.”

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Notes for Editors:

About HDx Reference Standards

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, AlloSure. The reference standards mimic plasma cfDNA both in size and abundance in transplant setting and are the first commercially available standards of their kind.

About AlloSure

CareDx’s AlloSure 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 recipients living in the US. The AlloSure assay amplifies approximately 250 loci of the human genome to identify transplant donor-recipient pairs ranging from diverse ancestral heritage to closely related kindred. AlloSure offers a simpler alternative to assays requiring donor and recipient genotyping to simplify assay implementation.


1. External Quality Assessment for KRAS Testing Is Needed: Setup of a European Program and Report of the First Joined Regional Quality Assessment Rounds, The Oncologist 2011;16:467–478

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