Horizon Discovery Group plc OEM Agreement with CareDx for Reference Standards

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Horizon Discovery Group plc

09 November 2016

Horizon Discovery 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 HDx(TM) 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(R), 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(R). 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.

References

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

For further information from Horizon Discovery Group plc, please contact:

Consilium Strategic Communications (Financial Media and Investor Relations)

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About Horizon Discovery Group plc www.horizondiscovery.com/

Horizon Discovery Group plc (LSE: HZD) ("Horizon"), is a world-leading gene editing company that designs and engineers genetically-modified cells and then applies them in research and clinical applications that advance human health.

Horizon's core capabilities are built around its proprietary translational genomics platform, a highly precise and flexible suite of gene editing tools (rAAV, ZFN and CRISPR) able to alter almost any gene sequence in human or mammalian cell-lines.

Horizon offers over 23,000 catalogue products and related research services, almost all of which are based on the generation and application of cell and in vivo models that accurately recapitulate the disease-causing genetic anomalies found in diseases like cancer. Horizon's commercial offering has been adopted by c1,600 unique research organisations in over 50 countries as well as in the Company's own R&D pipeline to support a greater understanding of the genetic drivers of disease and the development of molecular, cell and gene therapies that can be prescribed on a personalised basis.

Horizon is headquartered in Cambridge, UK, and is listed on the London Stock Exchange's AIM market under the ticker "HZD".

For further information from CareDx, please contact:

Marketing Contact

Todd Whitson

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Westwicke Partners, LLC (Investors)

Jamar Ismail

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About CareDx

CareDx, Inc., headquartered in Brisbane, California, is a global molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients. CareDx offers AlloMap(R) , a gene expression test that aids clinicians in identifying heart transplant patients with stable graft function who have a low probability of moderate to severe acute cellular rejection (ACR). CareDx is developing additional products for transplant monitoring using a variety of technologies, including AlloSure(R) , a proprietary next-generation sequencing-based test to detect donor-derived cell-free DNA (dd-cfDNA) after transplantation.

CareDx, with its presence through Olerup, also develops, manufactures, markets and sells high quality products that increase the chance of successful transplants by facilitating a better match between a donor and a recipient of stem cells and organs. Olerup SSP(R) is a set of HLA typing products used prior to hematopoietic stem cell/bone marrow transplantation and organ transplantation. XM-ONE(R) is the first standardized test that quickly identifies a patient's antigens against HLA Class I, Class II or antibodies against a donor's endothelium. For more information, please visit:www.CareDx.com.

Forward Looking Statements

In addition to historical information, this press release contains forward-looking statements with respect to the CareDx business, research, development and commercialization efforts and anticipated future financial results. 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 the continued successful development and planned commercialization of AlloSure, 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 as updated in subsequent filings. These risks and uncertainties 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.

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November 09, 2016 02:01 ET (07:01 GMT)