TIDMHZD
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."
- ENDS -
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)
Mary-Jane Elliott, Susan Stuart, Matthew Neal, Melissa
Gardiner
Tel: +44 (0) 20 3709 5701
Email: horizon@consilium-comms.com
Zyme Communications (Trade and Regional Media)
Katie Odgaard
Tel: +44 (0)7787 502 947
Email: katie.odgaard@zymecommunications.com
Numis Securities Limited (Joint Broker and NOMAD)
Michael Meade / Freddie Barnfield
Tel: +44 (0) 207 260 1000
RBC Capital Markets (Joint Broker)
Paul Tomasic / Marcus Jackson
Tel: +44 (0) 20 7653 4000
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
Tel: +1 415-287-2542
Email: twhitson@caredx.com
Westwicke Partners, LLC (Investors)
Jamar Ismail
Tel: +1 415-513-1282
Email: jamar.ismail@westwicke.com
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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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(END) Dow Jones Newswires
November 09, 2016 02:01 ET (07:01 GMT)
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