TIDMHZD
Horizon Discovery Group plc
03 July 2017
Horizon Discovery announces inclusion of its Reference Standards
in successful FDA approval of an oncology companion diagnostic test
with leading next generation sequencing company
-- Horizon's reference standards supported assay development and subsequent clinical trial
-- Horizon is a leader in the application of cancer biomarkers in diagnostics and research
Cambridge, UK, 3 July 2017: Horizon Discovery Group plc (LSE:
HZD) ("Horizon" or the "Company"), the world leader in the
application of gene editing technologies, today announces the use
of its Reference Standards in a recent successful premarket
approval application (PMA) filing with the FDA for a companion
diagnostic in oncology by a leading next generation sequencing
company. In the development and subsequent clinical trial,
Horizon's Reference Standards were used as positive controls to
support the programme and to help establish the performance
specifications of the assay.
Horizon is a leading provider of highly characterised genetic
materials used as Reference Standards for the development and
quality control of molecular assays. Increasingly the Company works
with assay developers early in their process to support the
efficient development and validation of new tests, often with the
Reference Standards becoming part of the kit and Horizon receiving
a portion of revenues, as was the case in a previously announced
agreement (12 May 2016) with a global market leading Next
Generation Sequencing (NGS) platform company.
Horizon has played a major role in the identification and
application of the critical biomarkers of cancer since its
inception. Horizon's genetic markers are made available to
researchers via its significant catalogue of products in the form
of gene edited cell lines, and to clinical labs in the form of
Reference Standards that mimic real patient samples.
Colorectal cancer is one of the most commonly diagnosed cancers
in both men and women, with an estimated 135,000 new cases expected
to be diagnosed in 2017(1) in the United States alone. Current
front-line colorectal cancer drugs exist in the forms of Erbitux
and Vectibix, however not all patients respond to the therapeutics.
Studies from Professor Alberto Bardelli (a Horizon co-founder) and
Dr. Sabine Tejpar (a Horizon SAB member), published in the Journal
of Cancer Research (March 2007 and February 2009) and the Journal
of Clinical Oncology (October 2008), first made the link between
K-RAS mutations and resistance to these drugs in up to 65% of colon
cancer patients(2) . This work provided critical evidence that led
to the requirement for clinicians to test patients for K-RAS
mutation status prior to their prescription, not only enabling
patients to obtain the right drug for their cancer, but also saving
an estimated $750 million/year through avoidance of prescriptions
that would provide no patient benefit.
Horizon continued to build on this work through the COLTHERES
consortium, a four year EUR6 million funded collaboration of
EU-based clinical centers and translational researchers, that
identified additional biomarkers in the 30-40% of patients who are
resistant to Cetuximab, a therapeutic for the treatment of advanced
colorectal cancer. This work led to multiple ongoing clinical
trials for combination therapies, and resulted in several technical
innovations including the first practical use of liquid biopsy for
diagnostics, the full impact of which is now being realised.
Dr. Darrin M Disley, Chief Executive Officer, Horizon Discovery,
commented: "Due to our deep-seated experience, Horizon is a
world-leader in the development of cell-based models of human
disease and their application in a wide range of fields, including
to support the accurate and efficient provision of critical
oncology diagnostic testing. We are pleased that our Reference
Standards have proven such a valuable component of this seminal
clinical trial and FDA approval with one of the world's leading
players in the genomics and diagnostics market. We are currently
supporting many similar trials and products and look forward to
making an impact on the lives of patients through our
products."
1. https://seer.cancer.gov/statfacts/html/colorect.html
2.
https://www.horizondiscovery.com/about-us/news/horizona-s-x-man-cell-models-predict-that-a-subset-of-kras-mutated-cancers-respondto-egfr-therapy
ENDS
About Horizon's Reference Standards:
There are many potential sources of variability that can lead to
molecular diagnostic tests providing erroneous results. Our
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 assays, providing an unprecedented level of control.
Horizon Reference Standards are available in a broad range of
formats, including Formalin-Fixed Paraffin-Embedded (FFPE) cell
line sections, purified genomic DNA (gDNA), and cell-free DNA
(cfDNA) on its own or spiked into synthetic plasma.
Glossary:
-- Assay: a laboratory procedure measuring the presence, amount,
or functional activity of a specific biomarker or analyte
-- Liquid biopsy: the sampling and analysis of non-solid biological tissue, primarily blood
-- K-RAS: a protein that in humans is encoded by the KRAS gene
-- Next Generation Sequencing (NGS): high-throughput sequencing
of DNA (or RNA) by parallelising the sequencing process, producing
thousands or millions of sequences concurrently
-- Reference standard: a standardised substance (e.g. DNA,
protein) which is used as a measurement base or control for an
assay
1. https://seer.cancer.gov/statfacts/html/colorect.html
2.
https://www.horizondiscovery.com/about-us/news/horizona-s-x-man-cell-models-predict-that-a-subset-of-kras-mutated-cancers-respondto-egfr-therapy
For further information from Horizon Discovery Group plc, please
contact:
Horizon Discovery Group plc
Darrin Disley, Chief Executive Officer
Richard Vellacott, Chief Financial Officer
Chris Claxton, VP Investor Relations
Tel: +44 (0) 1223 655 580
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
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, CRISPR and Transposon) 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 animal models that accurately
recapitulate the disease-causing genetic anomalies found in
diseases like cancer. Horizon's commercial offering has been
adopted by over 1,600 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".
This information is provided by RNS
The company news service from the London Stock Exchange
END
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