Horizon Discovery announces inclusion of its Reference Standards in successful FDA approval of an oncology companion diagnost...
July 03 2017 - 7:01AM
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 20171 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 patients2. 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 €6 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."
- https://seer.cancer.gov/statfacts/html/colorect.html
-
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
- https://seer.cancer.gov/statfacts/html/colorect.html
-
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 plcDarrin Disley,
Chief Executive OfficerRichard Vellacott, Chief Financial
OfficerChris 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 GardinerTel: +44 (0) 20 3709 5701Email:
horizon@consilium-comms.com
Zyme Communications (Trade and Regional
Media)Katie OdgaardTel: +44 (0)7787 502 947Email:
katie.odgaard@zymecommunications.comTel: +44 (0) 20 7653 4000
About Horizon Discovery Group plc
www.horizondiscovery.comHorizon 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".
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