Epigenomics AG (FWB:ECX), the cancer molecular diagnostics
company, and QIAGEN (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA)
today announced that the companies have entered into an option
agreement allowing QIAGEN to develop and, should QIAGEN exercise
the option, commercialize a colorectal cancer blood test based on
Epigenomics’ proprietary biomarker mSEPT9 and certain DNA
methylation analysis technologies.
Under the terms of the agreement, QIAGEN receives an option to a
worldwide non-exclusive commercial license to Epigenomics’
proprietary mSEPT9 biomarker and DNA methylation technologies for
the detection of colorectal cancer in blood. The option can be
exercised by QIAGEN within the next two years. Furthermore,
Epigenomics has granted QIAGEN a research license to the mSEPT9
biomarker and the technologies. Under this license, QIAGEN is
currently developing a novel sample preparation technology that
meets the requirements for the future broad implementation of
methylation-based molecular diagnostics, such as Septin9-targeted
blood testing for the detection of colorectal cancer, on QIAGEN’s
modular molecular testing platform QIAsymphony. Epigenomics will
support QIAGEN in the R&D phase through know-how transfer and
the collection of clinical specimens as required.
Geert Nygaard, CEO of Epigenomics, commented: “With a clear
focus on cancer molecular diagnostics and proven excellence in its
fully integrated sample preparation and assay technology platforms
for molecular testing, QIAGEN is an ideal further partner to give
laboratories and thereby physicians and patients broad access to
colorectal cancer blood testing as a convenient addition to
currently available methods for early detection. This new agreement
significantly expands our existing long-lasting and successful
partnership with QIAGEN, and we are looking forward to moving this
project to the next stage.”
Under the terms of the option agreement, Epigenomics will
receive an upfront payment from QIAGEN and will be reimbursed for
any R&D support and clinical specimens provided during the
R&D phase. Upon QIAGEN exercising the option Epigenomics would
receive a further license payment. Once QIAGEN commercializes a
colorectal cancer blood test based on Epigenomics’ biomarkers and
technology, Epigenomics would be entitled to royalties on QIAGEN’s
net sales as well as certain commercial milestones upon reaching
specific revenue targets.
“This agreement adds to our content pipeline and further
broadens the menu of assays optimized for superior performance on
our novel modular QIAsymphony and QIAensemble platforms”, says
Ulrich Schriek, Vice President Global Business Development at
QIAGEN. ”QIAGEN has several ongoing programs which target to expand
our “Prevention” assay portfolio which currently includes
infectious disease assays as well as HPV screening for the early
detection of cervical cancer risks. Prevention assays are key
contributors to early detection of disease and to significant
reduction of disease burden.”
By signing this agreement with QIAGEN, Epigenomics continues to
implement its dual business strategy of direct global
commercialization of its colorectal cancer blood test, under its
own brand name Epi proColon, and non-exclusive licensing of its
proprietary mSEPT9 biomarker and DNA methylation technologies to
leading companies in the diagnostic industry. Epigenomics employs
this strategy to maximize access to colorectal cancer blood testing
on a range of diagnostic instrument platforms and accelerate
adoption of this innovative and patient-friendly approach to the
early detection of colorectal cancer. Today, Septin9 blood testing
for colorectal cancer is available in Europe, the Middle East,
Asia/Pacific and the U.S.A. based on CE-marked diagnostic products
and laboratory-developed tests by Epigenomics and its licensing
partners.
Notes to the Editor
About the Septin9 Biomarker and Colorectal Cancer Blood
Tests
The mSEPT9 biomarker is at the core of the world’s first
molecular diagnostic blood tests for the detection of colorectal
cancer commercialized by Epigenomics (Epi proColon) and its partner
Abbott Molecular (mS9) as IVD test kits in Europe and Asia/Pacific
and its licensees Quest Diagnostics (ColoVantage™), ARUP
Laboratories (Methylated Septin9 Test), and Warnex Laboratories
(Septin9 Test) as laboratory-developed tests in the US and Canada,
respectively. The tests all detect cell-free methylated DNA of the
SEPT9 gene, which is indicative of the presence of colorectal
cancer.
In numerous studies, Epigenomics and its partners have
demonstrated that the detection of the mSEPT9 biomarker in blood
plasma correlates with the presence of colorectal cancer and thus
can be used as an aid in the detection of this common cancer. These
studies include the successfully completed PRESEPT Study, a
prospective evaluation of the Septin9 biomarker in a cohort of
almost 8,000 individuals representative of a typical screening
population.
Today, mSEPT9 is likely the most thoroughly tested and best
studied molecular diagnostic biomarker for colorectal cancer
detection.
Lack of patient adherence to screening recommendations is the
biggest hurdle to an effective screening for colorectal cancer.
Experts believe that a blood test that is more convenient for the
patients than stool tests and colonoscopy could encourage more
people to be screened and thus be of medical and health economic
benefit.
About Epigenomics
Epigenomics (www.epigenomics.com) is a cancer molecular
diagnostics company developing and commercializing a pipeline of
proprietary products. The Company’s products enable doctors to
diagnose cancer earlier and more accurately, leading to improved
outcomes for patients. Epigenomics’ lead product, Epi proColon, is
a blood-based test for the early detection of colorectal cancer,
which is currently marketed in Europe and is in development for the
U.S.A. The Company’s technology and products have been validated
through multiple partnerships with leading global diagnostic
companies including Abbott, QIAGEN, Sysmex, and Quest Diagnostics.
Epigenomics is an international company with operations in Europe
and the U.S.A.
Epigenomics’ legal disclaimers. This communication
expressly or implicitly contains certain forward-looking statements
concerning Epigenomics AG and its business. Such statements involve
certain known and unknown risks, uncertainties and other factors
which could cause the actual results, financial condition,
performance or achievements of Epigenomics AG to be materially
different from any future results, performance or achievements
expressed or implied by such forward-looking statements.
Epigenomics AG is providing this communication as of this date and
does not undertake to update any forward-looking statements
contained herein as a result of new information, future events or
otherwise.
The information contained in this communication does not
constitute nor imply an offer to sell or transfer any product, and
no product based on this technology is currently available for sale
by Epigenomics in the United States or Canada. The analytical and
clinical performance characteristics of any Epigenomics product
based on this technology which may be sold at some future time in
the U.S. have not been established.
About QIAGEN
QIAGEN N.V., a Netherlands holding company, is the leading
global provider of sample and assay technologies. Sample
technologies are used to isolate and process DNA, RNA and proteins
from biological samples such as blood or tissue. Assay technologies
are used to make such isolated bio-molecules visible. QIAGEN has
developed and markets more than 500 sample and assay products as
well as automated solutions for such consumables. The company
provides its products to molecular diagnostics laboratories,
academic researchers, pharmaceutical and biotechnology companies,
and applied testing customers for purposes such as forensics,
animal or food testing and pharmaceutical process control. QIAGEN's
assay technologies include one of the broadest panels of molecular
diagnostic tests available worldwide. This panel includes the
digene HPV Test, which is regarded as a "gold standard" in testing
for high-risk types of human papillomavirus (HPV), the primary
cause of cervical cancer, as well as a broad suite of solutions for
infectious disease testing and companion diagnostics. QIAGEN
employs nearly 3,600 people in over 35 locations worldwide. Further
information about QIAGEN can be found at www.qiagen.com.
QIAGEN’s legal disclaimer. Certain of the statements
contained in this news release may be considered forward-looking
statements within the meaning of Section 27A of the U.S. Securities
Act of 1933, as amended, and Section 21E of the U.S. Securities
Exchange Act of 1934, as amended. To the extent that any of the
statements contained herein relating to QIAGEN's products, markets,
strategy or operating results, and to expected growth of QIAGEN's
business in India in particular, are forward-looking, such
statements are based on current expectations that involve a number
of uncertainties and risks. Such uncertainties and risks include,
but are not limited to, risks associated with management of growth
and international operations (including the effects of currency
fluctuations and risks of dependency on logistics), variability of
operating results, the commercial development of the applied
testing markets, clinical research markets and proteomics markets,
nucleic acid-based molecular diagnostics market, and genetic
vaccination and gene therapy markets, competition, rapid or
unexpected changes in technologies, fluctuations in demand for
QIAGEN's products (including fluctuations due to the level and
timing of customers' funding, budgets, and other factors), our
ability to obtain regulatory approval of our infectious disease
panels, difficulties in successfully adapting QIAGEN's products to
integrated solutions and producing such products, the ability of
QIAGEN to identify and develop new products and to differentiate
its products from competitors' products, market acceptance of
QIAGEN's new products and the integration of acquired technologies
and businesses. For further information, refer to the discussions
in reports that QIAGEN has filed with, or furnished to, the U.S.
Securities and Exchange Commission (SEC).
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