Tous Actualités
Suivre
Abonner Epigenomics AG

Epigenomics AG

EANS-News: Epigenomics AG Initiates Testing of Blood Plasma Samples from PRESEPT Study in Three Independent Clinical Laboratories

PRESEPT Study evaluates clinical performance and health economic 
benefit of colorectal cancer screening with mSEPT9 blood test
Quest Diagnostics, ARUP Laboratories, and Charité - 
Universitätsmedizin Berlin selected to test mSEPT9 biomarker in blood
plasma samples from PRESEPT Study subjects
Laboratories to use 
recently launched Epi proColon CE Marked IVD test products for the 
testing of the PRESEPT medical research study samples
Selection 
of about 1,500 masked blood samples to be tested in several batches -
data analysis after last sample of last batch is tested
PRESEPT 
enrollment now exceeds 6,400 subjects with more than three quarters 
of targeted 50 colorectal cancer cases accrued
Laboratories to 
start testing in October - completion expected late 2009 or early 
2010
  Corporate news transmitted by euro adhoc. The issuer/originator is solely
  responsible for the content of this announcement.
Company Information/Research & Development/Molecular diagnostics
Utl.: PRESEPT Study evaluates clinical performance and health 
economic benefit of colorectal cancer screening with mSEPT9 blood 
test
Quest Diagnostics, ARUP Laboratories, and Charité - 
Universitätsmedizin Berlin selected to test mSEPT9 biomarker in blood
plasma samples from PRESEPT Study subjects
Laboratories to use recently launched Epi proColon CE Marked IVD test
products for the testing of the PRESEPT medical research study 
samples
Selection of about 1,500 masked blood samples to be tested in several
batches - data analysis after last sample of last batch is tested
PRESEPT enrollment now exceeds 6,400 subjects with more than three 
quarters of targeted 50 colorectal cancer cases accrued
Laboratories to start testing in October - completion expected late 
2009 or early 2010  =
Press release, Berlin, Germany, and Seattle, WA, USA, October 08, 
2009 (euro adhoc) - Epigenomics AG (Frankfurt Prime Standard: ECX), a
molecular diagnostics company focusing on the development and 
commercialization of in vitro diagnostic (IVD) products for early 
cancer detection, today announced that it has initiated the testing 
of the biomarker mSEPT9 in plasma samples collected in the PRESEPT 
Study. Subject enrollment into the study at 32 clinical sites is 
ongoing and progressing well.
PRESEPT is a prospective multi-center, multi-national clinical 
research study to evaluate the performance characteristics and health
economic benefit of colorectal cancer screening using the mSEPT9 
blood test in a representative asymptomatic screening eligible 
population. Once completed, the PRESEPT Study will be the largest 
commercially sponsored colorectal cancer screening studies ever 
conducted.
Enrollment as of early October already exceeded 6,400 subjects among 
which more than three quarters of the targeted 50 colorectal cancer 
cases have been identified by colonoscopy. Epigenomics expects to 
reach its original enrollment target of around 7,500 subjects during 
Q4 of 2009 but will continue enrolling until the study population 
comprises 50 colorectal cancer cases, a target expected to be reached
either in late 2009 or early 2010.
mSEPT9 testing will be performed by three independent high-profile 
laboratories, namely Quest Diagnostics Incorporated headquartered in 
Madison, NJ, U.S.A., ARUP Laboratories, Salt Lake City, UT, USA and 
the Institute of Laboratory Medicine and Pathobiochemistry of Charite
- Universitätsmedizin Berlin, Germany. Each has passed a rigorous 
quality audit as well as extensive training and qualification with 
the mSEPT9 assay procedure before being selected for the study. The 
laboratories will use the recently launched CE-marked Epi proColon 
test kit to detect the mSEPT9 biomarker in the PRESEPT blood samples 
for this research study. The contracted laboratories will measure the
mSEPT9 biomarker in a combined total of about 1,500 blood plasma 
samples collected in the PRESEPT Study. Following a predefined 
statistical analysis plan this subset of the about 7,500 PRESEPT 
blood plasma samples will include all 50 CRC cases, several hundred 
cases with polyps and a random selection of about 900-1000 
colonoscopy-verified subjects with no evidence of disease as 
controls. Following the processing of all samples, the results of 
mSEPT9 testing will be compared to the findings by colonoscopy plus 
the histopathology of the polyps and cancer cases by an independent 
biostatistical group at the University of Minnesota.
The plasma samples to be tested are being selected by the Study 
Principal Investigator and subject identity or clinical status are 
masked to the testing laboratories. Thus, throughout mSEPT9 testing 
neither Epigenomics nor its laboratory partners will know the 
identity of the subjects corresponding to the samples or the 
colonoscopy results of the respective subjects. The biostatistical 
group will unmask the samples and compare the results of mSEPT9 
testing with the findings in colonoscopy after all of the ~ 1,500 
blood samples are analyzed for the mSEPT9 biomarker.
The blood plasma samples will be processed in several batches, the 
first of which will be tested in the first half of October with 
further batches scheduled for later in October, November, and 
December. Testing of the last batch will commence once the 50th 
cancer subject is identified. Each batch will contain randomized, 
masked samples from cancer and polyp cases, and control subjects with
no evidence of disease. After unmasking and data analysis, the Study 
Principal Investigator along with the PRESEPT Study independent 
oversight group, the Clinical Study Steering Committee, will 
accurately report the results of the PRESEPT Study according to the 
highest standards of scientific and clinical research.
Epigenomics expects that preliminary results will be available either
late in 2009 or early 2010. The detailed results of the PRESEPT Study
will subsequently be submitted for publication in a top-tier 
peer-reviewed journal and presented at major medical conferences in 
the first half of 2010.
"With the start of blood plasma sample testing we have reached an 
important milestone in the PRESEPT clinical study and have entered 
the home stretch for completion", stated Cathy Lofton-Day, PhD, 
Project Manager of PRESEPT at Epigenomics, Inc., Seattle. "We believe
that all three laboratories are excellent choices for testing the 
samples and generating data for mSEPT9 biomarker performance in the 
PRESEPT cohort", she added.
"Choosing to go with high-quality external clinical laboratories will
add significant credibility to the PRESEPT Study results and should 
demonstrate the robustness of our assay in routine clinical 
laboratory settings", Michael Wandell, PharmD, Study Director 
PRESEPT, Epigenomics Inc., Seattle remarked. "We are using our Epi 
proColon kit to measure the PRESEPT samples. This kit has recently 
been CE marked and is commercially available to clinical laboratories
as an IVD test kit in Europe through Epigenomics' direct marketing 
and sales organization."
Geert Nygaard, CEO of Epigenomics AG, further stated: "Demonstrating 
the performance of our Epi proColon IVD blood test in this 
prospective screening cohort will be of tremendous value to our 
marketing efforts in Europe and in making the Septin9 blood test a 
widely accepted additional option for colorectal cancer screening."
Further Information
For further information on PRESEPT, please visit HYPERLINK 
"http://www.presept.net"www.presept.net or clinicaltrials.gov 
(Identifier: NCT00855348).
More information on the partner laboratories can be found on their 
respective web sites: Quest Diagnostics: HYPERLINK 
"http://www.questdiagnostics.com"www.questdiagnostics.com ARUP 
Laboratories: {www.aruplab.com}[HYPERLINK: http://www.aruplab.com] 
ZLP, Charité - Universitätsmedizin Berlin: zlp.charite.de (German)
About Epi proColon
Epi proColon is a CE-marked, in vitro diagnostic real-time PCR test 
kit for the qualitative detection of SEPT9 gene methylation (mSEPT9) 
in cell-free bisulfite converted DNA isolated from human plasma 
samples. Presence of mSEPT9 is associated with, and may aid in, the 
detection of invasive colorectal adenocarcinoma.
The mSEPT9 assay is based on detecting aberrant DNA methylation of 
the v2 region of the Septin9 gene. Cytosine residues in the v2 region
become methylated in colorectal cancer tissue but not in normal colon
mucosa. This aberrant methylation can be detected by specific 
amplification of DNA shed into the blood stream by tumor cells. 
Detection of colorectal cancer DNA using the mSEPT9 biomarker has 
been demonstrated in multiple case control studies with plasma 
specimens from colorectal cancer patients and colonoscopy-verified 
negative controls to be a strong indicator of the presence of 
colorectal cancer.
For more information on Epi proColon test and its availability in 
Europe visit HYPERLINK 
"http://www.epiprocolon.com"www.epiprocolon.com or contact 
Epigenomics directly by Email  (HYPERLINK "mailto:sales@products.epig
enomics.com"sales@products.epigenomics.com) or phone (+49 30 24345 
111).
Epi proColon is not for sale in the United States of America.
About Epigenomics
Epigenomics is a molecular diagnostics company with a focus on the 
development of novel products for cancer. Using DNA methylation 
biomarkers, Epigenomics' tests on the market and in development aim 
at diagnosing cancer at an early stage before symptoms occur and 
thereby may reduce mortality from this dreaded disease.
Epigenomics' product portfolio contains Epi proColon, a CE-marked IVD
blood test for the early detection of colorectal cancer based on the 
validated biomarker mSEPT9, and further proprietary DNA methylation 
biomarkers at various stages of development for colorectal, prostate 
and lung cancer detection in urine, blood and bronchial lavage 
specimens. Epigenomics' biomarker mSEPT9 for the early detection of 
colorectal cancer in a simple blood sample has demonstrated 
continuously highest performance in eight clinical case-control 
studies with in total more than 3,250 individuals tested. A large 
prospective clinical study - PRESEPT - to evaluate the performance 
characteristics and the health economic benefit of colorectal cancer 
screening with the mSEPT9 biomarker in a representative screening 
population currently under way (www.presept.net). Once completed, the
PRESEPT Study will be one of the largest commercially sponsored 
colorectal cancer screening clinical studies ever conducted. The 
clinical performance and health economic analysis results are 
expected to support future coverage of mSEPT9 testing by public and 
private health insurers worldwide. Epigenomics' partners developing 
IVD test kits for the mSEPT9 biomarker can co-fund and access the 
PRESEPT sample collection to conduct clinical trials for regulatory 
filings in the U.S.
For development and global commercialization of IVD test products, 
Epigenomics pursues a dual business strategy in which direct 
commercialization of proprietary diagnostic test products is combined
with non-exclusive licensing to diagnostic industry players with 
broad customer access. Strategic diagnostics industry partners 
include Abbott Molecular, Philips, Sysmex Corporation, Quest 
Diagnostics Incorporated, and ARUP Laboratories, Inc. for diagnostics
test products and services, and QIAGEN N.V. for sample preparation 
solutions and research products.
Partners in the health care industry and the biomedical research 
community can access Epigenomics' portfolio of proprietary DNA 
methylation technologies and biomarkers through research products, 
Biomarker Services, IVD Development Collaborations, and Licensing. 
The company is headquartered in Berlin, Germany, and has a wholly 
owned subsidiary in Seattle, WA, U.S.A. For more information, please 
visit Epigenomics' website at HYPERLINK 
"http://www.epigenomics.com"www.epigenomics.com.
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 in the 
United States. The analytical and clinical performance 
characteristics of any product based on this technology which may be 
sold at some future time in the U.S. have not been established.

Further inquiry note:

Epigenomics AG
Dr. Achim Plum
Sen. VP Corporate Development
Tel: +49 30 24345 368
achim.plum@epigenomics.com

Branche: Biotechnology
ISIN: DE000A0BVT96
WKN: A0BVT9
Index: Prime All Share, Technologie All Share
Börsen: Frankfurt / regulated dealing/prime standard
Berlin / free trade
Hamburg / free trade
Stuttgart / free trade
Düsseldorf / free trade
München / free trade

Plus de actualités: Epigenomics AG
Plus de actualités: Epigenomics AG