Tous Actualités
Suivre
Abonner Epigenomics AG

Epigenomics AG

EANS-News: Epigenomics AG Reports Conclusions from PRESEPT Study Audit

Differences in analytical instrument read-out requires verification 
and potential retesting of samples measured in laboratory with 
deviating results
Top-line data expected still in Q1 2010
No
impact on commercial strategy expected
  Corporate news transmitted by euro adhoc. The issuer/originator is solely
  responsible for the content of this announcement.
Research & Development/Molecular Diagnostics/Products
Subtitle: Differences in analytical instrument read-out requires 
verification and potential retesting of samples measured in 
laboratory with deviating results
Top-line data expected still in Q1 2010
No impact on commercial strategy expected
Press release, Berlin, Germany, and Seattle, WA, U.S.A., February 4, 
2010 (euro adhoc) - Epigenomics AG (Frankfurt, Prime Standard: ECX), 
a cancer molecular diagnostics company, today reported the 
conclusions from the investigation into the results from one of the 
three laboratories that were used to test samples of the PRESEPT 
Study cohort.
The investigation had been initiated by the Clinical Study Steering 
Committee (CSSC) following the reporting of preliminary results of 
the PRESEPT Study on January 15, 2010. These preliminary findings 
indicated that in two of the three testing laboratories that 
performed Septin9 testing on blood plasma samples from the PRESEPT 
Study, subjects achieved cancer detection rates of 62.5% each and 
therefore were well within expectations. The third laboratory 
reported a cancer detection rate of 28% which deviated from the 
findings in the other testing laboratories and all previous eight 
case control studies on the biomarker that in total included more 
than 3,300 plasma samples from cancer patients and control subjects. 
(Refs 1-3)
The thorough audits of the testing laboratories revealed that the 
analytical instrument used in the laboratory with the divergent 
results was a recently released new version of the device that was 
unique to this study laboratory. In the other two laboratories, a 
different instrument version was used. The audit team observed that 
the instrument which generated the lower than expected cancer 
detection rate reported unusually high fluorescence signals in 
several runs which could have impacted the read-out of results. Those
signals could originate from the sample containers used on that 
device and/or the device itself. This observation was not made in any
of the two other laboratories nor any previous study by Epigenomics. 
The audits at all three testing laboratories, Epigenomics' internal 
processes as well as the biostatistics group at the University of 
Minnesota performed as part of the investigation did not identify 
significant deviations related to sample traceability, sample 
handling, or sample processing which could explain the observed 
results.
Epigenomics will verify the cause for the observed high fluorescent 
signals and generate data to demonstrate whether and how far this 
could be responsible for the results observed in the lower cancer 
detection rate. If necessary, the company will retest study subject 
samples that were potentially affected by this incident.
In addition to the further investigation into the lower cancer 
detection rate in the one laboratory and following the 
recommendations of the CSSC, a small number of additional cancer 
cases will be tested. These cancer cases were confirmed by pathology 
after shipping the last testing batches to the laboratories in 
December. The CSSC had stipulated the testing of these samples in the
original study plan to include the results in the final data set to 
be submitted to a peer-reviewed scientific journal for publication. 
The company still expects that all further testing and retesting of 
samples can be completed within Q1 2010. The company plans to release
the updated top-line results from the study including the additional 
and repeated testing results once they become available.
"We are fully on track in executing on the commercialization of our 
already launched colorectal cancer blood test, the Epi proColon 
product", commented Geert Nygaard, Chief Executive Officer of 
Epigenomics. "It is important to realize that the PRESEPT Study is an
academic medicine study. Its results remain entirely independent of 
the regulatory pathway such as future FDA approvals and clearances of
our Epi proColon product, Abbott's mS9 assay, or Quest's ColoVantage 
test in any current or future market." Further information
Conference Calls
Epigenomics' management has scheduled a conference call for today, 
February 04, 2010 at 14:00 CET (German language) and 17:00 CET/11:00 
am EST (English language) to update on findings in the investigation 
of outlier results in the PRESEPT Study and planned corrective 
actions as well as answering questions from investors and media. The 
dial-in numbers for the conference call are:
Dial-in number (within Germany): +49 (0)69 247 501 899
Dial-in number (within US): +1 212 444 0297
Participants are kindly requested to dial in 10 minutes prior to the 
start of the call.
A recording of the conference call will be provided on Epigenomics' 
website subsequently: {http://www.epigenomics.com/en/down_loads/corpo
rate_material/}[HYPERLINK: 
http://www.epigenomics.com/en/down_loads/corporate_material/]
References
1. Lofton-Day C, et al. DNA methylation biomarkers for blood-based 
colorectal cancer screening. Clin Chem. 2008;54(2):414-23. 2. 
Grützmann R, et al. Sensitive detection of colorectal cancer in 
peripheral blood by mSEPT9 DNA methylation assay. PLoS One. 
2008;3(11):e3759. 3. deVos T, et al. Circulating methylated SEPT9 DNA
in plasma is a biomarker for colorectal cancer. Clin Chem. 
2009;55(7):1337-46.
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 the CE-marked IVD test Epi 
proColon®, the world's first regulatory cleared molecular diagnostic 
test for the detection of colorectal cancer in blood that is based on
the biomarker Septin9, and further proprietary DNA methylation 
biomarkers and IVD products at various stages of development for 
colorectal, lung and prostate cancer. 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. 
The company is headquartered in Berlin, Germany, and has a wholly 
owned subsidiary, Epigenomics Inc., in Seattle, WA, U.S.A. For more 
information, please visit Epigenomics' website at 
{www.epigenomics.com}[HYPERLINK: http://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.
end of announcement                               euro adhoc

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, Technology 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