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