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
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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 “
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