Date: 2011-09-19
Type of information:
phase: validation study
Announcement: results
Company: Epigenomics (Germany-USA)
Product: Epi proColon® 2.0 (colorectal cancer blood test)
Action mechanism:
Disease: colorectal cancer detection
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On December 9, 2011, Epigenomics has reported the completion of the clinical validation study for its second-generation colorectal cancer blood test Epi proColon in the U.S. The study was designed to measure the clinical performance of Epi proColon for the detection of colorectal cancer in comparison to colonoscopy and is part of the required data package to seek regulatory approval of the product in the U.S. In the reported study, Epi proColon detected 68% of the colorectal cancer cases (sensitivity) while correctly identifying 80% of the patients free of disease (specificity). While the results of the study represent the lower end of the expected performance data, the findings of the study confirm the results obtained in a previously conducted clinical study with the first generation of the company’s Epi proColon test in the same cohort of patients.
After consultation with the FDA, Epigenomics confirmed that the clinical data would be assessed as part of the regular Premarket Approval (PMA) review process. The Company will begin the regulatory process with the FDA by submitting the first module of its PMA this month. In addition to the clinical validation study data, Epigenomics will also perform a head-to-head comparative study for colorectal cancer detection through comparison with fecal immunochemical testing (FIT) for the purpose of demonstrating non-inferiority of Epi proColon to FIT. This study will also become an integral part of the PMA submission to the FDA and is anticipated to be completed in 2012.
* On September 19, 2011, Epigenomics has reported positive results in a clinical study for its second generation blood-based test for the early detection of colorectal cancer, Epi proColon® 2.0. In the study, 98 patients with colorectal cancer and 149 patients with no evidence of disease as verified by colonoscopy were tested with the Epi proColon® 2.0 test. The test identified 95% of the cancer cases (i.e. 95% sensitivity) at a specificity of 85%. Most importantly, for stage I and II cancer where therapeutic interventions have the greatest likelihood of curing the patient from the disease, the combined sensitivity was 91%. These results demonstrate a very significant improvement over the performance of the first generation Epi proColon® test, currently marketed in Europe. In the product validation study conducted with this product in 2009, 67% of the cancer cases were detected at comparable specificity.
The new study is the first of two studies by Epigenomics to clinically validate the newly developed test. It provides the clinical evidence required for CE-marking of Epi proColon® 2.0 for launch in the European market later this year. Further, it paves the way for the second validation study that is required for a submission of the test to the FDA. This pivotal clinical trial will be conducted at three external laboratories, which will test a subset of blood samples from a prospectively collected cohort of about 8,000 subjects. The study is expected to be initiated and completed in time for a submission to FDA before year-end 2011.
