BERLIN & NEWARK, Calif.—Epigenomics AG, the German-American cancer molecular diagnostics company, and BioChain Institute Inc., a leading clinical diagnostics company in cancer and genetic tests in China and the United States, announced that BioChain has completed its major clinical study to validate Epigenomics’ blood-based Septin9 screening assay Epi proColon for the early detection of colorectal cancer (CRC) with the goal of gaining market approval for the test in China. In addition, BioChain officially submitted an application to the China Food and Drug Administration (CFDA) in April for the approval of Epi proColon. Both companies expect commercialization of the test in China to start in 2015.
“The availability of the blood assay in China, pending CFDA approval, is huge,” Noel Doheny, CEO of Epigenomics’ U.S. subsidiary, tells DDNews. “China has 290 million eligible patients for CRC screening. Increasing rates of cancer are a huge cost burden for the country. Early detection and intervention may address this challenge. We are very pleased with the study and the data.”
Moreover, in a report published in December 2013, the independent market research firm Decision Resources estimates that the number of incident cases of CRC in urban areas of China will almost double between 2012 and 2022. The Chinese government has elected CRC screening as one of its key focus areas in cancer prevention.
The clinical validation study was designed to evaluate the performance of Epi proColon for the detection of CRC and is part of the required data package to seek regulatory approval in China. From November 2013 to March 2014, a total of 1,074 patients at three top-ranking hospitals in China were tested by using Epigenomics’ Epi proColon 2.0 CE assay. The blood-based test detected 74.8 percent of the cancer cases (sensitivity) and correctly identified 97.4 percent of the patients free of disease (specificity). The tested study cohort included 300 cancer cases in stages I to IV. The results were marked as positive when at least two out of three samples of the test triplicate were evaluated as positive.
The results were in line with those achieved in Epigenomics’ European CE marking study reported in 2011, which followed the same principle of data interpretation (80 percent sensitivity and 99 percent specificity).
“We are excited about the excellent performance of Epi proColon in this clinical trial,” said Grace Tian, CEO of BioChain, in the news release about the test’s progress. “These results and the filing for regulatory approval with the CFDA are significant milestones towards commercialization of this sophisticated cancer screening test in the Chinese market. We strongly believe that the convenience and the simplicity of the blood-based Epi proColon test will pave the way to significantly improve CRC screening in China.”
Dr. Thomas Taapken, CEO and CFO of Epigenomics, added: “We are thrilled that BioChain completed this clinical study sooner than anticipated, which expresses their strong commitment and enthusiasm to bring our test into the Chinese market. CRC has a very good prognosis if detected at an early stage. Regular screening for cancer, therefore, is highly desirable.”
In March 2013, BioChain licensed Epigenomics’ methylated Septin9 marker for the blood-based detection of CRC. The collaboration was significantly expanded in October 2013 when BioChain acquired an exclusive license to develop and commercialize Septin9 IVD for CRC screening in the Chinese market and took a stake in the company.
The companies are also working together on the validation of other methylation biomarkers in the cancer field. Epigenomics owns intellectual property around a variety of cancer diagnostic markers for lung, prostate and bladder cancer as well as for other solid tumors and markets a CE-marked product for lung cancer diagnosis based on its proprietary SHOX2 biomarker. Should the companies develop any future products, BioChain will have the option to acquire commercialization rights for the Chinese market, while Epigenomics will retain rights for the rest of the World.
In related news, Epigenomics announced the outcome of a meeting of the Molecular and Clinical Genetics Panel of the U.S. Food and Drug Administration's (FDA) Medical Devices Advisory Committee held in conjunction with its premarket approval for Epi proColon. The members of the committee voted positively that the benefits of Epi proColon outweigh the risks for use in patients who meet the criteria.
The Advisory Committee members also voted nine to zero favorably, with one abstention, in assessing whether there is reasonable assurance for safe use of the product in the intended population. The committee members were split five to five in the vote assessing the effectiveness for use of the product in the intended population, with a negative vote from the panel chairperson to break the tie.
“The panel’s concerns with respect to efficacy were centered on programmatic test performance (use in multiple years with cumulative detection performance),” notes Doheny. “These studies are never done pre-approval,” he adds, but are planned for the near-future.
Finally, the panel voted five to four favorably, with one abstention, on the question of whether for patients who meet the criteria specified in the proposed intended use, the benefits outweigh the risks for use of Epi proColon. While recommendations of the Advisory Committee are not binding, they will be considered in FDA’s review process.