Originally Published IVD Technology June 2003
INDUSTRY NEWS
Tests for colorectal cancer being developedColorectal cancer is the second-highest cause of cancer-related death in the U.S. The National Colorectal Cancer Research Alliance estimates that this year nearly 131,000 new cases will be diagnosed, and about 56,000 people will die from this disease. However, more than 90% of colorectal cancer cases are curable when diagnosed in their earliest stages. Two recent developments could give rise to effective diagnostic tests for colorectal cancer.
Roche Diagnostics (Basel, Switzerland) and Epigenomics AG (Berlin) signed a three-year agreement to develop a range of molecular diagnostic and pharmacogenomic cancer products based on Epigenomics' DNA methylation technologies. Under the terms of this agreement, Roche will make an upfront payment of about $4.2 million. Roche will also provide research and development funding, milestone payments, and royalties on product sales. Both companies estimated that the total value of the agreement could exceed $106 million.
Roche and Epigenomics officials said the two companies will collaborate to develop diagnostics products for use in the early detection of cancers at major sites, their characterization, and the prediction of treatment response to particular anticancer drugs. Epigenomics will oversee the efforts in marker discovery, identification, and prevalidation. Roche will be responsible for diagnostic test development, clinical trials, product manufacturing, regulatory submissions, and all worldwide sales and marketing.
This collaboration could lead to the development of a test for colorectal cancer. Epigenomics reached a licensing agreement with Johns Hopkins University (Baltimore) for an at-risk marker for colon cancer. Research has shown that detecting the marker is 20 times more likely in patients with a history of colorectal cancer, and five times more likely in patients with a family history of colorectal cancer. Epigenomics and Johns Hopkins University intend to research the marker further and develop a test to detect its presence using Epigenomics' DNA methylation technologies.
"We hope that by developing a DNA-methylation-based test to indicate the predisposition of individuals to [colorectal cancer], people at risk will regularly participate in screenings and seek treatment in sufficient time, if a diagnosis is made," said Kurt Berlin, chief scientific officer at Epigenomics.
In addition, ScheBo-Biotech AG (Giessen, Germany) has developed a test for the early diagnosis of colorectal cancer. According to company officials, an important element of this test is a procedure for detecting tumor M2-PK, an enzyme for the regulation of tumor metabolism, in stool samples. Even at an early stage, it is possible to track down these enzymes with this new method. This test can also recognize precancerous stages of colorectal cancer, so called adenomas, after they have reached a certain size.
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