Life Technologies is to supply Epigenomics with its Dynabeads® MyOne™ Silane and buffers as an integral component of latter’s second-generation Epi proColon® 2.0 colorectal cancer blood test, which is currently in development for the U.S. and EU in vitro diagnostics (IVD) markets. Epigenomics claims the new version of the test will require fewer components and handling steps than the first-generation assay, generate results within eight hours, and be easier to automate on a range of IVD platforms.
Epi proColon is designed to detect methylation of the Sept9 gene as a biomarker for early colon cancer diagnosis. The new version of the IVD will exploit Life Technologies’ DNA-binding magnetic beads for binding and separating out the target DNA. Epigenomics says analytical and clinical validation studies with the test will be carried out during the second half of 2011, and a PMA could be filed with FDA before the end of the year. Launch of the test as a CE-marked IVD is also projected during 2011.
"Securing access to Life Technologies' magnetic beads and reagents for our second-generation Septin9 test has been very improtant for the development of Epi proColon 2.0," comments Uwe Staub, Ph.D., svp product development at Epigenomics. "By including these critical components into our assay along with some other modifications, we were able to significantly improve clinical performance and shorten the overal time to result, allowing for testing of higher volumes of samples."
The firm claims a feasibility study involving 97 colorectal cancer cases and 159 colonoscopy-confirmed controls found Epi proColon 2.0 demonstrated a sensitivity of 91% and specificity of 87%. The test identified 21 of 27 stage I cancer cases, all 25 stage II cases, 92% of stage III cases, and every stage IV patient. Epigenomics points out the ability to correctly identify stage I and II cancers is particularly important for ensuring treatment is started early to improve survival.
In February Qiagen negotiated an option to take out a worldwide, nonexclusive, commercial license to Epigenomics’ mSEPT9 biomarker and DNA methylation technologies for the detection of colorectal cancer in blood. The option can be exercised by Qiagen within the next two years. As part of the collaboration agreement Epigenomics in addition granted Qiagen a research license to the mSEPT9 biomarker and the technologies, which will enable Qiagen to develop a sample-preparation technology for the potential future implementation of methylation-based molecular diagnostics on its QIAsymphony testing platform.