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GEN News Highlights : Jun 19, 2012

Companion Dx Negotiates License to Epigenomics’ Septin9 Blood Biomarker for CRC Test

Nonexclusive license will allow development of laboratory-developed test for colorectal cancer.

Companion Dx negotiated a nonexclusive license to Epigenomics’ DNA methylation biomarker Septin9 for use in the development and commercialization of a blood-based laboratory-developed test for detecting colorectal cancer. Under terms of the deal Epigenomics will receive double-digit royalties on future sales of the test.

Companion Dx is a molecular diagnostic reference laboratory offering pharmacogenomic assays and cancer companion diagnostics. The firm is sited at the Universit of Texas Health Science Center’s Biotechnology Commercialization Center.

Epigenomics already has laboratory-developed test agreements for Septin9-based colorectal cancer blood tests in place with Quest Diagnostics, Arup Laboratories, and Warnex Medical Laboratories in North America. Abbott Molecular holds a worldwide, nonexclusive license to develop and commercialize IVD test kit products, and both Qiagen and Sysmex retain options for nonexclusive worldwide licenses. The firm says over 26,000 Septin9 tests were carried out in 2011 by its licensees.

In addition to granting nonexclusive licenses to the biomarker and DNA methylation technologies to the diagnostics industry, Epigenomics is directly commercializing the test under its own Epi proColon® brand. The screening test is already approved in Europe and is being progressed through the U.S. regulatory system.

Just last week Epigenomics submitted to FDA the third of four modules that will make up the complete Premarket Approval submission for Epi proColon. Module three described the analytical performance of Epi proColon in terms of accuracy, precision, and stability. The fourth module, due for submission during the second half of 2012, will include the results of a head-to-head comparative study with the goal of demonstrating noninferiority of Epi proColon to fecal immunochemical testing.