Company will use the DNA methylation marker to develop a lab diagnostic and prognostic.

Epigenomics granted Predictive Biosciences a nonexclusive license to use its prostate cancer DNA methylation biomarker, mGSTP1, for the development and commercialization of a laboratory test to help in the diagnosis and management of prostate cancer. The agreement follows a similar deal covering mGSTP1 signed with Quest Diagnostics in February 2009.

Established some 10 years ago, Epigenomics is focused on exploiting DNA methylation biomarkers for the development of body fluid or tissue-based cancer diagnostic and prognostic tests. The company’s lead product, a colorectal cancer early-detection test based on the biomarker, mSEPT9, is scheduled for launch in Europe toward the end of 2009 by partner, Abbott, which also aims to file for approval in the US.

Quest Diagnostic is also developing a mSEPT9 colorectal cancer laboratory-validated assay under license from Epigenomics and is due to launch its mSEPT9 testing service “in due course,” according to Achim Plum, Ph.D., svp corporate development at Epigenomics. In Japan, the company is working with Sysmex to introduce the mSEPT9 test.    

In addition to its lead colorectal cancer program and its partnered prostate cancer projects, Epigenomics is developing a confirmatory test for lung cancer. “Epigenomics itself aims to launch a confirmatory test for lung cancer in Europe during the first half of 2010,“ Dr. Plum says. “Based on our proprietary biomarkers, the test carried out on bronchial lavage samples will clarify lung cancer diagnosis in cases when the results from cytology are inconclusive.  And because the biomarkers are very specific, this test should give a very high positive predictive value, significantly boosting the accuracy of diagnosis. ”
The company will also be making a new prostate cancer prognostic test available on an early access program during 2009. “In development for testing post-prostatectomy patient samples, the test determines the methylation status of the PITX2 gene. If methylation of the gene is low, the prognosis is good in terms of risk of PSA relapse. If PITX2 is highly methylated, the prognosis is may not be so good. ”

Epigenomics’s eventual goal is to establish its DNA methylation biomarkers in colorectal, lung, and prostate cancer as cancer screening tests.“Rather than just providing an indication of predisposition for a disease, DNA methylation can detect the presence of a disease using easily obtainable samples  even at the presymptomatic stage and so is ideally suited to wide-spread screening programs,” points out Dr. Plum.

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