Epigenomics has developed and launched two CE marked IVD products based on methylation biomarkers:
Epi proColon - a test to measure the methylation status of the SEPT9 promoter in plasma as an aid in early detection of colon cancer.
Epi proLung - a test to measure the methylation status of the SHOX2 gene in bronchial lavage fluid, to help in the workup of patients suspect to have lung cancer.
These products are not currently available in the U.S.
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Epigenomics has licensed the SEPT9 biomarker and certain DNA methylation technologies to Quest Diagnostics and ARUP Laboratories in the US, as well as Warnex Laboratories in Canada. These labs have independently launched Laboratory Developed Tests for the SEPT9 biomarker, and are providing this SEPT9 testing service to the medical community in the US and Canada. Although these tests were developed independently by the licensees and Epigenomics therefore cannot guarantee their performance, the results of clinical validations by these companies are very similar to those obtained by Epigenomics. Epigenomics also has a strategic partnership with Abbott Molecular for the development of an IVD test kit based on the SEPT9 biomarker. Abbott has launched this test as a CE marked IVD in Europe under the brand name mS9.
