Experiences with the Septin9 test
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Information for Domestic U.S. customers
I acknowledge that Epigenomics currently does not sell or make available the Septin9 test Epi proColon in the U.S. While a Septin9 biomarker colorectal cancer diagnostic test is available from Epigenomics in Europe, Epigenomics currently does not sell or make available any such test in either Canada or the USA. Epigenomics is in the process of seeking regulatory approval/ clearance for these markets, so please check back at our site for the latest developments.
Epigenomics has licensed its Septin9 colorectal cancer biomarker and methylation technology to a number of clinical laboratories, more particularly, Warnex in Canada and Quest Laboratory and ARUP in the USA.
Epigenomics understands that each of these clinical laboratories has chosen, independent of any participation by Epigenomics, to develop, validate, and market a diagnostic testing service using the Septin9 biomarker and associated technology. Such services are only available by request from a physician.
Because Epigenomics was not involved in the development of and in no way supports these Septin9 laboratory testing services, it cannot provide a guarantee or validation with regard to the analytical and clinical performance characteristics of such independent Septin9 testing services.