CE-marked test kit detects methylated DNA of SEPT9 in blood plasma.
Epigenomics and Dateks agreed to a distribution deal for Epigenomics’ Epi proColon test in Turkey. Epi proColon is a CE-marked test kit for the detection of methylated DNA of the Septin9 gene (SEPT9) in blood plasma. The company expects to submit a marketing application to the FDA during 2011.
The Septin9 biomarker has been shown in clinical studies to be associated with the presence of colorectal cancer and may aid in its detection. Normally, SEPT9 provides instructions for producing septin-9, which is part of a group of proteins involved in cytokinesis and also appears to act as a tumor suppressor.
Alterations to the expression of SEPT9 are believed to be associated with certain cancers. Additionally, the altered gene expression may enhance cancer-related events such as cell proliferation and angiogenesis.
Despite establishing Cancer Early Diagnosis and Screening Centers in most provinces and the introduction of colorectal cancer screening standards by the Turkish Ministry of Health, actual screening participation is still low, according to the companies. This has severe consequences as colorectal cancer is highly curable when detected at an early, localized stage.
“Epi proColon facilitates the early detection of colorectal cancer, making screening easier and more patient-friendly than ever,” Süha Dere, CEO of Datek explains. “As a blood test, it is a simple and clean solution for the patients.
“Importantly, it can be performed at any time as it does not require any preparation of the screened individual. We believe that this test can help significantly to drive acceptance of colorectal cancer early detection in the Turkish population.”
Epigenomics markets Epi proColon in Austria, Germany, and Switzerland. The product is marketed by Pronto Diagnostics in Israel. NextPharma Technologies has a global contract for the commercial manufacture of Epi proColon.