”We are excited to be the first laboratory to work with the mSEPT9 test. This test is a true innovation in early cancer detection”, commented Edouard H. Viollier, MD, chairman, board of directors Viollier AG. “Blood sampling is easy and convenient for both the patient and the doctor and this test is performed in our professional laboratory under highest quality standards that ensure reliable results. We believe that this could be the future of non-invasive colorectal cancer screening and key to increasing compliance to screening programs.”
The majority of colorectal cancers are diagnosed in advanced stages, limiting the chances for curative treatment. To improve prognosis for this disease the cancer must be detected in early stages. More than 90% of all patients could be cured if the cancer was diagnosed at an early, still localized stage.
“Compliance is the biggest hurdle in colorectal cancer screening. Although there are procedures like colonoscopy and FOBT that have been established as screening modalities for several years now, there still is very little acceptance and poor compliance by the patients”, Prof. Peter Bauerfeind, of the Division of Gastroenterology & Hepatology of the University Hospital Zurich, Switzerland, commented the launch of the test. “A blood-based test fits into doctors’ daily routine and requires almost no patient involvement. Such a test for colorectal cancer screening could find much better acceptance among patients and drive compliance.”
The mSEPT9 colorectal cancer blood test is designed to be as convenient and patient friendly as possible. All it takes for the patient is giving a blood sample in the doctor’s office as part of their regular check-up. The sample is shipped to a local or regional diagnostic laboratory where it is tested for the mSEPT9 biomarker. The test result is provided to the doctor who can discuss it with the patient within a few days after the blood sample was taken. If the test were positive, a colonoscopy would typically be performed to confirm the test result and localize the tumor as a first step towards cancer therapy.
Epigenomics has shown in a series of seven published case control studies with over 3,000 patient-samples and controls, that the mSEPT9 assay reliably detects cell–free DNA derived from colorectal tumors in blood samples and thereby indicates the presence of colorectal cancer of all stages.
Epigenomics expects further diagnostic laboratories in Europe to introduce mSEPT9 testing in due course. In addition, Epigenomics’ non-exclusively licenses the mSEPT9 biomarker and its technologies to partners in the diagnostics industry for global commercialization of in vitro diagnostic blood tests for colorectal cancer based on mSEPT9. A first IVD test kit for mSEPT9 testing is expected to be launched in Europe by the end of 2009. In the US, mSEPT9 testing is expected to be offered initially by Quest Diagnostics, a leader in diagnostic testing, information and services in the US Quest Diagnostics is currently in the process of establishing a laboratory-developed test for mSEPT9 under license from Epigenomics. FDA approved IVD products through Epigenomics’ current and future IVD partners will follow.
