Biochip for colorectal cancer screening in serum

Crumlin, UK (February 29, 2008)

Randox Laboratories GmbH is collaborating with the University of Lübeck, the Jena University Hospital, and the German Cancer Research Centre Heidelberg (DKFZ) in a partnership to develop a new colorectal cancer screening test.

Colorectal cancer is the second most common cause of cancer mortality in the Western world and around 70,000 new cases are diagnosed in Germany every year. Despite the availability of colorectal cancer screening methods such as faecal occult blood testing and colonoscopy, around 70% of cases have already reached an advanced stage at the time of diagnosis.

Colorectal cancer can be surgically treated by removing pre-cancerous lesions, small colorectal cancer tumours and even entire sections of the colon. Other options for treatment are radiotherapy, chemotherapy and monoclonal antibody therapy. In many cases, one or more of these methods can effect a cure, but only if the cancer is detected at a sufficiently early stage. Therefore effective colorectal cancer screening has the potential to dramatically improve prognosis and survival rates.

Existing methods for population screening for colorectal cancer, such as faecal occult blood (FOB) testing and colonoscopy, have their limitations. FOB testing has been proven to improve colorectal cancer detection and reduce colorectal cancer mortality. Nevertheless, FOB testing is relatively non-specific, when compared to colonoscopy for example, and suffers from both false-positives and false-negatives. Colonoscopy is an excellent screening method for colorectal cancer, with the added advantage that tissue biopsies can be taken and small lesions and polyps can be removed during the procedure. However, colonoscopy requires patient bowel preparation and an invasive procedure.

The ideal colorectal-cancer screening method would be a sensitive yet simple-to-perform non-invasive test for colorectal cancer-specific markers in the blood. This would greatly simplify the provision of a national population-based colorectal cancer screening programme that is both effective and cost-effective. A number of individual markers have shown promising results in colorectal cancer detection. The partnership is taking the novel approach of using 12 markers in combination to achieve optimal sensitivity and specificity in colorectal cancer screening and diagnosis. The partnership is engaged in a collaborative investigative study to develop, test and validate a colorectal cancer screening biochip for the simultaneous detection of a panel of colorectal-cancer specific serum markers. It is hoped that this multi-marker approach will be able to improve the early detection of colorectal cancer through population screening, and thus lower the burden of this common disease.

In summary, it is possible to dramatically reduce both the mortality and the incidence of colorectal cancer through effective population screening methods. Population screening has been shown to detect colorectal cancer at an earlier stage, often before symptoms appear. The partnership is collaborating in the development of a colorectal cancer screening biochip that uses a multi-marker approach to improve the detection of colorectal cancer-specific markers in the blood.

The project is generously funded by the Federal Ministry of Education and Research (BMBF). The BMBF provides funding for research projects and institutions within Germany.

About the University of Lübeck
The University of Lübeck was founded as the Medical Academy Lübeck in 1964 and it is characterised by outstanding translational cancer research and academic teaching. The University with its Laboratory for Surgical Research, Dept. of Surgery, is responsible for coordinating the study, clinical validation of the diagnostic biochip serum assay and transferring the biochip assay into clinical practice.

About the Jena University Hospital at the Friedrich Schiller University (FSU)
The Friedrich Schiller University is located within the university city of Jena in central Germany. FSU Jena celebrates its 450th anniversary in 2008. The Jena University Hospital with its Core Unit Chip Application (CUCA) is responsible for clinical validation of the diagnostic biochip serum assay and transferring the biochip assay into clinical practice.

About Deutsches Krebsforschungszentrum (DKFZ) Heidelberg
The German Cancer Research Centre in Heidelberg is dedicated to the systematic investigation of the mechanisms of cancer development and the identification of risk factors in order to develop new approaches for the prevention, diagnosis and treatment of cancer. The Centre with its Division of Clinical Epidemiology and Aging Research is responsible for supplying clinical samples and data from a large colorectal cancer screening population, statistical evaluation and validation of the biochip assay.

About Randox Laboratories GmbH
Randox is an international diagnostics company that develops, manufactures and markets clinical diagnostic products worldwide. Randox is the industry partner in the consortium and is responsible for the development of the diagnostic biochip serum assay for colorectal cancer screening. Randox has developed and manufactures a stool-based DNA screening biochip for colorectal cancer.