Our cancer specialty tests are intended for people at high risk of developing cancer or at patients newly diagnosed with cancer and are either based on body fluids or tumor tissue. They address areas with - in our opinion - high medical need such as recurrence monitoring or cancer prognosis. We currently have two cancer specialty diagnostic tests in research and development: a colorectal cancer surveillance test and a prostate cancer molecular classification test.


Characteristics and Market Potentials of Cancer Specialty Diagnostics

Our colorectal cancer surveillance test aims at the surveillance or monitoring of patients at high risk of developing colorectal cancer or experiencing cancer recurrence. The test will be based on our proprietary biomarker Septin 9 and potentially other proprietary biomarkers.

In our studies on 3,000 colorectal cancer patients and controls we have already demonstrated that our biomarkers may be tuned for cancer detection rates of 70% or more in blood. Further we demonstrated in a smaller clinical study in 2006 that included samples from patients with colon polyps, precancerous lesions that have a high likelihood of progressing to colorectal cancer, that Septin 9 in combination with another DNA methylation biomarker (ALX4), can reliably detect the presence of colorectal polyps.

In 2007 we have been preparing initial clinical studies to establish our colorectal markers for surveillance applications such as monitoring of patients with a personal history of colorectal cancer for relapse. This patient group consists of about 500,000 individuals in the U.S. alone who have undergone surgery following the diagnosis of colorectal cancer and require regular surveillance up to several times a year. The potential annual size of this niche market in the U.S. is over €30 million assuming annual testing and similar compliance and pricing as our colorectal cancer screening test. We intend to make these biomarkers available to patients and gastroenterologists through centralized reference laboratories in 2008*.

* Current Epigenomics management estimate for earliest possible launch.

Our prognostic cancer molecular classification test in prostate cancer targets prostate cancer patients that undergo radical prostatectomy, i. e. in our estimate approximately 150,000 patients p. a. in the U.S., Europe and Japan.

The test is based on our proprietary biomarker PITX2 which was validated as a prognostic biomarker for prostate cancer in a study conducted in 2005 on 605 paraffin-embedded prostate cancer samples. The DNA methylation of this biomarker indicates the risk of relapse for the individual patient after the primary tumor has been removed by a radical prostatectomy. Further, the biomarker PITX2 can add significant information to established prognostic clinical parameters such as tumor size, Gleason Score (a score assigned by the pathologist based on the microscopic appearance of the tumor tissue) and pre-surgery PSA levels and thus may help to better predict which patients will eventually relapse. This could help patients and doctors to decide on appropriate follow-up procedures after prostatectomy.

How will our future prostate cancer molecular classification test be applied?
Unlike cancer screening tests, the test will be performed on tissues from surgical tumor samples that are routinely processed for microscopic evaluation by the pathologist. Using these samples, it aims at gaining further information on the prognosis. In diagnostic laboratories DNA will be extracted from the tumor sample and prepared for DNA methylation analysis using solutions to be developed by our partner Qiagen. Our proprietary DNA methylation biomarkers will be measured using our test kit on instrumentation to be provided by our partner Affymetrix. With the result at hand, the oncologist together with the patient may decide on the best way forward.

For this tissue test we have access to key reagents and devices of an IVD platform through collaboration agreements with Qiagen GmbH and Affymetrix, Inc.. Qiagen is also our preferred partner to develop an IVD compatible pre-analytics solution for DNA methylation based tests. Through our strategic diagnostics platform agreement with Affymetrix we have access to their entire installed base of IVD instruments and their microarray technology. In late 2006 we successfully transferred our lead biomarker for prostate cancer prognosis PITX2 onto the Affymetrix platform. This clears the way for the development of the final test workflow.

After the launch of the test in a reference laboratory expected in 2008*, we intend to further pursue the development of a CE-marked kit for product launch in Europe. We estimate the peak market potential for a prostate cancer molecular classification test that adds prognostic information where current clinical and pathological parameters fall short to be in the € 30 million range in the major markets (U.S., Europe and Japan).

* Current Epigenomics management estimate for earliest possible launch.

These products are not available for sale in the United States. The analytical and performance characteristics of any product to be eventually sold in the U.S. based on this technology have not been established.