Colorectal Cancer

Epi proColon Early Detection AssayWe currently market the second generation of our Epi proColon® colorectal cancer early detection assay in Europe both directly and through distribution partners. At the same time, Epi proColon® 2.0 is in advanced stages of the “Premarket Approval” (PMA) process in the US. The Epi proColon® 2.0 CE test features improved clinical performance, easier handling and automation, and a shorter time to results. It is manufactured under ISO 13485 and cGMP by our contract manufacturer Bioserv in their San Diego facility. We intend to complete the FDA submission in 2012 and to reach our ultimate goal of introducing Epi proColon® as the first FDA-approved blood-based test for the early detection of colorectal cancer into the U.S. market.

Furthermore, we aim to leverage the value of our methylated Septin9 biomarker for colorectal cancer, potentially in combination with other proprietary biomarkers, in patient management (e.g. monitoring disease recurrence and potentially, prognosis assessment).

Lung Cancer

Epi proLungEpi proLung is used to test bronchial lavage samples marketed in Europe as a CE-marked IVD test. Our additional R&D in lung cancer focuses on developing assays that detect the methylated SHOX2 biomarker at the core of Epi proLung in further sample types, such as blood plasma. This potentially broadens the applicability of this biomarker as an aid in the diagnosis of lung cancer.

Prostate Cancer

mPITX2Our lead program in prostate cancer focuses on the methylated PITX2 biomarker, which provides independent prognostic information in breast and prostate cancer. After consolidating our assay technologies used in IVD products, we are now in the process of developing a convenient real-time PCR assay for methylated PITX2 for use on surgical samples for patients undergoing prostatectomy as well as prostate biopsies. This will allow us to assess the prognosis of an individual cancer patient as early as possible in the diagnosis work up and potentially allow the urologist to make a more informed treatment decision.

In addition, we have out-licensed methylated GSTP1 biomarker to Quest Diagnostics and Predictive Biosciences for use in laboratory-developed tests that potentially augment the initial diagnosis of prostate cancer on biopsy material (e.g. taken as a follow-up to a positive PSA test).