PSAT1 – project supported by the German ZIM-BMWi*

(*Zentrales Innovationsprogramm Mittelstand des Bundesministeriums für Wirtschaft und Energie)

The project is carried out by Therawis Diagnostic GmbH (applicant) in collaboration with its partner the Institute of Pathology of the Technische Universität Munich.

PSAT1 test

The goal of the project is 1) to develop a clinically useful immuno-histochemical (IHC) test to detect PSAT1 protein (Figure 1) expression in formalin-fixed paraffin-embedded (FFPE) breast cancer samples and 2) to establish a predictive test for the treatment of breast cancer patients with Tamoxifen (endocrine cancer therapy) to identify those patients who have a high probablilty to benefit of such therapy and who have a low probability to benefit and could avoid unnecessary toxic side effects.

PSAT1 project in a nutshell

  • Approximately 80% of breast cancer patients are estrogen-receptor positive and the majority of those are treated according to guidelines with endocrine therapy. About 40% of patients benefit of this kind of therapy, whereas a significant number of breast cancer patients suffer from side effects due to treatment by endocrine cancer therapy, e.g. by treatment with the estrogen antagonist Tamoxifen. (see figure)

  • The PSAT1 test in development could identify those breast cancer patients who will most likely benefit from this therapy. At the same time, patients who are unlikely to respond to the therapy could be spared the side effects.

  • So far, a clinically useful routine test is not available.

  • The aim of the project is to chemically simulate the denaturation of the molecule by structural modeling of the PSAT1 molecule and subsequently to generate specific, monoclonal antibodies to detect formalin-fixed PSAT1 protein in tumor tissues from breast cancer patients.

  • Our goal is to develop a cost-effective, immuno-histochemical PSAT1 test suitable for routine testing in FFPE tumor tissue.