WILEX produces and markets diagnostic tests under the Oncogene Science brand through its US subsidiary WILEX Inc. These tests serve to identify and classify tumour cells that express certain receptors/antigens. This enables the classification of tumours that share morphological aspects, but behave differently as regards growth or dissemination (tumour aggression, metastasis), or differ in terms of therapeutic response. Diagnostic tests are thus the basis for the future of personalised medicine – i.e. the provision of targeted and specific patient diagnostic options and therapies. Patient selection that combines protein measurement with the corresponding bioanalytical methods may make it possible to predict whether and how patients will respond to a therapy or to monitor the progression of their disease. A prominent example for targeted therapy is the use of Herceptin for certain types of breast cancer (HER-2/neu-positive) following patient stratification with the help of a biomarker test. WILEX Inc. currently offers seven biomarker assays for a variety of oncological targets or genes.

In the field of in vitro tests, a distinction is made between ELISA tests and immunohistochemical (IHC) tests. The ELISA acronym stands for “enzyme-linked immunosorbent assay”. Such tests utilise an enzyme-linked response to show the presence of interactions between antigens (e.g. pathogens) and antibodies (immunoglobulins). In this way, one can determine the presence and quantity of antibodies for a certain infection in a person. Immunohistochemical tests are assays using biological tissue. These tests are used to mark proteins on tissue sections and make these visible under the microscope.

WILEX’s HER-2/neu ELISA assay is the FDA-cleared in vitro diagnostic blood test for quantifying the serum HER-2/neu level in women with metastatic breast cancer as a criterion for a suitable therapy. HER-2/neu identification may be utilised during and following therapy in connection with follow-up examinations in patients with metastatic breast cancer.

For research only use (RUO), WILEX Inc. offers ELISA tests to determine the level of CAIX, uPA, PAI-1, EGFR and TIMP proteins/antigens in blood or plasma. An IHC test is also offered for the CAIX antigen.

In clinical trials, it would be possible to deploy CAIX ELISA and IHC tests with the diagnostic and therapeutic product candidates REDECTANE® and RENCAREX®; uPA and PAI-1 ELISA tests could be deployed with the uPA inhibitor MESUPRON®.

Companion diagnostics is still considered a fairly young discipline. However, the regulatory authorities in both the United States and Europe are already developing guidelines specifying requirements for such products. Two of the largest consultancy firms in the US health care sector – Medco Health Solutions Inc. and CVS Caremark Corp. – both recommend this new approach in order to cut costs and improve treatment outcomes.

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