NUCLEA BIOTECHNOLOGIES, INC. AND WILEX INC. ANNOUNCE PARTNERSHIP

March 20, 2013

Nuclea will offer the WILEX Inc. IVD serum HER-2/neu ELISA test starting in April

 Pittsfield, MA / Munich, Germany – Biomarker pioneer Nuclea Biotechnologies, Inc. today announced a new long-term partnership with WILEX Inc. (ISIN DE0006614720/ WL6 / FSE) which could lead to more effective treatment management for women with metastatic breast cancer. The pairing of the Pittsfield and Worcester-based biotech firm with one of Cambridge’s leading oncological biotech firms will greatly advance research and development of biomarkers, a vital component in the growing field of personalized medicine. 

 Nuclea discovers and develops biomarkers (genes and proteins) and diagnostic assays that can help predict which courses of treatments will be effective for certain patients, depending on their genetic makeup.  Nuclea has the capability and expertise to perform in vitro diagnostic (IVD) assays in the area of oncology in a certified laboratory (CLIA) and also has access through its business relationships with hospitals and research institutions to patients in need of such tests.

 In April, the clinical testing will begin in Nuclea’s newly designed, state of the art laboratory in Pittsfield, and will result in the addition of three new employees. The partnership between Nuclea and WILEX will allow oncologists greater access, through Nuclea’s laboratory, to the ELISA test to measure the HER-2/neu level in the serum portion of blood. HER-2, Human Epidermal Growth Factor Receptor 2, is a gene in the body that produces proteins which assist in the growth of cells.   The serum HER-2/neu level is valuable to doctors for monitoring response to therapy and progression of disease. 

"Nuclea is excited about the new partnership," said Patrick J. Muraca, President & CEO of Nuclea. "Both companies seek to develop new biomarkers with the goal of making 21st century cancer treatments more personal and effective. With our combined experience in the production and commercialization of biomarkers, it seemed very natural for us to work together as pioneers in the field of breast cancer."

Professor Olaf G. Wilhelm, CEO of WILEX Inc. and WILEX AG, commented: "Since Nuclea understands and focuses on gene and protein expression profiles in tumors, the serum HER-2 test is an important addition to their profiling efforts. Besides using our HER-2 ELISA in its CLIA lab Nuclea will also start R&D and validation of this test in early breast cancer and possibly other indications."


About Nuclea Biotechnologies, Inc.

Nuclea Biotechnologies, Inc. is headquartered in Pittsfield, Massachusetts with additional operations in Worcester, Massachusetts. Nuclea has developed and is commercializing eleven unique diagnostic tests for colon, breast, leukemia, lung and prostate cancer.  Nuclea also performs research leading to novel molecular oncology therapeutics and diagnostics for the pharmaceutical and biotechnology industries. 

About WILEX Inc.

WILEX Inc. is a wholly owned US subsidiary of WILEX AG, Munich, Germany (ISIN DE0006614720; WL6, FSE). The team has many years’ experience in developing and manufacturing biomarker tests for oncology, which are marketed under the brand name Oncogene Science. The product portfolio includes enzyme-linked immunosorbent assays (ELISA) and immunohistochemical (IHC) assays for in vitro diagnostic (IVD) and research use only (RUO). With the aim of supporting treatment regimens for cancer patients worldwide WILEX Inc. offers biomarker tests for measuring oncogenes, growth factor receptors (HER-2/neu, EGFR), proteases and protease inhibitors (uPA, PAI-1, TIMP-1), as well as markers of hypoxia (CAIX). WILEX Inc. is based in Cambridge, MA, USA and also provides GMP and ISO certified manufacturing services. More information is available at http://www.oncogene.com.

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