Prostate cancer stained with ERG antibody.

Photo: Biocare Medical

Concord, Calif — Biocare Medical has entered into a licensing agreement with The Henry M Jackson Foundation for the Advancement of Military Medicine (HJF) for the exclusive world wide sales and distribution rights of the anti-ERG monoclonal antibody (clone 9FY – the CPDR ERG- MAb) for in-vitro diagnostics, prognostics, patient monitoring, and screening by immunohistochemistry. In addition, Biocare Medical under a Cooperative Research and Development Agreement will join in collaboration with researchers at the Uniformed Services University of the Health Sciences’ (USU) Center for Prostate Disease Research (CPDR) and investigators at the Armed Forces Institute of Pathology (AFIP) and Walter Reed Army Medical Center to further study the anti-ERG antibody and its clinical diagnostic potential.

The mouse monoclonal anti-ERG antibody, which specifically recognizes the ERG oncoprotein, was developed at CPDR, a multi-disciplinary prostate cancer translational research program that is part of USU’s Department of Surgery in collaboration with HJF [Furusato, et. al. Prostate Cancer Prostatic Dis. 13, 2010, 228]. Androgen dependent oncogenic activation of the ERG gene as a result of gene fusions has been identified as a potentially causal alteration in 50-70% of prostate cancer patients. The CPDR ERG-MAb provided the first insights into the ERG oncoprotein expression features in the prostate gland and showed an unprecedented specificity (99.9%) for detecting prostate tumor cells. Importantly, there was a strong correlation (97%) between the presence of ERG-positive prostatic intraepithelial neoplasia (PIN) and ERG-positive carcinoma.

ERG oncoprotein is a promising diagnostic marker for identifying prostatic adenocarcinoma and distinguishing it from non-neoplastic prostate and other adenocarcinomas. ERG MAb may also be utilized for detecting ERG protein alterations in Acute Myelogenous Leukemia, Ewing Sarcoma, Kaposi Sarcoma, angiosarcoma, epithelioid hemangioendothelioma, and endothelial components of hemangiomas.

"We are excited about the potential for aiding in the diagnosis of prostate cancer through streamlining the detection of the ERG oncoprotein in clinical specimens using the ERG MAb” said Dr. Shiv Srivastava, USU professor and co-director of the CPDR.

“I am highly impressed with the remarkable specificity and robustness of the ERG MAb in indentifying tumors cells in the prostate” says Dr. Sesterhenn, chair of the Genitourinary Pathology at the AFIP.

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