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ERG Monoclonal Antibody [9FY] Patent issued to the Uniformed Services University of the Health Sciences Center for Prostate Disease Research & Biocare Medical
Concord, CA, August 21, 2014 – The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. has been awarded a patent in the United States (Patent No: US 8,765,916 B2) and Europe for ERG monoclonal antibodies. The patent is pending in Australia, Canada and Japan. ERG mouse antibody 9FY is a rigorously characterized antibody for its specificity of the ERG protein detection among the closely related members of the ETS transcription factor family in biological specimens.
ERG gene fusions are among the most validated cancer genome defects present in half of all prostate cancers in western countries. The 9FY clone provides robust and specific detection of the ERG protein, the product of ERG fusions in prostate cancer specimens. Based on the 99.9% specificity of the 9FY, the utilization of this antibody may aid in diagnosis of prostate biopsies with inconclusive results to ascertain the diagnosis of prostatic carcinoma. Repeat biopsies may only be necessary when ERG positive PIN is identified as there is a 97% chance of finding an ERG positive prostatic carcinoma.
ERG [9FY] may have diagnostic utility for prostate cancer, acute myeloid leukemia and vascular tumors. It is helpful in minute foci of prostatic acinar carcinoma in prostate biopsy specimens. 9FY can accurately discriminate between ERG positive prostate cancer cells and lymphocytes and other cell types, helping to establish prostatic origin in metastatic carcinomas to lymph nodes or other metastatic sites. It may also be used to diagnose tumors of endothelial origin, such as angiosarcoma, variants of hemangioma, Kaposi sarcoma, and staging AML lymphoid tumors. ERG may also detect or confirm vascular invasion and assess microvessel density in tumors other than prostatic carcinomas or cells of endothelial origin, as 9FY stains blood and lymphatic endothelial cells.
Biocare Medical, LLC, is the exclusive distributor of the ERG [9FY] mouse monoclonal antibody for in-vitro diagnostics by immunohistochemistry staining and for research purposes. There are approximately 1 million biopsies per year and about 250,000 new prostate cancers per year in the United States. Approximately 10% are inconclusive biopsies and may require confirmation by ERG staining resulting in 100,000 or more cases per year. The availability of ERG data in biopsies will also be useful in future ERG-targeted treatment of prostate cancer, such as the ongoing clinical trial of PARP inhibitors already in use for triple negative breast cancers.
For more information, go to www.biocare.net
About Center for Prostate Disease Research
The Center for Prostate Disease Research is an internationally recognized inter-disciplinary program of the Department of Surgery of the Uniformed Services University of the Health Sciences, the Department of Defense’s federal health sciences university, in affiliation with the Walter Reed National Military Medical Center, Joint Pathology Center, and many tri-service military medical centers. The center is a collaboration with The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., a private, not-for-profit organization established in 1983 and authorized by Congress to support medical research and education at the Uniformed Services University of the Health Sciences and throughout the broader military medical community.
About Biocare Medical
Biocare Medical, LLC is an innovator in developing and supplying world class automated immunohistochemistry (IHC) instrumentation and the full range of reagents for IHC and ISH lab testing. Biocare Medical is the market leader in simultaneous Multiplex IHC and antibody development, which aids in the assessment of clinical cases and accelerates turnaround time. The company’s customers include clinical histology laboratories, pharmaceutical companies, CROs, and biotechnology companies as well as academic, government, military, and other non-profit laboratories. Biocare Medical offers an expanding portfolio of integrated products to address the rapidly growing cancer and infectious disease diagnostic and research markets using tissue immunostaining and in situ hybridization methods. Biocare Medical is headquartered and has manufacturing facilities in Concord, California, and has a global distribution network. For more information, please visit www.biocare.net.