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.

 

Biocare Medical Awarded Patent for PIN-4™ (CK5/14 + P63 + P504S)

Concord, CA, July 17, 2014 – Biocare Medical is proud to announce that the United States Patent and Trademark Office has issued US Patent 8,603,765 to Biocare Medical for its PIN-4™ (CK5/14 + P63 + P504S) Multiplex immunohistochemistry (IHC) technology. The PIN-4 antibody cocktail of P504S + p63 + High Molecular Weight Cytokeratin permits the simultaneous evaluation of prostate glands and the identification of cancerous foci on a single tissue section, using a two-color staining protocol. The PIN-4 cocktail has become the standard of care for the evaluation of prostate biopsies.

pin-4-web

US Patent 8,603,735.

According to Dr. David Tacha, Chief Scientific Officer at Biocare Medical and inventor of PIN-4, “When the PIN-4 double stain was developed at Biocare Medical, double stain technology using immunohistochemistry methods was virtually nonexistent in most hospitals and universities. PIN-4 became such a valuable tool for interpretation of prostate needle biopsies; it single-handedly cracked the code in the United States. In other words, PIN-4 was the catalyst for the double stain revolution in America.”
For more information, go to http://biocare.net/product/ck514-p63-p504s/

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.

Biocare Medical Launches Research Software for the intelliPATH™ Automated Staining System

Concord, CA, July 7th, 2014 – Biocare Medical is proud to announce the release of a Research Software for use on the intelliPATH Automated Staining System. The intelliPATH Research Software provides an enhanced design tailored to address the specific needs of users within translation research, drug discovery, veterinary pathology, and other tissue-based research areas. This proprietary software offers greater flexibility for the intelliPATH user interface to maximize efficiency and improve workflow while continuing to deliver exceptional results.  We firmly believe that the intelliPATH is the superior semi-automated instrument available on the market and the addition of this new software will provide the utmost in flexibility and productivity within the research laboratory setting.

“We are very excited to expand the capabilities of the intelliPATH with the release of our new intelliPATH Research Software Suite. Not only does this new software provide improved flexibility and efficiency for our current and prospective intelliPATH users in the research setting; it clearly demonstrates our attention to the voice of our customers.” said Rhonda Henshall-Powell, Ph.D., Director of Marketing & Education for Biocare Medical. “We have always listened to our client’s feedback and used this to evolve our product offering; however the intelliPATH Research Software Suite is a direct result of collaborating and working directly with Key Opinion Leaders and listening to their specific needs”

For more information, go to www.biocare.net

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.

Biocare Medical Launches ONCORE™ Automated Slide Staining System

Biocare Medical Launches ONCORE™ Automated Slide Staining System

Concord, CA, April 14, 2014 – Biocare Medical is proud to announce the expansion of their automated instrumentation offering with the release of the ONCORE™ Automated Slide Staining System. The ONCORE is a compact and convenient bench-top instrument that is capable of performing both immunohistochemistry (IHC) and in situ hybridization (ISH) testing procedures on formalin-fixed paraffin-embedded (FFPE) tissues. The on-board capabilities of the ONCORE include: baking, deparaffinization, antigen retrieval, and antibody or probe detection for IHC, ISH, and Multiplex IHC applications. The ONCORE will be accompanied by a suite of proprietary primary antibodies, IHC, and ISH reagents specifically designed to produce exceptional staining quality.

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Biocare Medical Offers a New Mouse Monoclonal SOX10 Antibody

Biocare Medical Offers a New Mouse Monoclonal SOX10 Antibody – a Highly Sensitive and Specific Marker for Malignant Melanoma (Patent Pending).

Concord, CA, February 28, 2014 – Biocare Medical is proud to announce the release of a new mouse monoclonal SOX10 Antibody. The SOX10 protein is widely expressed in normal human tissues including melanocytes and breast tissue. SOX10 has been shown to be expressed 97-100% of desmoplastic and spindle cell melanomas and was also shown to be expressed in 100% of nevi. The majority of oligodendrogliomas, but also a large percentage of astrocytomas and poorly differentiated glioblastomas have also been shown to express SOX10.

(Left) Spindle cell melanoma (DAB); (Right) Pigmented melanoma (Fast red)
(Left) Spindle cell melanoma (DAB); (Right) Pigmented melanoma (Fast red)

“We had a lot of requests for SOX10, as the existing SOX10 antibodies were either RUO or were of poor quality. We carefully designed a sequence that was specific for only SOX10. We also worked closely together with several outside pathologists to ensure the quality and accuracy that is needed for the diagnosis of melanoma and its subtypes,” states Dr. David Tacha, Chief Scientific Officer at Biocare Medical.

For more information, go to http://biocare.net

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.

Applied Spectral Imaging & Biocare Medical Partner to Deliver Comprehensive Solutions for IHC

A partnership making R2R workflow (“Reagent to Report”) a reality by combining Biocare’s automated IHC instrumentation and reagents with ASI’s computer-aided imaging and analysis

Carlsbad, California and Concord, California, December 4, 2013 – Applied Spectral Imaging Inc. (ASI) and Biocare Medical, LLC (Biocare) announced today the signing of a strategic partnership agreement in which Biocare will distribute ASI’s IHC and CISH imaging and analysis solution, GenASIs Pathology, in the United States. The agreement brings to cytopathology and anatomic pathology laboratories a fully integrated solution that improves quality while providing compelling work-flow efficiencies.

Biocare Medical is an innovator in the growing field of automated instrumentation for IHC and ISH. ASI is a leader in multi-modality, microscopy imaging and analysis, offering a suite of automated and semi-automated computer-aided analysis and scoring aids for IHC, CISH, FISH and karyotyping. A combined, end-to-end, automated solution for IHC brings exceptional value, enhanced efficiency and superior clinical results to laboratories which are experiencing a surge in the number of IHC tests performed.

From slide preparation through analysis, all the way to result reporting, the combined solution enables faster turn-around time while providing accurate, reproducible and standardized results. Laboratories benefit from computer aided scoring, counting and ratio analysis, providing Allred, H-score and M-score analysis automation. The system provides standardized results for stains such as ER, PR and HER-2 (cErbB2). Analysis results and automatically generated reports are managed in the solution’s built-in information management system, which may be linked to a Laboratory Information System (LIS).

“Our team is very excited to partner with Biocare. Both companies have worked hard to ensure our customers benefit from unparalleled value in IHC automation, imaging and analysis. The unique value we offer together extends from sample preparation all the way to case sign-out.” said Limor Shiposh, CEO of Applied Spectral Imaging Inc. “Our offering enables pathologists to focus on clinical analysis and investigation, offering accurate, documented and relevant results. The agreement between our two companies provides pathology labs with a complete end-to-end automated and documentation solution.” added Ms. Shiposh.

“I’ve tested quite a few imaging systems for scoring slides and the GenASIs Pathology outperformed all the rest. The biggest benefit of the system is how user-friendly and intuitive the software is, with no extensive training needed. You can sit down and get right to work in minutes,” said Joe Vargas, Director of Research and Development at Biocare Medical.

ASI and Biocare have tested and confirmed the combined solution’s effectiveness in performing end-to-end IHC and CISH, imaging, analysis and reporting.

<strong>About Applied Spectral Imaging</strong>
Applied Spectral Imaging (ASI) makes patient care better through advanced biomedical imaging.

ASI has been one of the industry’s leading microscopy imaging solution providers since 1993, with over 30 registered patents in the US, Europe and Japan and over 2,500 systems deployed worldwide. With worldwide offices in the US, Europe and Asia, ASI has built a global network of over 50 distributors.

GenASIs Pathology (IHC and CISH imaging and analysis solution) is not intended for diagnostic or therapeutic use, for research use only.
For more information, please visit www.spectral-imaging.com

<strong>About Biocare Medical</strong>
Biocare Medical LLC is an innovator in developing and supplying world class automated immunohistochemistry (IHC) instrumentation, and the full range of reagents for IHC lab testing. Biocare is the market leader in simultaneous Multiplex IHC and antibody development, which solves difficult clinical problems 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 http://biocare.net.

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Supernova Antibodies Now Available from Biocare Medical

Concord, CA, June 10, 2013 – Biocare Medical is proud to announce the availability of a new line of Supernova antibodies. Supernovas contain a higher antibody concentration than standard predilutes, providing versatility to a client’s current test menu. At Biocare, we aim to enable the client to consider all options and determine the most optimal product and protocol that best fits their IHC needs.

Clients now have the option of preserving limited tissue specimens while still providing multi-antigen identification in approximately the same time as an antibody cocktail. This is achieved by using Supernova antibodies in sequential incubations combined with Biocare’s double stain detection. Unique cocktails can also be created with ease as Supernova antibodies have been prepared in optimal diluents for specific tissue types. Additionally, Supernova antibodies only require between 10-20 minute incubations, which can shorten protocol time.

Biocare is introducing popular IHC antibodies in prostate, breast, and lung cancers as well as for infectious disease in Supernova format. Widely used prostate cancer IHC markers now available in 2X and 3X Supernova formats include AMACR, CK HMW [34BE12], Cytokeratin 5/14, ERG, P504S, and p63. Breast markers p120 Catenin and E-cadherin and Herpes Simplex Virus 1 and 2 are now available separately as 2X Supernovas. Look for more antibodies coming soon, new releases can be found online at www.biocare.net/supernova.

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.

New Uroplakin II Antibody Available from Biocare Medical

Concord, CA, May 14, 2013 – Biocare Medical is proud to announce the availability of a new Uroplakin II mouse monoclonal antibody (IVD). Studies have shown UP II mRNA to be expressed in both bladder cancer tissues and peripheral blood of patients with primary and metastatic urothelial carcinoma.

Urothelial carcinoma (UC) of the bladder typically originates in the urothelium and accounts for more than 90% of all bladder tumors. Biomarkers expressed in the urothelium, such as uroplakins, could be predictive markers of UC of the bladder. Pathologists have used Uroplakin III [AU1] to establish urothelial origin of the bladder; however use of UP III is limited due to its poor sensitivity. UP II was found to have 79% (44/56) sensitivity for bladder UC compared to 34% (19/56) for UP III [AU1] in a joint study conducted by Biocare Medical, Mercy Health System and Indiana University School of Medicine.

“With the introduction of Uroplakin II as a highly specific and sensitive potential marker of urothelial cancer of the bladder, Biocare Medical continues to improve the IHC resources available for pathologists to establish urothelial origin of the bladder. With bladder cancer being the sixth most common occurring cancer in the United States and given its high recurrence rate, a specific and sensitive tissue-based biomarker for early diagnosis and monitoring is a major clinical need,” says Dr. David Tacha, Chief Scientific Officer of Biocare Medical.

About Uroplakin II
A new mouse monoclonal Uroplakin II antibody [BC21] exhibits an increased staining sensitivity (79%, 44/59) when compared to Uroplakin III [AU1] (34%, 19/56) in cases of urothelial carcinoma of the bladder. With the exception of bladder and ureter, Uroplakin II [BC21] was found to be 100% specific when evaluated in various normal and neoplastic tissues. Uroplakin II [BC21] is a highly specific antibody that may be useful in identifying tumors of urothelial origin. Patent Pending.


UPII (Left) and UPIII (Right) staining on Urothelial carcinoma of the bladder.

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.

Biocare Expands Antibody Choices for Ventana Instruments

Enhancing the VP Echelon product line, Biocare is pleased to announce the addition of p40 mouse monoclonal, Arginase-1, and Uroplakin II to our menu of prediluted antibodies optimized for the Ventana® BenchMark® XT Immunohistochemistry Staining Systems.

The mouse monoclonal antibody p40 [BC28] may have applications in cases where p63 is used. While p63 has proven to be a sensitive marker for lung SqCC, it suffers from specificity limitations due to reactivity in a subset of lung adenocarcinomas. In contrast, p40 is selectively expressed in lung SqCC. p40 (M) [BC28] was found to be a sensitive marker in other neoplastic tissues, including bladder, prostate, breast, and head and neck cancers.

The Arginase-1 (ARG-1) rabbit monoclonal antibody is a highly specific and sensitive marker of hepatocellular carcinoma (HCC). In an in-house study, ARG-1 rabbit monoclonal demonstrated higher sensitivity than the polyclonal and HepPar-1 for all grades of HCC. ARG-1 [EPR 6672B] is very specific, as it does not stain pancreatic tumors and shows limited staining in normal tissues except liver, pancreas, and kidney. ARG-1 provides a more sensitive and specific diagnostic marker delineating primary HCC from tumors metastatic to the liver.

Uroplakin II [BC21] mouse monoclonal is a highly specific antibody that may be useful in identifying tumors of urothelial origin. In cases of urothelial carcinoma of the bladder, [BC21] exhibits increased sensitivity (78%, 46/59) when compared to Uroplakin III [AU1] (34%, 19/56). With the exception of bladder and ureter, Uroplakin II [BC21] was found to be 100% specific when evaluated in various normal and neoplastic tissues, including prostate cancer and renal cell carcinoma. PATENT PENDING.

The VP Echelon line is a collection of optimized and prediluted antibodies that have been tested on the Ventana® Benchmark® XT Immunohistochemistry Staining System. These conveniently packaged reagents are ready for loading into reagent dispensers supplied by Ventana. These antibodies have been titered and quality controlled to assure consistent performance and high quality staining. Biocare provides ready-to-use antibodies in 6.0 ml (60 tests) and 25 ml (250 tests) formats. The product line also includes V-Blocker (universal protein blocking reagent) and Monet Antibody Diluent (only for use with concentrated primary antibodies).
For more information, please visit: http://biocare.net/products/vp-antibodies/.

About Biocare Medical, LLC
Biocare Medical, LLC is an innovator in developing and supplying world class automated immunohistochemistry (IHC) instrumentation, and the full range of reagents for IHC 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.

Thank You for Visiting Biocare Medical at USCAP 2013!

Biocare Medical would like to thank you for making the 102nd Annual United States and Canadian Academy of Pathology in Baltimore, MD a great success! Many attendees took advantage of a great opportunity to learn more about our IHC products from antibodies to instrumentation.

Biocare was proud to be involved in four poster presentations, highlighting some great new & novel antibodies for the breast, bladder and liver. To learn more about Folate Receptor Alpha expression in triple negative breast cancers, Uroplakin II in urothelial carcinomas, E-cadherin rabbit monoclonal in infiltrating ductal carcinomas, or Arginase-1 rabbit monoclonal in hepatocellular carcinomas please visit biocare.net/education/abstracts to download the posters.

I hope that you had a chance to join us for our exhibitor seminar, where we presented on two exciting topics. In lung cancer, small sample size and the need to conserve tissue necessitates the use of marker panels on a single slide. We saw data on how Desmoglein 3 + Cytokeratin 5 + Napsin A and p40 + TTF-1 antibody cocktails are excellent tools for differentiating primary lung adenocarcinomas from squamous cell carcinomas. In addition, we learned that folate receptor alpha (FRA) is frequently expressed in ER/PR negative and triple negative breast cancers. Determining positive FRA expression in breast cancers may identify patients that would benefit from an anti-folate targeted therapy.

We look forward to seeing everybody next year at USCAP 2014 in San Diego, CA!