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.

New p40 Mouse Monoclonal Antibody Available from Biocare Medical

Biocare Medical is proud to announce the availability of a new highly specific p40 mouse monoclonal antibody (IVD). Mouse monoclonal anti-p40 [BC28] demonstrated similar sensitivity and specificity as the rabbit polyclonal p40, staining 97% (65/67) of cases of lung squamous cell carcinoma (SqCC) and 0% (0/71) cases of lung adenocarcinoma (ADC), in an in-house study. In addition, the mouse monoclonal antibody has significantly less background and does not stain macrophages. The mouse monoclonal anti-p40 [BC28] was developed wholly by Biocare Medical through an intensive effort to identify an anti-p40 clone with superior staining performance in immunohistochemistry (IHC). p40 (M) [BC28] is available exclusively from Biocare Medical and its worldwide network of distributors (Patent pending).

p40 may have applications in cases where p63 has traditionally been used as an IHC marker. In recent studies, staining with rabbit polyclonal p40 was equivalent to p63 [4A4] in sensitivity for lung squamous cell carcinoma (SqCC), but p40 exhibited markedly superior specificity due to staining in fewer cases of lung adenocarcinoma (ADC) compared to p63 (1-3). p40 has also been reported in combination with TTF 1 in a method to improve specificity for SqCC vs. ADC, while preserving limited tissue specimens (3,4).

“Biocare Medical continually strives to improve the diagnostic tools available to pathologists. With the introduction of the p40 monoclonal antibody, we hope to further enhance confidence in a patient’s diagnosis; especially in cases of discriminating lung SqCC vs. ADC, where a correct diagnosis is critical for therapeutic direction. The p40 monoclonal antibody shows equivalent sensitivity, but superior specificity compared to p63 and should become the standard IHC marker for lung cancer” says Dr. David Tacha, Chief Scientific Officer of Biocare Medical.

About p40 (M)
The mouse monoclonal antibody p40 [BC28] recognizes an epitope unique to the p40 protein and may have applications in cases where p63 has traditionally been used. To date, p63 [4A4] has been a frequently used marker for lung squamous cell carcinoma (SqCC), as well as for bladder, breast, prostate, and head and neck cancers. p63 [4A4] recognizes both the p63 and p40 proteins. As a result, p63 has proven to be a sensitive marker for lung SqCC; however it suffers from specificity limitations due to reactivity in a subset of lung adenocarcinomas (ADC). In contrast, p40 is selectively expressed in lung SqCC, offering an opportunity for improved specificity (1-3). Changes in expression of p40 have been implicated in other neoplastic tissues, including bladder, prostate, breast, and head and neck cancers. p40 (M) [BC28] was found to be a sensitive marker in each of these tissues. Studies have strongly supported the routine use of p40 as an alternative for p63 (1, 2).

References
(1) Bishop JA, et al. Mod Pathol. 2012 Mar;25(3):405-15.
(2) Nonaka D. Am J Surg Pathol. 2012 Jun;36(6):895-9.
(3) Pelosi G, et al. J Thorac Oncol. 2012 Feb;7(2):281-90.
(4) Brown AF, et al. Arch Pathol Lab Med. 2013 Jan 4.

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.

Ventana and Biocare Medical sign p63 license agreement to aid in the differential diagnosis of benign and malignant prostate lesions

Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group and Biocare Medical, LLC (Biocare) today announced that they have entered into a non-exclusive license agreement to allow Biocare access to certain patents and materials related to p63 diagnostics in the research and IVD field. In parallel, Biocare and AsymmetRx Medical, Inc. (AsymmetRx) have settled their dispute as it relates to the p63 technology. As part of the settlement, Biocare has gained a worldwide license through Ventana to distribute p63 (4A4) mouse monoclonal primary antibody in both the research and IVD market and AsymmetRx has agreed to terminate all patent infringement litigation. AsymmetRx holds the exclusive, worldwide license under the Harvard Medical School patent filings for the use of the p63 antibody as an aid in the diagnosis of prostate and other cancers. Financial terms of the license and settlement were not disclosed.

“Our mission is to improve the lives of all patients afflicted with cancer,” says Mara Aspinall , President, Ventana Medical Systems, Inc. “Through our licensing program, we make the most advanced products in the industry available to those in need and help ensure the standardization of diagnostic results to benefit patients.”

The p63 gene was discovered in the Harvard lab of Dr. Frank McKeon and the p63 cancer diagnostic test was invented by a collaboration of labs at Harvard Medical School, Dana Farber Cancer Institute and the Brigham and Women’s Hospital. p63 protein is highly expressed in prostate, breast, bladder, and lung tissue and the p63 (4A4) mouse monoclonal antibody has been extremely useful in the differentiation of benign and malignant lesions in conjunction with morphological findings. Numerous articles in top clinical journals have cited the accuracy and utility of p63 as an aid in prostate cancer diagnosis, and it has become the gold standard used by leading hospitals, laboratories and experts worldwide.

“Including p63 in our lung, prostate and breast panels really empowers our Multiplex IHC platform to aid pathologists in making critical decisions and solidifies our passion for patient care and the ability to fight cancer one slide at a time,” says Roy Paxton Yih , President & CEO, Biocare Medical, LLC.

“Prostate cancer is one of the most difficult cancers to diagnose, and the p63-based test adds a significant advantage to making the correct diagnosis. We are very excited about our agreement with Ventana, and now Biocare, as it will provide a platform to bring the p63 diagnostic tests to patients worldwide,” says Peter F. McKeon , President, AsymmetRx Medical, Inc.


p63 (4A4) mouse monoclonal primary antibody.

About Ventana Medical Systems, Inc.
Ventana Medical Systems, Inc. (“VMSI”) (SIX: RO, ROG; OTCQX: RHHBY), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. VENTANA solutions are used in clinical histology and drug development research laboratories worldwide. The company’s intuitive, integrated staining, workflow management platforms, and digital pathology solutions optimize laboratory efficiencies to reduce errors, support diagnosis and inform treatment decisions for anatomic pathology professionals. Together with Roche, VMSI is driving Personalized Healthcare through accelerated drug discovery and the development of “companion diagnostics” to identify the patients most likely to respond favorably to specific therapies.
VENTANA and the VENTANA logo are trademarks of Roche.
Visit www.ventana.com to learn more.
Ventana Medical Systems, Inc.
Empowering | Innovation
VMSI Media Relations 
Jacqueline Bucher 
Senior Director, Corporate Communications
Phone: 520-877-7288 
e-mail: jacquie.bucher@ventana.roche.com
Request High Resolution Files

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 inConcord, California, and has a global distribution network. For more information, please visit www.biocare.net.

About AsymmetRx Medical

AsymmetRx Medical, Inc. is privately held and was founded in 2001 by scientists from Harvard University and Johns Hopkins University to develop novel diagnostics, imaging agents, and therapies for urologic cancers including those affecting the bladder and prostate. Using strategies based on key advisors from private and academic clinicians and pathologists specializing in urologic cancers, AsymmetRx is committed to developing the most accurate tests for the analysis of prostate and bladder biopsies, as well as early detection tests that in the future will obviate the need for needle biopsies. AsymmetRx is committed to developing systems of imaging urologic cancers that will aid in the early treatment of such diseases, as well as therapies based on specific targeting of malignant cells in urologic cancers. The Wall Street Journal recognized AsymmetRx for one of the “Best Technologies” in the Biotech medical field in 2005. AsymmetRx succeeded in developing the first FDA cleared test for prostate cancer in needle biopsies based on the p63 antibody. It is anticipated that the p63-based test will assist in the accurate diagnosis and treatment of hundreds of thousands of men in the United States alone. More detailed information on the company and its mission may be found at www.asymmetrxmedical.com.

© 2013 Ventana Medical Systems, Inc.
VENTANA and the VENTANA Logo are trademarks of Roche.
All other trademarks are the property of their respective owners.

Biocare Medical Launches Key Diagnostic Kit to Identify Folate Receptor Alpha Expression

-New Assay, Developed in Collaboration with Morphotek, Uses Proprietary Technology-

Concord, CA and Exton, PA, March 20, 2012 – In partnership with Morphotek® Inc., a subsidiary of Eisai Inc., Biocare Medical announced the release of its in vitro diagnostic immunohistochemical (IHC) kit to detect folate receptor alpha (FRalpha) expression in formalin fixed paraffin embedded (FFPE) tissues at the U.S. College of Anatomical Pathology Conference in Vancouver, British Columbia earlier this week. The kit will be available in the U.S. as a Class I IHC IVD assay and is CE marked for use in Europe.

The introduction of this new assay, the result of a collaboration between Morphotek and Biocare, is intended to determine which patient tumors express FRalpha, which may support the development of new cancer treatments.

“The development of a highly characterized and high affinity folate receptor alpha antibody IHC kit is extremely important; not only for its potential use in the development of targeted therapeutics, and hopefully it could be developed into an independent prognostic marker for various cancers,” said Dr David Tacha, Chief Scientific Officer and VP of R&D, Biocare Medical.

“Having an IHC kit to detect folate receptor alpha will support our efforts to identify new treatments for a variety of cancers,” said Elizabeth Somers, Associate Director Diagnostic Development of Morphotek. “We are pleased to be part of the development of such an assay because having the ability to identify patient tumors that are positive for a target will enable us to learn more about the disease and the behavior of cancers that are expressing a given target.”

Morphotek, which has expertise in monoclonal antibody development, licensed its proprietary monoclonal antibody 26B3, which specifically detects human folate receptor alpha, to Biocare in March, 2011 for the development of this kit for use with Biocare’s intelliPATH™ Automated IHC Stainer or in a manual format.

Biocare has worldwide rights to manufacture and distribute the kit, which will detect folate receptor alpha on a variety of tumor tissues.

About Folate Receptor Alpha

Mouse anti-human folate receptor alpha monoclonal antibody 26B3 specifically recognizes the alpha isoform of folate receptor. FRalpha is a cell surface protein that is primarily expressed on the apical surface of some polarized epithelial cells of normal tissues (such as kidney, lung, breast, and salivary glands) and on several cancers of epithelial origin, including ovarian cancer, thyroid cancer, non-small cell lung adenocarcinoma (NSCL) and endometrial cancers.

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 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, Calif., and has a global distribution network. For more information, please visit www.biocare.com.

About Morphotek

Morphotek®, Inc., a subsidiary of Eisai Inc., is a biopharmaceutical company specializing in the development of protein and antibody products through the use of a novel and proprietary gene evolution technology. The technology has been successfully applied to a broad variety of cell lines and organisms to yield genetically diverse offspring that are suitable for pharmaceutical product development in the areas of antibody therapeutics, protein therapeutics, product manufacturing, drug target discovery, and improved output traits for commercial applications. The company is currently focusing its platform on the development and manufacturing of therapeutic antibodies for the treatment of cancer, inflammation and infectious disease. For more information, please visit www.morphotek.com

About Eisai Inc.

Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. Since that time, Eisai Inc. has rapidly grown to become a fully integrated pharmaceutical business. Eisai’s key areas of commercial focus are neurology and oncology. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.

Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as manufacturing facilities in Maryland and North Carolina. The company’s areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com/US.

Media Contacts:
Rhonda Henshall-Powell
Biocare Medical
925-603-8041
rhenshallpowell@biocare.net

Terry Cushmore
Morphotek, Inc.
610-423-6197
tcushmore@morphotek.com

Lynn Kenney
Eisai Inc.
201-746-2294
lynn_kenney@eisai.com

Investor Contacts:

Rod Dausch
Morphotek, Inc.
610-423-6111
Dausch@morphotek.com

Alex Scott
Eisai Inc.
201-746-2177
alex_scott@eisai.com

Biocare Medical expands its PromARK™ detection product line to horse, cow, pig & sheep tissues

Biocare Medical proudly introduces four newly developed horseradish peroxidase (HRP) and alkaline phosphatase (AP) polymer detection systems for horse, cow, pig and sheep tissues. These Mouse-on-Farma and Rabbit-on-Farma HRP and AP polymers are specifically designed to achieve excellent staining quality when using mouse or rabbit primary antibodies. The advanced polymer technology virtually eliminates cross-reactivity to endogenous equine, bovine, porcine and ovine IgGs, increases sensitivity and reduces IHC steps (no Avidin/Biotin block or Link/Probe). The polymers are intended for use on formalin-fixed, paraffin-embedded (FFPE) tissues and are suitable for both manual and automated protocols. These additions to Biocare’s PromARK series expand IHC detection applications to a broader range of animal tissues, resulting in increased research capability.

To learn more visit: http://biocare.net/products/detection/promark/

About Biocare Medical
Biocare Medical LLC is an innovator in developing and supplying world class automated immunohistochemistry 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, Calif., and has a global distribution network.

Biocare Medical Launches a Multiplex IHC test for bladder carcinoma differentiation: Uro-2™ (CK20 + p53)

Enhancing the Multiplex IHC product line, Biocare is pleased to announce the addition of Uro-2™ to our bladder cancer diagnosis and differentiation line. Having a more accessible clinical utility, the Uro-2™ (CK20 + p53) can be used to differentiate urothelial reactive atypia from CIS (carcinoma in situ) in the bladder. For urothelium with cases of marked reactive atypia, CK20 and p53 staining remain identical to those seen in normal urothelium. In cases of CIS, diffuse, strong cytoplasmic reactivity for CK20 and diffuse nuclear reactivity for p53 is observed throughout the urothelium. This practical Multiplex IHC test aids the pathologist in differentiating between high and low grade dysplasia in bladder urothelium.

To learn more about Uro-2™ visit http://biocare.net/products/antibodies/u/3001ds/

About Biocare Medical
Biocare Medical LLC is an innovator in developing and supplying world class automated immunohistochemistry 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, Calif., and has a global distribution network.

Biocare Medical Is Once Again Named One of America’s Fastest-Growing Private Companies on Inc. Magazine’s Exclusive List, Inc. 500|5000

Biocare Medical Ranks No. 2781 on the 2011 Inc. 500 | 5000 with Three-Year Sales Growth of 79%

Concord, CA, October 10, 2011 – Biocare Medical ranked No. 2781 in Inc. Magazine’s fifth annual Inc. 500|5000, an exclusive ranking of the nation’s fastest-growing private companies. This represents the third consecutive year that Biocare Medical has placed the list.


“To be recognized as one of the nation’s fastest-growing private companies is a huge honor, and we are more than pleased to be given such notice once again,” said Roy Paxton Yih, co-founder and CEO of Biocare Medical. “Our company’s achievements and rapid growth is due to our unique mission to advance patient care with award-winning customer service and technical support.”

In a stagnant economic environment, median growth rate of 2011 Inc. 500|5000 companies remains an impressive 94 percent. The companies on this year’s list created 350,000 jobs in the past three years, and combined revenue of $366 billion, up 14 percent from last year. “Now, more than ever, we depend on Inc. 500/5000 companies to spur innovation, provide jobs, and drive the economy forward. Growth companies, not large corporations, are where the action is,” says Inc. magazine Editor Jane Berentson.

The 2011 Inc. 5000 is ranked according to percentage revenue growth when comparing 2007 to 2010. To qualify, companies must have been founded and generating revenue by March 31, 2007. Additionally, they had to be U.S.-based, privately held, for profit, and independent as of December 31, 2010. Complete results of the Inc. 5000, including company profiles and an interactive database that can be sorted by industry, region, and other criteria, can be found at www.inc.com/5000.

About Biocare Medical
Biocare Medical LLC is an innovator in developing and supplying world class automated immunohistochemistry 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, Calif., and has a global distribution network.

Biocare Medical
4040 Pike Lane
Concord, CA 94520
1-800-799-9499
customerservice@biocare.net

About Inc. Magazine
Founded in 1979 and acquired in 2005 by Mansueto Ventures LLC, Inc. (www.inc.com) is the only major business magazine dedicated exclusively to owners and managers of growing private companies that delivers real solutions for today’s innovative company builders. With a total paid circulation of 710,106, Inc. provides hands-on tools and market-tested strategies for managing people, finances, sales, marketing, and technology. Visit us online at www.inc.com.