HPV Probes Now Available from Biocare Medical

Biocare Medical, LLC is pleased to announce the availability of a comprehensive line of HPV probes for in situ hybridization. Each digoxigenin-labeled individual probe is designed to detect HPV DNA viral subtypes 6, 11, 16, 18, 31 or 51.

Almost 80 million Americans are infected with Human Papilloma Virus (HPV), with about 14 million becoming newly infected each year. HPV is considered to be the most common sexually transmitted infection. Although relatively rare, cervical cancer resulting from HPV infection with so-called “high risk” viral subtypes afflicts over 11,000 women every year in the United States. Low risk HPV subtypes are responsible for 360,000 annual cases of genital warts and a smaller number of recurrent respiratory papillomatosis cases.

“With the introduction of our line of HPV probes, Biocare Medical strives to improve the molecular diagnostic tools available to pathologists, as well as advance diagnostic confidence. This is especially critical in cases of discriminating HPV-positive vs. HPV-negative oropharyngeal squamous cell carcinoma, where a correct diagnosis reduces therapy-related morbidity,” says Dr. David Tacha, Chief Scientific Officer of Biocare Medical.

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 Finalizes Acquisition of CymoGen Dx

Biocare Medical, LLC is pleased to announce that the acquisition of New Windsor, NY based CymoGen Dx, LLC has been finalized. “We are very excited to be adding the portfolio of FISH [Fluorescent in situ Hybridization] probes from CymoGen Dx to our ever-expanding offerings in the Molecular Diagnostic arena,” said Roy Paxton Yih, President & CEO of Biocare. “The advanced Del-TECT™ PTEN and TMP/ERG probe technologies solidify Biocare’s position as the innovation leader in solid tissue prostate markers that began with the release of our groundbreaking PIN-4™ [CK5/14 + P63 + P504S] Multiplex immunohistochemistry [IHC] technology.” The high caliber CymoGen Dx team are “…very excited to now be a part of this innovative company and believe the efforts of our combined teams will bring added value for our customers”.

About CymoGen Dx
CymoGen Dx, named for its mission to provide state-of-the-art cytomolecular genetics diagnostic research products, is a national provider of advanced tools for identifying genomic aberrations in cancer cells found in tissue and bone marrow specimens. The products include unique 4 color FISH probes utilizing “Deletion Detection Probe” technology (Del-TECT™) that allow for greater accuracy in detecting genomic changes than ever before with enhanced accuracy in paraffin-embedded tissues common to pathology and pharmaceutical research.

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.

PAX8 Monoclonal Antibody [BC12] Patent issued Biocare Medical

Biocare Medical, LLC has been awarded United States Patent No. US 8,852,592 for the anti-PAX8 mouse monoclonal antibody, clone [BC12]. This mouse monoclonal PAX8 antibody [BC12] has been designed to target a restricted epitope and exhibits higher specificity and provides sharper staining than the PAX8 rabbit polyclonal antibody. This clone was developed in-house and is exclusive to Biocare Medical.

PAX8 is expressed in a high percentage of renal cell carcinomas and ovarian cancers. Unlike the polyclonal PAX8, this mouse monoclonal antibody does not stain B-cells, and does not recognize epitopes of pancreatic origin and neuroendocrine cells in stomach and colon; thus providing superior specificity. The expression of the mouse monoclonal PAX8 target antigens was found in normal kidney, thyroid and cervix, but was not identified in normal ovary. By Western blot, [BC12] has been shown to recognize PAX8 and not PAX2, PAX5 or PAX6 proteins. PAX8 stains nuclei exclusively and performs well in formalin-fixed paraffin-embedded tissues. Further details are described in the following paper: Tacha D, et al. Appl Immunohistochem Mol Morphol 2013 Jan; 21(1):59-63.

To learn more visit:
http://biocare.net/product/pax8-antibody/

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 announces agreement to acquire Cymogen DX

Concord, California, October 3, 2014 – Biocare Medical, LLC is proud to announce that they have entered into an agreement to acquire New Windsor, NY based CymoGen Dx, LLC. “CymoGen’s broad product line of Next-Gen™ FISH [Fluorescent in situ Hybridization] probes for detection of genetic anomalies in tissue samples adds to Biocare’s growing presence in the Molecular Diagnostics Market,” said Roy Yih, CEO of Biocare. “Of particular importance are probes PTEN, TMPRSS-ERG, and AR which will complement Biocare’s leading position in solid tissue IHC prostate markers.” Biocare’s recently released ONCORE™ Automated Staining platform has the capability to process slide-mounted FFPE (formalin-fixed, paraffin-embedded) tissue samples through the entire in situ hybridization process. Optimization of the CymoGen Dx FISH product line for use on the ONCORE will be a key goal of Biocare’s immediate product development activities.  Terms of the transaction were not disclosed.

About CymoGen Dx
CymoGen Dx, named for its mission to provide state-of-the-art cytomolecular genetics diagnostic research products, is a national provider of advanced tools for identifying genomic aberrations in cancer cells found in tissue and bone marrow specimens.  The products include unique 4 color FISH probes utilizing “Deletion Detection Probe” technology (Del-TECT™) that allow for greater accuracy in detecting genomic changes than ever before  with enhanced accuracy in paraffin-embedded tissues common to pathology and pharmaceutical research.

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.

ERG Monoclonal Antibody [9FY] Patent issued…

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 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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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.