IVD CK HMW + p63 + AMACR (RM) Available from Biocare Medical

Concord, CA, August 27, 2015 – Biocare Medical is proud to announce the availability of CK HMW + p63 + AMACR (RM) as an IVD double-stain for Multiplex IHC™. This patented antibody cocktail may be useful in the evaluation of normal prostate glands, prostatic intraepithelial neoplasia (PIN) and prostatic adenocarcinoma (1,2).

Previously, this product was available as an RUO with CK 5/14, p63 and P504S. This updated version has replaced the P504S rabbit polyclonal antibody with AMACR, the equivalent rabbit monoclonal antibody, which will reduce lot-to-lot variability and non-specific background. CK 5/14 has been replaced with high molecular weight cytokeratin clone 34βE12, which is directed to CK1, 5, 10, 14, and specifically stains basal cells in prostate specimens. This updated mixture of antibodies was selected to provide specific and sensitive staining of PIN, prostate adenocarcinoma and normal prostate glands.

The introduction of this as an IVD (in vitro diagnostic) product will now allow clinical laboratories to utilize this double stain without the additional validation and disclaimer needed to previously run this double stain as a LDT (lab developed test). An IVD label also provides reasonable assurance of the product’s safety and effectiveness.

Biocare Medical is an innovator in developing world-class IHC antibodies and reagents for clinical cancer diagnostics. With the patented IVD CK HMW + p63 + AMACR (RM) Multiplex IHC™ now available, Biocare has improved upon the original groundbreaking prostate double-stain, also a Biocare exclusive development.

About CK HMW + p63 + AMACR (RM)
Studies have shown that combinations of CK HMW [34βE12], p63, and/or AMACR may be useful in the evaluation of normal prostate glands, prostatic intraepithelial neoplasia (PIN) and prostatic adenocarcinoma (3). In prostate, CK HMW [34βE12] has been shown to be a useful marker of basal cells of normal glands and PIN, a precursor lesion to prostatic adenocarcinoma; whereas invasive prostatic adenocarcinoma typically lacks a basal cell layer (3-5). p63, a homolog of the tumor suppressor p53, has been detected in nuclei of the basal epithelium in normal prostate glands; however, it was not expressed in malignant tumors of the prostate (6). α-Methylacyl coenzyme A racemase (AMACR), also known as P504S, has been shown to be a specific marker of prostatic adenocarcinoma (7-10). Additionally, prostate glands involved in PIN have been found to express AMACR, whereas AMACR was nearly undetectable in benign glands (10-11).
U.S. Patent 8,603,765 and patents pending

Prostate cancer stained with CK HMW + p63 + AMACR (RM)

Prostate cancer stained with CK HMW + p63 + AMACR (RM)

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 detection 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.

References
1. Shah RB, et al. Am J Clin Pathol. 2004 Oct; 122(4):517-23. 2. Sung MT, et al. Hum Pathol. 2007 Feb; 38(2):332-41. 3. Bostwick DG, Qian J. Mod Pathol. 2004 Mar; 17(3):360-79. 4. Humphrey PA. J Clin Pathol. 2007 Jan; 60(1):35-42. 5. Shah RB, et al. Am J Surg Pathol. 2002 Sep; 26(9):1161-8. 6. Signoretti S, et al. 2000 Dec; 157(6):1769-75. 7. Xu J, et al. Cancer Res. 2000 Mar 15; 60(6):1677-82. 8. Rubin MA, et al. JAMA. 2002 Apr 3; 287(13):1662-70. 9. Luo J, et al. Cancer Res. 2002 Apr 15; 62(8):2220-6. 10. Zhou M, et al. Am J Surg Pathol. 2002 Jul; 26(7):926-31. 11. Wu CL, et al. Hum Pathol. 2004 Aug; 35(8):1008-13.

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.

Thank you for Visiting Biocare Medical at NSH 2014!

Biocare Medical would like to thank you for making the 40th Annual National Society of Histotechnology meeting in Austin, TX a great success! Hundreds had a chance to become a HistoRanger on our Rodeo Extravaganza, braving rodeo-themed games and finishing with a Biocare HistoRanger T-shirt.

Thank you for making the show such a great success. In-between tossing horseshoes, passing the pigs and lassoing the bull’s head, attendees had the opportunity to learn about great IHC reagents and instruments, including the debut of Biocare’s line of histology products and a state of the art image analysis system (via our recent collaborations with General Data Healthcare and Applied Spectral Imaging, respectively).

Congratulations to our HistoRanger winners:

  • 1st place: Kyle Cummings won an iPad Mini by claiming the most points & out-competing all other HistoRangers!
  • 2nd place: Matthew Holm won an iPod by being chosen off our Most Wanted board!
  • 3rd place: Donella & Kate who won an iTunes gift cards by following Biocare on Facebook & Twitter!

Also, congratulations to the team from University of Michigan ULAM who was awarded for the Biocare 2014 Excellence in Patient Care Laboratory Award!

We hope to see everybody next year at NSH 2015 in Washington, DC!

Continue Your Education With our live monthly webinars on:

RISH™ – in situ hybridization simplified
intelliPATH™ – automated slide stainer
ONCORE – automated slide stainer
Multiplex IHC™ – simultaneous antibody staining
IHC Detection – explore principles & procedures

Join one of our Webinars!

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 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.