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 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 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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