Biocare Medical Excellence in Patient Care Award at NSH 2018

Utah Gastroenterology is the 2018 recipient of the Biocare Medical Excellence in Patient Care Award. The Utah Gastroenterology Histology Lab is a relatively new, small, private practice histology lab in Salt Lake City. The lab was nominated by the group of pathologists that provide diagnosis for the biopsies taken at Utah Gastroenterology. The pathologists were impressed by the extra efforts the lab takes to provide them with information above and beyond what is needed to make an accurate diagnosis. The histology lab manages a complex workflow, accepting specimens from different locations across the state. Despite this, they are meticulous with their processes, and quality control.

Pictured from Left to Right: NSH President – Diane Sterchi, Laurie Peck – Utah Gastroenterology, Jesse Del Campo – Biocare Medical.

Multiplex IHC – Tech Talk

Multiplex IHC

Biocare™ Medical is the proven leader in providing Multiplex antibody cocktails and detection platforms that enable simultaneous IHC staining with multiple antibodies on a single slide. Our Multiplex detection system simplifies procedures by conserving precious tissue, saving valuable technician time, reducing the number of reagents and steps in the protocol, and allowing for simultaneous evaluation of multiple targets on one slide.

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

Antibody Cocktails

Early on, Biocare recognized the market need for evaluating morphologically distinct markers to aid in solving complex clinical problems and simplifying interpretation, all while conserving precious patient tissue.

The most glaring clinical need was determined to be the ability to differentiate between prostatic intraepithelial neoplasia (PIN) and carcinoma of the prostate. There also needed to be a way to clearly identify any microinvasion or micrometastasis into adjacent prostate tissue. Additionally, this would need to be performed in a clinical laboratory, with superior accuracy and specificity. All of this whilst conserving the limited tissue (prostate needle biopsies are thin filaments of tissue) and reducing the time to result.

With these constraints and needs in mind, Biocare developed our flagship Multiplex IHC cocktail: CK HMW + p63 + AMACR (RM) [formerly known as PIN-4]. 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 adenocarcinoma1,2,3. 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 layer3-5. 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 prostate6. α-Methylacyl coenzyme A racemase (AMACR), also known as P504S, has been shown to be a specific marker of prostatic adenocarcinoma7-10. Additionally, prostate glands involved in PIN have been found to express AMACR, whereas AMACR was nearly undetectable in benign glands10-11.

  • Conserve tissues, time and money = Cost-effective
    • A single Multiplex IHC can replace up to 5 single Ab stains; reducing labor and reagent costs by at least 50%
  • Accurate analysis and easy interpretation of staining results
  • Increase predictive value by combining highly sensitive & highly specific antibodies on one slide
  • More rapidly exclude or diagnose disease states
  • Eliminate multiple slides to evaluate antigen ratios

Multiplex IHC Products

We have also developed Multiplex IHC antibody cocktails for additional tissue applications: Breast, Bladder, Lung, Skin, Colon, Lymphoma, Tumors of Unknown Origin, and Cell Death vs. Proliferation.

Tissue Multiplex Product
Prostate CK HMW + p63 + AMACR (RM)
Breast CK5/14 + p63 + CK7/18
Bladder Uro-2
Lung Desmoglein 3 + p40 (M) + Napsin A (RM)
Skin Pan Melanoma + Ki-67
Colon CDX2 (M) + CDH17 (RM)
Lymphoma Kappa (M) + Lambda (P)
Tumor of Unknown Origin CDX2 + CK7
Death vs. Proliferation Ki-67 + Caspase 3

Clinical 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.

Fixation on Histology Awards Biocare Medical & Jason Ramos Ph.D. Top 5 NSH Presentations!

fixation-on-histology

According to Fixation on Histology, Biocare Medical’s Dr. Jason Ramos, Ph.D. was awarded one of the top 5 best presentations at NSH 2018. For full details read below!

“NSH’s Symposium/Convention is the largest histology conference in the United States with over 100 workshops, an exhibit hall, and plenty of opportunity to network with fellow histologists. If you’re considering attending, especially if it’s your first time, it might seem overwhelming. Fixation on Histology is here to help!

We’ve got the list of top 5 most popular workshops, at this year’s Convention.

5. Molecular Biology Principles and Techniques for the Histotech (WS#56): Molecular pathology is often a less familiar entity for those accustomed to IHC and proteins. This seminar is intended to provide a comprehensive overview of basic molecular biology to offer a better understanding of the applications and diagnostic relevance of molecular pathology. A review of the scientific principles of molecular biology will be conducted. This will include understanding the transcription and translation processes. Different molecular techniques from PCR to ISH will be covered. The pros and cons of these techniques will be discussed, including which molecular techniques and methods are best suited for diagnostic, screening or treatment assessment purposes. The presentation will also look at the future for molecular pathology, and discuss routes for personalized medicine.”

https://www.fixationonhistology.com/home/top-5-workshops-at-the-nsh-symposium-convention
Molecular Biology Principles and Techniques for the Histotech

Biocare Medical PDL1 (CAL10) – Stands Up to the Competition

Biocare-Tech-Talk

Several publications have compared Biocare’s PD-L1 (CAL10) antibody for immunohistochemistry to FDA approved PD-L1 clones SP263 and 28-8 in both rare and prevalent cancer types. Positive and significant correlation of expression, intensity and concordance resulted in both studies. Below is a recent abstract published in the Journal of Clinical Oncology using these different PD-L1 clones in malignant Thymoma and Thymic Carcinoma.  Also included is a link to a study published in Human Pathology using the different PD-L1 clones in Breast Cancer.

journal-of-clinical-oncology

Immunohistochemical staining for programmed cell-death ligand 1 (PD-L1) in malignant thymoma and thymic carcinoma. Alexei Shimanovsky, Richard Cartun, Mary Fiel-Gan, Daniza Mandich, Jonathan Earle, Andrew L. Salner… Abstract e20003

Background: Recent development of anti-PD-1/L1 antibodies has demonstrated activity in various neoplasms. Thymic malignancies (TMS) are rare and treatment in advanced disease is limited. To evaluate the potential impact of anti-PD-1/L1 therapy in TMS, we examined the expression of PD-L1 in previously resected thymoma (TM) and thymic carcinoma (TC). Methods: We examined resected specimens from patients at Hartford Hospital with TM and TC between 2000 and 2014. Expression of PD-L1 was evaluated on formalin-fixed paraffin-embedded tissue. Immunohistochemical testing was done using four different clones of PD-L1 antibodies on the Leica Bond Max automated platform. The four clones include: E1L3N (Cell Signaling Technology), 28-8 (Epitomics) and SP142 (Spring Bioscience), and CAL10 (BioCare). PD-L1 expression was evaluated based on the percentage of tumor cells positive and their intensity graded as negative, weak (1+), moderate (2+), and strong (+3). The scoring was performed by three pathologists and was blinded for clinicopathologic data and antibody clones. Results: We evaluated a total of 29 patients, including 26 patients with TM and 3 with TC. Among the 29 available specimens, 12 had completed PD-L1 expression assessment at the time of submission. PD-L1 expression is present in 75-100% of the evaluated patients. All had positive PD-L1 staining by SP142 and CAL10. Three patients showed strong intensity by CAL10, and one by SP142. E1L3N and 28-8 had positive PD-L1 expression in 9 and 8 patients respectively with weak/moderate intensity. SP142 and CAL10 demonstrated the strongest concordance (R2 = 0.91) but there was significant variation between antibodies (R2 = 0.31-0.91). No correlation was detected between tumor grade and PD-L1 expression. There were focal areas that lacked expression in all of the evaluated specimens. Conclusions: There is increased expression of PD-L1 in TMS. The level of PD-L1 expression varies between the four PD-L1 antibodies. Increased PD-L1 expression provides evidence for the use of PD-L1 inhibitors in TMS. The variable staining highlights the heterogeneity of TMS and challenges in developing predictive biomarker in this cancer.

Citations: Immunohistochemical staining for programmed cell-death ligand 1 (PD-L1) in malignant thymoma and thymic carcinoma. Alexei Shimanovsky, Richard Cartun, Mary Fiel-Gan, Daniza Mandich, Jonathan Earle, Andrew L. Salner, Katrina Collins, Gregory Alan Otterson, and Benjamin F. Chu. Journal of Clinical Oncology 2017 35:15_suppl, e20003-e20003 https://ascopubs.org/doi/abs/10.1200/JCO.2017.35.15_suppl.e20003

Biocare Announces Strategic Investment from Excellere Partners

Excellere Partners has made an investment in Pacheco, California-based Biocare Medical, a provider of immunohistochemistry instrumentation, as well as a full range of reagents for IHC and molecular testing. No financial terms were disclosed.

PRESS RELEASE

Denver, CO, August 25, 2017 – Excellere Partners, a Denver-based private equity firm focused on partnering with entrepreneurs and management teams, announced today that it has made a strategic investment in Biocare Medical (“Biocare”), a leading provider of immunohistochemistry (IHC) instrumentation, as well as a full range of reagents for IHC and molecular testing. The Biocare partnership represents the first platform investment in Excellere Capital Fund III, L.P.

An innovator in the sector, Biocare is a market leader in simultaneous Multiplex IHC tests, which provide increased confidence at critical diagnostic decision points, improving patient therapy while accelerating turnaround time. “We’re thrilled to have the opportunity to partner with Roy Paxton Yih and the entire Biocare team, and are excited to support their vison for building a best-in-class industry leader focused on IHC and molecular diagnostic products,” said Ryan Glaws, Partner at Excellere. “We identified the reagents and diagnostics products sector several years ago as an attractive area in which to execute Excellere’s value creation strategy. We have dedicated significant resources to pursuing a reagent platform that has a differentiated product offering, global customer base, commitment to R&D, and a passionate leadership team. In Biocare, we have found both an exceptional business as well as a proven management team,” continued Mr. Glaws.

Biocare’s partnership with Excellere will provide the strategic and financial resources to enhance and accelerate the company’s growth opportunities. To this end, Biocare management and Excellere intend to implement a multi-faceted growth strategy comprised of foundational investments that further enhance Biocare’s scalable infrastructure; identified organic growth initiatives in existing and new markets; and complementary strategic partnerships with other leading reagent and diagnostic businesses.

“We have an outstanding opportunity to partner with Excellere, which has a proven track record of supporting founder-led businesses in achieving transformative growth. Over the last 20 years we have not only built a strong and growing company, but more importantly, have developed innovative products that enhance the disease diagnosis and monitoring process andultimately save lives. While we had many options, we chose Excellere as our partner based on their track record and passion for supporting emerging growth companies. We believe that our product suite and service model uniquely position Biocare to meet the evolving demands of clinicians and researchers across the globe,” said Roy Paxton Yih, Biocare co-founder and Chief Executive Officer.

“This partnership is perfectly aligned with our firm’s founding philosophy to invest in entrepreneurial healthcare businesses that are patient-centric, while also creating value for the clinicians, institutions, and other stakeholders in the healthcare ecosystem. Together, Biocare management and Excellere will further strengthen the company’s presence, not only in the U.S., but in other attractive markets by partnering with leading reagent and diagnostic tools businesses as well as expanding the company’s product offering.” Mr. Glaws explained.

About Biocare
Biocare is a market leader in IHC and molecular diagnostic reagents, including simultaneous Multiplex IHC tests that provide increased confidence at critical diagnostic decision points, positively influencing patient therapy while accelerating turnaround time. The company’s customers include clinical and hospital laboratories, pharmaceutical companies, and biotechnology companies as well as academic, government, military, and other nonprofit laboratories. Biocare offers an expanding portfolio of integrated products to address the rapidly growing cancer and infectious disease diagnostic and research markets with novel tissue immunohistochemistry and in situ hybridization methods. The company is headquartered in Pacheco, CA, and has a global distribution network. Visit www.biocare.net to learn more.

About Excellere Partners
Excellere Partners is a Denver-based private equity firm with $1.36 billion of committed capital across Fund I, Fund II and Fund III, specializing in partnering with entrepreneurs and management teams. The firm employs a proven research-driven, top down investment strategy, and supports its entrepreneurs and management teams with a proprietary value creation process designed to enhance corporate and operational infrastructure for scalability and growth. Excellere’s investments are focused on differentiated and growth oriented companies positioned to benefit from industry consolidation and favorable macro-economic and demographic trends. Excellere’s targeted industry sectors include: healthcare services and products; energy, power and infrastructure services and products; industrial technology, specialty chemicals; and business services. For more information about Excellere, please visit http://www.excellerepartners.com

For More Information Visit: https://www.pehub.com/2017/08/excellere-partners-invests-in-biocare-medical/

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.