Cancer Awareness – Gallbladder Cancer Facts

Approximately 12,000 men and women in the United States are diagnosed with gallbladder cancer annually, leading to an annual estimated 4,000 deaths.1 Gallbladder and other biliary cancers are comparatively rare in the United States, with about 0.7% of new cancer cases classified as gallbladder, contributing approximately 0.6% of cancer deaths yearly.1 Worldwide, gallbladder and other biliary cancers are the twenty-second most frequently diagnosed cancer and the eighteenth leading cause of cancer death, with an annual estimated 219,400 cases and 165,100 deaths.2

Gallbladder carcinoma (GBC) is predominantly found in women (female to male ratio, 3-4: 1), which may be related to increased incidence of gallstones in women.3 In addition to gallstones and gender, there are other risk factors that may influence the development of GBC:4

• Gallbladder polyps: Growths that may form as a result from an embedded gallstone or inflammation.
• Age:
Most patients diagnosed with GBC are in the sixth or seventh decade of life.
• Ethnicity: In the United States, Hispanic and Native Americans have a higher rate of gallbladder cancer than other ethnic groups.
• Smoking: Tobacco use may elevate the risk of death from gallbladder cancer dose-dependently among both men and women.
• Family history: Family history of GBC slightly increases risk of developing GBC.

GBC is a poor prognosis malignancy since it usually presents at a very advanced stage. Early detection of GBC is often difficult because symptoms mimic benign gallbladder diseases, such as gallstones and biliary colic.5 Differentiation of GBC versus non-malignant gallbladder disease is critical to accurate diagnosis and treatment. There have been many immunomarkers reported to be expressed in GBC and not expressed in normal/benign gallbladder: CA 19-9, CEA, Mucin 5AC, S100P, IMP3, GLUT-1, p53, and CDX2.6,7,8,9

As part of our promise of “Fighting Cancer, One Slide at a Time,” Biocare Medical is proud to offer key high-quality immunohistochemistry (IHC) antibodies that aid in accurate classification of gallbladder and other biliary tumors.

Key Antibodies for Gallbladder and Biliary Cancer

Product Name Clone Catalog Number
CA 19-9 BC/121SLE CM 123; PM 123
Carcinoembryonic Antigen (CEA {M}) COL-1 CM 058; PM 058
Mucin 5AC 45M1 CM 231
S100P N/A ACI 3010; API 3010
IMP3 (RM) EP286 ACI 3180; API 3180
GLUT-1 SPM498 CM 408; PM 408
p53 EP9 CME 298; PME 298; IP 298
p53 Tumor Suppressor Protein DO-7 CM 042; PM 042
CDX2 [BC39] BC39 ACI 3184; API 3184; AVI 3184
CDX2 (RM) EP25 ACI 3144; API 3144

Clinical References:

1. Siegel RL, Miller KD, Jemal A. CA Cancer J Clin. 2017 Jan;67(1):7-30.
2. Bray F, et al. CA Cancer J Clin. 2018 Nov;68(6):394-424.
3. Giang TH, et al. Diagn Pathol. 2012 Jan 27;7:10.
4. https://www.cancer.net/cancer-types/gallbladder-cancer/risk-factors
5. https://www.cancer.org/cancer/gallbladder-cancer/detection-diagnosis-staging
6. Hughes NR, Bhathal PS. J Clin Pathol. 2013 Mar;66(3):212-7.
7. Lin F, Chen ZE, Wang HL. Arch Pathol Lab Med. 2015 Jan;139(1):24-38.
8. Xiong L, et al. J Surg Oncol. 2012 Jan;105(1):97-103.
9. Park SY, et al. Oncol Rep. 2009 Sep;22(3):649-57.

Biocare Achieves ISO 13485:2016 Certification

Biocare Medical has achieved ISO 13485:2016 Certification as of February 20, 2019.

The quality management system is applicable to:

  • Design, manufacture and distribution of in vitro diagnostic (IVD), immunohistochemistry reagents/kits, and design, manufacture, distribution, installation and service of general purposes laboratory equipment medical devices.
  • Additional site1: Manufacture, installation and service
  • Additional site2: Design and manufacture

Download our ISO 13485:2016 Certificate of Registration Here.

BIOCARE MEDICAL UNVEILS THE VALENT® – THE FIRST EVER OPEN, FULLY AUTOMATED IVD STAINING PLATFORM

The VALENT, the Market’s Only Open, Fully Automated IVD Platform that Delivers Industry-Leading Throughput and Quality to Clinical, Pharmaceutical and Research Customers

San Francisco, CA, January 24, 2019 – Biocare Medical, LLC, a leading provider of innovative, automated immunohistochemistry (IHC) instrumentation and reagents, announces the release of the VALENT IVD (in vitro diagnostic) automated staining platform.

VALENT is the industry’s first fully automated, open platform, merging high-throughput and quality staining with a powerful and intuitive user interface. VALENT overcomes the limitations of closed systems with its unique open platform, allowing reagents from multiple sources and providing top-tier IHC results. VALENT transforms clinical, pharmaceutical and research laboratories by providing an easy-to-use fully automated platform, 48-slide capacity, multiplex IHC capability, and high-quality staining.

“We work closely with customers, in all different testing environments, to maintain a deep understanding of their job demands and requirements,” said Morgan Porter, Chief Operating Officer of Biocare Medical. “That’s why we’re so thrilled to introduce the VALENT to the market and provide our customers with the most innovative staining platform available in the industry today.”

“The on-line HIER feature of Biocare’s VALENT enables walkaway freedom for the histotech,” said Cheryl Bodden, Histology Laboratory Manager at USF Health Labs.

Increase Efficiency and Flexibility

With VALENT, the IHC protocol is completely automated; performing fast, non-toxic online deparaffinization and utilizing a novel, patent-pending, continuous antigen retrieval dispense technology. With VALENT, Biocare offers a full line of high quality, ready-to-use reagents that have been optimized for maximum performance supporting convenient load-and-go capability, and ultimately enhancing laboratory workflow. The open platform of VALENT enables users to apply enzyme pre-treatments, antibodies, detections, or chromogens from any source. These combined capabilities significantly increase laboratory efficiency, flexibility and turn-around time; freeing up valuable time and resources.

Break the 30-slide Barrier

VALENT breaks the 30-slide barrier, processing 48 slides simultaneously and supporting unparalleled throughput with minimal hands-on time. VALENT employs a high capacity lithium battery to boost the antigen retrieval process and safeguard staining runs in the event of power loss. By enabling users to process more slides per run, safeguard against power fluctuations and provide onboard backup power, VALENT technicians enjoy peace of mind knowing their runs will be completed on time, every time.

Outpace the Competition

In addition to high-quality results, ease-of-use, increased efficiency, and reduced costs, VALENT offers several key features that enable laboratories to stay ahead in this highly competitive space:

Convenient and Intuitive
VALENT is equipped with an array of automatic sensors, minimizing errors before and during runs. The software has an intuitive user interface, placing frequently used functions in a color-coded block on the main screen. The onboard mixing capability of VALENT allows for a walkaway operation and with a 50µL reagent vial dead volume, it also minimizes precious reagent loss, saving money. The convenience of separating hazardous from non-hazardous waste also reduces disposal costs.

Self-Leveling
A level slide and instrument are critical for reagents to be evenly dispensed, ensuring consistently stained, high-quality IHC results. VALENT utilizes a dual-axis inclinometer which, when combined with motorized legs, allows it to self-level. The electronic inclinometer eliminates the reliance upon traditional, subjective levels while offering traceability for end-user record-keeping and regulatory compliance. With motorized legs that can be height adjusted, VALENT also provides optimal user ergonomics.

Self-Cleaning
VALENT performs several self-cleaning techniques to improve stain quality and reduce valuable time that technicians would otherwise spend cleaning. Automated cleaning processes ensure optimal performance and reduce variability. Automated probe and wash station cleaning, as well as weekly automated cleaning routines, maximize staining results and efficiency.

Simultaneous Multiplex IHC
Biocare Medical is the proven leader in simultaneous Multiplex IHC, allowing for visualization of multiple antigens on a single slide. VALENT is designed with simultaneous Multiplex IHC capability, enabling laboratories to save time, money, and precious patient tissue samples.

VALENT is available for immediate sale domestically and includes world-class training and support from Biocare Medical’s highly skilled Education and Customer Care teams. For more information or to schedule a free demo, please visit: www.biocare.net/VALENT


About Biocare Medical

Biocare Medical is a global leader in solutions for cancer research and diagnostics, providing: world-class reagents, including tissue-conserving simultaneous Multiplex antibody cocktails and detections; renowned Customer Care; and a comprehensive suite of advanced instrumentation for IHC, molecular, and histology testing. Customers include clinical anatomic pathology laboratories, pharmaceutical companies, CROs, and biotechnology companies as well as academic, government, military, and other non-profit laboratories. Biocare’s reagent portfolio includes primary antibodies, Multiplex IHC, and FISH probes for target indications. Biocare also offers a unique line of polymer detections for clinical, human, and animal research that deliver high sensitivity and exceptionally low background. The Company’s advanced platforms of semi and fully-automated instrumentation have been designed to meet every need from high throughput clinical diagnostics to flexible research requirements. Biocare Medical’s corporate headquarters and operations are based in the San Francisco Bay Area with a global distribution network.

E-COMMERCE Now Live!

E-commerce Now Live!

Biocare Medical is excited to announce that our new e-commerce platform is now online! We’ve made some significant changes to our online experience that we hope it will not only improve how you interact with us but save you time as well.

  • Pay by Credit or Debit Card anytime
  • Save Your Payment Method for Future Purchases
  • Flat Rate Shipping, $49 – 2 Day, $59 Standard Overnight
  • Order History – Look up all of your previous orders 24/7 with tracking information
  • Auto Search – search by product title, full or partial catalog number
  • Tax Calculations specific to your account

We look forward to hearing your feedback and hope you enjoy these streamlined features.

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 https://www.excellerepartners.com

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

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.

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:
https://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.