Biocare Medical Launches 7 Novel IVD Antibodies for Clinical Diagnostic and Cancer Research Applications with a Focus on Immuno-Oncology

SAN FRANCISCO, Feb. 20, 2020 /PRNewswire/ -- Biocare Medical, a leading provider of innovative, automated immunohistochemistry (IHC) reagents and instrumentation, announces the launch of seven novel IVD IHC antibody markers for clinical diagnostics and research applications. The most recent launch focuses on several immuno-oncology markers, critical in aiding early-stage cancer drug developments and patient treatment.

Biocare re-developed a major antibody marker (S100 Protein), which is expressed in Schwannomas, ependymomas, astrogliomas, and nearly all melanomas (benign and malignant) and their metastases. Biocare's new marker, S100 [4C4.9], lends a stronger and more robust staining signal for IHC applications vs. previous offerings.

Biocare also releases one mouse monoclonal and five novel rabbit monoclonal antibodies in the immuno-oncology space. Recombinant rabbit monoclonal antibodies are ideal for research applications for use with Multiplex IHC technologies and are not reliant upon hybridomas that may expire. CTLA-4 [CAL49], GITR [CAL8], LAG3 [CAL26], PD-1 [CAL20], CD22 (M) [BLCAM/1796], and E-Cadherin [CDH1/2208R] are now commercially available.

CTLA-4 - Ipilimumab, the first immunotherapeutic drug directed toward CTLA-4 inhibition, has demonstrated overall survival benefit in metastatic melanoma. Another CTLA-4 inhibitor, tremelimumab (IgG2 isotype), has also proven successful in metastatic melanoma and other malignancies^1,2.

GITR - GITR modulation in preclinical models has shown promising antitumor activity via significant increase in effector T cells and decrease in Tregs³. Several human monoclonal antibodies that agonize GITR are currently undergoing phase I clinical studies in various solid malignancies. Preliminary results demonstrate an acceptable safety profile without dose limiting toxicities^4-5.

LAG3 - Recent studies in a metastatic ovarian cancer mouse model showed that LAG-3 blockade leads to upregulation of other immune checkpoints (PD-1, CTLA4, and TIM-3), and combination therapy targeting LAG-3, PD-1, and CTLA-4 increases functional cytotoxic T cell levels while reducing Tregs and myeloid-derived suppressor cells^6,7.

PD-1 - Treatments targeting PD-1 and its ligand, PD-L1, have also shown encouraging results in melanoma, non-small-cell lung cancer, and renal cell carcinoma^8-10. This antibody can also be used in multiplex stains with other antibodies such as CD4, CD8, FOXP3, cytokeratin, and melanoma markers¹¹.

CD22 (M) - May be a useful marker for phenotyping mature leukemias, as CD22 membrane expression has been shown to be limited to the late differentiation stages between mature B cells (CD22+) and plasma cells (CD22-)^{12, 13}. CD22 is also strongly expressed in hairy cell leukemia¹⁴.

E-cadherin - A decreased expression of E-cadherin is associated with metastatic potential and poor prognosis in breast cancer, prostate, and esophageal cancer. 

"We are proud to be able to launch novel, IVD IHC markers that meet the highest standards in cancer diagnostics. This commitment to quality ensures Biocare is providing the best diagnostic and research utility possible," said Dr. Jason Ramos, Vice President – Reagent Research and Development at Biocare Medical.

The new product launches continue Biocare Medical's long-standing history of providing novel, high-quality reagents to customers looking to advance their research and diagnostic efficiency in the laboratory.

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, intelliPATH™ and VALENT™, have been designed to meet every need from high throughput clinical diagnostics to flexible research requirements.

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Biocare Medical
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1. Buchbinder EI, McDermott DF. Cytotoxic T-lymphocyte antigen-4 blockade in melanoma. Clinical Therapeutics. 2015; 37:755-63.  2. Baecher-Allan C, et al. Human CD4+CD25+ regulatory T cells. Semin Immunol. 2004 Apr; 16(2):89-98. 3. Dempke WCM, et al. Second- and third-generation drugs for immunooncology treatment-The more the better? Eur J Cancer. 2017; 74:55– 72. 4. Center for Disease Control Manual. Guide: Safety Management, NO. CDC-22, Atlanta, GA. April 30, 1976 "Decontamination of Laboratory Sink Drains to Remove Azide Salts." 5. Clinical and Laboratory Standards Institute (CLSI). Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline-Fourth Edition CLSI document M29-A4 Wayne, PA 2014. 6. Huang RY, et al. LAG3 and PD1 co-inhibitory molecules collaborate to limit CD8+ T cell signaling and dampen antitumor immunity in a murine ovarian cancer model. Oncotarget. 2015; 6:27359-77. 7. Huang RY, et al. Compensatory upregulation of PD-1, LAG-3, and CTLA-4 limits the efficacy of single-agent checkpoint blockade in metastatic ovarian cancer. Oncoimmunology. 2017; 6:e1249561. 8. Tumeh PC, et al. PD-1 blockade induces responses by inhibiting adaptive immune resistance. Nature. 2014 Nov 27; 515(7528):568-71. 9. D'Incecco A, et al. PD-1 and PD-L1 expression in molecularly selected non-small cell lung cancer patients. Br J Cancer. 2015 Jan 6; 112(1):95-102. 10. Tykodi SS. PD-1 as an emerging therapeutic target in renal cell carcinoma: current evidence. Onco Targets Ther. 2014 Jul 25; 7:1349-59. 11. Yang G, et al. A multiplex IHC evaluation of multiple immune checkpoint receptors and mismatch repair proteins in colorectal carcinoma [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr 1026. 12. Perfetti V, et al. Membrane CD22 defines circulating myeloma-related cells as mature or later B cells. Lab Invest. 1997 Oct;77(4):333-44. 13. Batata A, Shen B. Immunophenotyping of subtypes of B-chronic (mature) lymphoid leukemia. A study of 242 cases. Cancer. 1992 Nov 15;70(10):2436-43. 14. Voigt JJ, et al. Immunochemical diagnosis of hepatic localizations in malignant lymphoid hematologic disease. Study of 80 cases. Gastroenterol Clin Biol. 1989 Apr;13(4):343-52.

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