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"Value": "Upon receipt and when not in use, store at 2-8°C. Do not freeze.", "Language": "en", "Country": "XG", "Code": "Storage Conditions (Product)" }, { "Name": "Content", "Value": "VENTANA PD-L1 (SP263) antibody contains sufficient reagent for 50 tests.

One 5 mL dispenser of VENTANA PD-L1 (SP263) antibody contains approximately 8 μg of a rabbit monoclonal antibody.

The antibody is diluted in 0.05 M Tris-HCI with 1% carrier protein, and 0.10% ProClin 300, a preservative.

Specific antibody concentration is approximately 1.6 μg/mL. There is no known nonspecific antibody reactivity observed in this product.

VENTANA PD-L1 (SP263) antibody is a recombinant rabbit monoclonal antibody produced as cell purified culture supernatant.

Refer to the appropriate VENTANA detection kit method sheet for detailed descriptions of: Principle of the Procedure, Material and Methods, Specimen Collection and Preparation for Analysis, Quality Control Procedures, Troubleshooting, Interpretation of Results, and Limitations.", "Language": "en", "Country": "XG", "Code": "Content" }, { "Name": "Background Information", "Value": "VENTANA PD-L1 (SP263) Rabbit Monoclonal Primary Antibody (VENTANA PD-L1 (SP263) antibody) is a rabbit monoclonal primary antibody produced against programmed death-ligand 1 (PD-L1) also known as B7 homolog 1 (B7-H1) or CD274. It recognizes a transmembrane bound glycoprotein that has a molecular mass of 45-55 kDa. This antibody produces membranous and/or cytoplasmic staining.

PD-L1 is a transmembrane protein that downregulates immune responses through binding to its two receptors programmed death-1 (PD-1) and B7-1 (CD80).1 PD-1 is an inhibitory receptor expressed on T cells following T-cell activation, which is sustained in states of chronic stimulation such as in chronic infection or cancer.2 Binding of PD-L1 with PD-1 inhibits T cell proliferation, cytokine production, and cytolytic activity, leading to the functional inactivation or exhaustion of T cells. CD80 is a molecule expressed on antigen presenting cells and activated T cells. PD-L1 binding to CD80 on T cells and antigen presenting cells can mediate downregulation of immune responses, including inhibition of T-cell activation and cytokine production.3 PD-L1 expression has been observed in immune cells and tumor cells.4,5 Aberrant expression of PD-L1 on tumor cells and tumor associated immune cells has been reported to impede anti-tumor immunity, resulting in immune evasion.2,5 Therefore, interruption of the PD-L1/PD-1 pathway represents an attractive strategy to reinvigorate tumor-specific T cell immunity suppressed by the expression of PD-L1 in the tumor microenvironment.

PD-L1 is expressed in a broad range of cancers including lung, melanoma, urothelial, ovarian, and colorectal cancer. Prevalence of PD-L1 expression has been reported from 12% to 100% depending on the tumor type, anti PD-L1 clone and cutoff for positivity.6

References

  1. Keir ME, Butte MJ, Freeman GJ, et al. PD-1 and its ligands in tolerance and immunity. Annu Rev Immunol. 2008;26:677-704.
  2. Blank C, Mackensen A. Contribution of the PD-L1/PD-1 pathway to T-cell exhaustion: an update on implications for chronic infections and tumor evasion. Cancer Immunol Immunother. 2007;56(5):739-745.
  3. Butte MJ, Keir ME, Phamduy TB, et al. Programmed death-1 ligand 1 interacts specifically with the B7-1 costimulatory molecule to inhibit T-cell responses. Immunity. 2007;27(1):111-122.
  4. Dong H, Zhu G, Tamada K, Chen L. B7-H1, a third member of the B7 family, co-stimulates T-cell proliferation and interleukin-10 secretion. Nat Med. 1999;5(12):1365-1369.
  5. Massard C, Gordon MS, Sharma S, et al. Safety and efficacy of durvalumab (MEDI4736), an anti-programmed cell death ligand-1 immune checkpoint inhibitor, in patients with advanced urothelial bladder cancer. J Clin Oncol. 2016;34(26):3119-3125.
  6. Patel SP, Kurzrock R. PD-L1 Expression as a Predictive Biomarker in Cancer Immunotherapy. Mol Cancer Ther. 2015;14(4):847-856.
  7. Carson F, Hladik C. Histotechnology: A Self Instructional Text, 3rd edition. Hong Kong: American Society for Clinical Pathology Press; 2009.
  8. Roche PC, Hsi ED. Immunohistochemistry-Principles and Advances. Manual of Clinical Laboratory Immunology, 6th edition. In: NR Rose, ed. ASM Press; 2002.
", "Language": "en", "Country": "XG", "Code": "Background Information" }, { "Name": "Intended Use", "Value": "VENTANA PD-L1 (SP263) Rabbit Monoclonal Primary Antibody is intended for laboratory use in the detection of the PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) tissue. It is intended to be stained with BenchMark IHC/ISH instruments. It is indicated as an aid in the assessment of PD-L1 expression in human tissues.

This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.

This antibody is intended for in vitro diagnostic (IVD) use.", "Language": "en", "Country": "XG", "Code": "Intended Use" }, { "Name": "Principle", "Value": "VENTANA PD-L1 (SP263) antibody is a rabbit monoclonal primary antibody which binds to PD-L1 in paraffin-embedded tissue sections. The specific antibody can be localized using a haptenated secondary antibody followed by a multimer anti-hapten-HRP conjugate (OptiView DAB IHC Detection Kit, Cat. No. 760-700 / 06396500001). The specific antibody-enzyme complex is then visualized with a precipitating enzyme reaction product. Each step is incubated for a precise time and temperature. At the end of each incubation step, the BenchMark IHC/ISH instrument washes the sections to stop the reaction and to remove unbound material that would hinder the desired reaction in subsequent steps. It also applies LCS (Cat. No. 650-210 / 05424534001 for BenchMark ULTRA and Cat. No. 650-010 / 05264839001 for BenchMark GX and XT), which minimizes evaporation of the aqueous reagents from the specimen slide.

In addition to staining with VENTANA PD-L1 (SP263) antibody, a second slide should be stained with Rabbit Monoclonal Negative Control Ig (Cat. No. 790-4795 / 06683380001). The negative reagent control is used to assess background staining.", "Language": "en", "Country": "XG", "Code": "Principle" }, { "Name": "Product Purpose", "Value": "VENTANA PD-L1 (SP263) Rabbit Monoclonal Primary Antibody is intended for laboratory use in the detection of the PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) tissue. It is intended to be stained with BenchMark IHC/ISH instruments. It is indicated as an aid in the assessment of PD-L1 expression in human tissues.

This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.

This antibody is intended for in vitro diagnostic (IVD) use.", "Language": "en", "Country": "XG", "Code": "Product Purpose" } ] } } ] }

VENTANA PD-L1 (SP263) Rabbit Monoclonal Primary Antibody

IVD For in vitro diagnostic use.
VENTANA PD-L1 (SP263) Rabbit Monoclonal Primary Antibody

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