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Do not freeze.", "Language": "en", "Country": "XG", "Code": "Storage Conditions (Product)" }, { "Name": "Intended Use", "Value": "Refer to the corresponding VENTANA PD-L1 (SP263) Assay package insert for the detailed intended use of this product.
Note: Use of this diagnostic with indicated therapies may not be approved in all countries. Please consult your local Roche representative for local approvals.", "Language": "en", "Country": "XG", "Code": "Intended Use" }, { "Name": "Background Information", "Value": "VENTANA PD-L1 (SP263) Assay is an immunohistochemical (IHC) assay utilizing an antiPD-L1 rabbit monoclonal primary antibody (VENTANA PD-L1 [SP263]) to recognize the programmed death ligand-1 (PD-L1) protein.

PD-L1 is a transmembrane protein that downregulates immune responses through binding to its two receptors, programmed death-1 (PD-1) and B7-1.¹ 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 Tcell proliferation, cytokine production, and cytolytic activity, leading to the functional inactivation or exhaustion of T-cells.² B7.1 is a molecule expressed on antigen presenting cells and activated T-cells. PD-L1 binding to B7.1 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 malignant cells^4,5 and aberrant expression of PD-L1 on malignant 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 Tcell immunity suppressed by the expression of PD-L1 in the tumor microenvironment.

The association between PD-L1 expression in TC or tumor-infiltrating immune cells (IC) and clinical benefit with PD-L1/PD-1 pathway inhibitors has been reported across multiple cancers.

References

Keir ME, Butte MJ, Freeman GJ, et al. PD-1 and its ligands in tolerance and immunity. Annu Rev Immunol 2008; 26:677-704.
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.
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.
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.
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.

", "Language": "en", "Country": "XG", "Code": "Background Information" }, { "Name": "Content", "Value": "VENTANA PD-L1 (SP263) Assay contains sufficient reagent for 50 tests.

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

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

Specific antibody concentration is approximately 1.61 μg/mL. There is no known non-specific antibody reactivity observed in this product.

VENTANA PD-L1 (SP263) Assay is a recombinant rabbit monoclonal antibody produced as purified cell 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": "Principle", "Value": "VENTANA PD-L1 (SP263) Assay 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 ULTRA 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 ULTRA LCS reagent (Cat. No. 650-210 / 05424534001), which minimizes evaporation of the aqueous reagents from the specimen slide.", "Language": "en", "Country": "XG", "Code": "Principle" }, { "Name": "Product Purpose", "Value": "Refer to the corresponding VENTANA PD-L1 (SP263) Assay package insert for the detailed intended use of this product.
Note: Use of this diagnostic with indicated therapies may not be approved in all countries. Please consult your local Roche representative for local approvals.", "Language": "en", "Country": "XG", "Code": "Product Purpose" } ] } } ] }

VENTANA^® PD-L1 (SP263) Assay

US-FDA

IVD

Guiding immunotherapy decisions

VENTANA PD-L1 (SP263) Assay identifies patients who are most likely to respond to specific therapy, so that you can make informed, efficient treatment decisions that can lead to better clinical outcomes and improved quality of life. We support your expertise by providing you with the tools that you need to successfully implement these assays into your laboratory and interpret them proficiently.

Empowering pathologists to answer PD-L1 questions

VENTANA PD-L1 (SP263) Assay guides immunotherapy decisions by identifying:

Non-small cell carcinoma (NSCLC) patients eligible for treatment with TECENTRIQ^® (atezolizumab)
NSCLC patients eligible for treatment with LIBTAYO^® (cemiplimab)

VENTANA PD-L1 (SP263) Assay further benefits patients by:

Providing robust PD-L1 staining in both tumor cells (TC) and tumor-infiltrating immune cells (IC)*
Allowing optimal lung tissue management through PD-L1 testing of archived unstained slides within 12 months

Reagent and ancillary product information

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VENTANA PD-L1 (SP263) Assay is a qualitative immunohistochemistry assay using rabbit monoclonal anti-PD-L1 clone SP263 intended for use in the assessment of the programmed death ligand-1 (PD-L1) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung carcinoma (NSCLC) tissue specimens by light microscopy. The VENTANA PD-L1 (SP263) Assay is used with the OptiView DAB IHC Detection Kit for staining on the BenchMark ULTRA instrument.

NSCLC:

PD-L1 expression in tumor cell (TC) membrane as detected by VENTANA PD-L1 (SP263) Assay in NSCLC is indicated as an aid in identifying patients for treatment with TECENTRIQ^® (atezolizumab).

PD-L1 expression in tumor cell (TC) membrane as detected by VENTANA PD-L1 (SP263) Assay in NSCLC is indicated as an aid in identifying patients for treatment with LIBTAYO^® (cemiplimab).

Table 1. Therapy and associated indication.

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Indication for use	Therapy	PD-L1 Expression
NSCLC	TECENTRIQ®	≥1 % TC
NSCLC	LIBTAYO®	≥50 % TC

*Please refer to the VENTANA PD-L1 (SP263) Assay method sheet for the full intended use statement and approved therapeutic labeling.

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...

*IC staining with this assay is not used to assess PD-L1 status in NSCLC.

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References

VENTANA® PD-L1 (SP263) Assay

VENTANA PD-L1 (SP263) Assay guides immunotherapy decisions by identifying:

VENTANA PD-L1 (SP263) Assay further benefits patients by:

Related portfolios

Related information

Reagent and ancillary product information

Table 1. Therapy and associated indication.

Table 1. Therapy and associated indication.

You might be interested in

Overview

Detailed Specifications

Ordering Information

Compatible Instruments

Technical Documents

Access Material Data Sheets, Certificates of Analysis, and other product documentation.

VENTANA^® PD-L1 (SP263) Assay