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Do not freeze.", "Language": "en", "Country": "XG", "Code": "Storage Conditions (Product)" }, { "Name": "Background Information", "Value": "VENTANA PD-L1 (SP142) Assay is an immunohistochemical assay utilizing an anti-PD-L1 rabbit monoclonal primary antibody to recognize the PD-L1 protein. This assay was codeveloped by Roche/Ventana Medical Systems, Inc. (Ventana) and Roche/Genentech to identify patients who are most likely to respond to treatment with TECENTRIQ® (atezolizumab).

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.1 Ligation 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.1,2 B7.1 is a molecule expressed on antigen presenting cells and activated T cells.1,2 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.2 PD-L1 expression has been observed in immune cells and malignant cells and aberrant expression of PD-L1 on tumor cells (TC) has been reported to impede anti-tumor immunity, resulting in immune evasion.1,3 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. The association between PD-L1 expression in tumor cells or tumor-infiltrating immune cells (IC) and clinical benefit with PD-L1/PD-1 pathway inhibitors has been reported across multiple cancers.3-10

Atezolizumab is an Fc-engineered, humanized, monoclonal antibody that binds to PD-L1 and blocks interactions with the PD-1 and B7.1 receptors.3-10 Atezolizumab is a nonglycosylated IgG1 kappa immunoglobulin that has a calculated molecular mass of 145 kDa.

References 
  1. 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.
  2. 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.
  3. Herbst RS, Soria JC, Kowanetz M, et al. Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature. 2014;515(7528):563-567.
  4. Bellmunt J, Mullane SA, Werner L, et al. Association of PD-L1 expression on tumor-infiltrating mononuclear cells and overall survival in patients with urothelial carcinoma. Ann Oncol. 2015;26(4):812-817.
  5. Brahmer JR, Drake CG, Wollner I, et al. Phase I study of single-agent anti-programmed death-1 (MDX-1106) in refractory solid tumors: safety, clinical activity, pharmacodynamics, and immunologic correlates. J Clin Oncol. 2010;28(19):3167-3175.
  6. Fehrenbacher L, Spira A, Ballinger M et al. Atezolizumab versus docetaxel for patients with previously treated non-small-cell lung cancer (POPLAR): a multicentre, open-label, phase 2 randomised controlled trial. Lancet. 2016;387(10030):1837-1846.
  7. Powles T, Eder JP, Fine GD, et al. MPDL3280A (anti-PD-L1) treatment leads to clinical activity in metastatic bladder cancer. Nature. 2014;515(7528):558-562.
  8. Rosenberg JE, Hoffman-Censits J, Powles T, et al. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial. Lancet. 2016;387(10031):1909–20.
  9. Topalian SL, Hodi FS, Brahmer JR, et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med. 2012;366(26):2443-2454.
  10. Schmid P, Adams S, Rugo HS, et al. Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer. N Engl J Med. 2018;379(22):2108-2121. 
  11. Carson F, Hladik C. Histotechnology: A Self Instructional Text, 3rd edition. Hong Kong: American Society for Clinical Pathology Press; 2009.
  12. Roche PC, Hsi ED. Immunohistochemistry-Principles and Advances. Manual of Clinical Laboratory Immunology, 6th edition. In: NR Rose, ed. ASM Press; 2002.
  13. Occupational Safety and Health Standards: Occupational exposure to hazardous chemicals in laboratories. (29 CFR Part 1910.1450). Fed. Register.
  14. Directive 2000/54/EC of the European Parliament and Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work.
  15. Anatomic Pathology Checklist. College of American Pathologists. Jul 28, 2015.
  16. CLSI. Quality assurance for design control and implementation of immunohistochemistry assay: approved guidelines. 2nd edition Wayne, PA, USA: Clinical and Laboratory Standards Institute; 2011.
  17. Herman GE, Elfont EA. The taming of immunohistochemistry: the new era of quality control. Biotech Histochem. 1991;66(4):194-199.
  18. Hautzer NW, Wittkuhn JF, McCaughey WT. Trypsin digestion in immunoperoxidase staining. J Histochem Cytochem. 1980;28(1):52-53.
  19. Omata M, Liew CT, Ashcavai M, Peters RL. Nonimmunologic binding of horseradish peroxidase to hepatitis B surface antigen. A possible source of error in immunohistochemistry. Am J Clin Pathol. 1980;73(5):626-632.
  20. Nadji M, Morales AR. Immunoperoxidase: part 1. The technique and its pitfalls. Lab Med. 1983;14:767.
", "Language": "en", "Country": "XG", "Code": "Background Information" }, { "Name": "Content", "Value": "VENTANA PD-L1 (SP142) Assay contains sufficient reagent for 50 tests.

One 5 mL dispenser of VENTANA PD-L1 (SP142) Assay contains approximately 36 μg of a rabbit monoclonal antibody.

The antibody is diluted in Tris buffered saline, EDTA, Brij-35 with carrier protein and 0.05% sodium azide, a preservative.

Specific antibody concentration is approximately 7 μg/mL.

VENTANA PD-L1 (SP142) Assay contains a recombinant rabbit monoclonal antibody produced as purified cell culture supernatant.

Refer to the appropriate interpretation guide for detailed instructions for interpretation of VENTANA PD-L1 (SP142) Assay staining in specific indications:
  • VENTANA PD-L1 (SP142) Assay Interpretation Guide for Urothelial Carcinoma (P/N 1015704)
  • VENTANA PD-L1 (SP142) Assay Interpretation Guide for NSCLC ≥ 50% TC or ≥ 10% IC Stepwise Scoring Algorithm (P/N 1015703)
  • VENTANA PD-L1 (SP142) Assay Interpretation Guide for NSCLC ≥ 1% TC or ≥ 1% IC Stepwise Scoring Algorithm (P/N 1015654)
  • VENTANA PD‑L1 (SP142) Assay Interpretation Guide for TNBC (P/N 1018231)

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 (SP142) Assay utilizes a rabbit monoclonal primary antibody that binds to PD-L1 in paraffin-embedded tissue sections. The specific antibody can be visualized using OptiView DAB IHC Detection Kit (Cat. No. 760-700 / 06396500001) followed by the OptiView Amplification Kit (Cat. No. 760-099 / 06396518001 (50 test) or 860-099 / 06718663001 (250 test)). Refer to the appropriate method sheets for further information.", "Language": "en", "Country": "XG", "Code": "Principle" } ] } } ] }

VENTANA PD-L1 (SP142) Assay

CE

IVD For in vitro diagnostic use.
PD-L1 SP142 Assay
Guiding immunotherapy decisions

VENTANA PD-L1 predictive assays identify patients who are most likely to respond to specific therapies, generating results you can trust so that you can make timely diagnostic decisions and therapeutic choices. 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 (SP142) Assay* gives you the confidence to:

  • Identify triple–negative breast cancer (TNBC) patients eligible for treatment with TECENTRIQ® (atezolizumab)
  • Identify urothelial carcinoma (UC) patients eligible for treatment with TECENTRIQ® (atezolizumab)
  • Identify non-small cell lung cancer (NSCLC) patients eligible for treatment with TECENTRIQ® (atezolizumab)

* VENTANA PD-L1 (SP142) Assay may not be available for some indications and/or cutoffs in all geographies. In Switzerland TECENTRIQ is approved for non-small cell lung cancer only.

Companion diagnostic indications

Triple-negative breast cancer, urothelial carcinoma and non-small cell lung cancer

Using the right test to determine PD-L1 status for immunotherapy options is important. VENTANA PD-L1 (SP142) Assay* is the first and only CE-IVD marked test for TECENTRIQ in triple–negative breast cancer (TNBC) and urothelial carcinoma (UC) and non-small cell lung cancer (NSCLC) patients. This novel assay is also the first to evaluate patient PD-L1 expression using immune cell staining and scoring within the tumor microenvironment, providing you with information that can guide immunotherapy decisions.

VENTANA PD-L1 (SP142) Assay:

  • Designed to enhance visual contrast of immune cell staining  within the tumor microenvironment
  • First PD-L1 assay CE-IVD marked with an immune cell scoring algorithm
  • First and only PD-L1 assay clinically proven to identify patients eligible for and most likely to benefit from TECENTRIQ
Complementary diagnostic indications

Non-small cell lung cancer (NSCLC)

Using the right test to determine PD-L1 status for immunotherapy options is important, and the VENTANA PD-L1 (SP142) Assay is the only CE-IVD marked test for TECENTRIQ. This innovative assay is the first to evaluate patient PD-L1 expression using both tumor cell (TC) and tumor-infiltrating immune cell (IC) staining. Determining a patient’s PD-L1 expression level can give insight to the overall survival that may be achieved from TECENTRIQ.*

VENTANA PD-L1 (SP142) Assay:

  • Only CE-IVD marked test to assess NSCLC patient treatment benefit from TECENTRIQ
  • Informative for the clinician of a patient’s potential overall survival
  • Novel scoring algorithm using PD-L1 staining in both TC and IC
  • Designed to enhance visual contrast of immune cell staining within the tumor microenvironment

*All randomized patients in a NSCLC phase III study observed benefit from TECENTRIQ regardless of PD-L1 status.

Product specifications

VENTANA PD-L1 (SP142) Assay is intended for the immunohistochemical assessment of the programmed death-ligand 1 (PD-L1) protein in tumor cells and tumor-infiltrating immune cells in formalin-fixed, paraffin-embedded (FFPE) tissues indicated below stained with OptiView DAB IHC Detection Kit and OptiView Amplification Kit on a BenchMark IHC/ISH instrument.

Determination of PD-L1 status is indication-specific and evaluation is based on either the proportion of tumor area occupied by PD-L1 expressing tumor-infiltrating immune cells (% IC) of any intensity or the percentage of PD-L1 expressing tumor cells (% TC) of any intensity.

VENTANA PD-L1 (SP142) Assay companion diagnostic indications

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VENTANA PD-L1 (SP142) Assay companion diagnostic indications

VENTANA PD-L1 (SP142) Assay is indicated as an aid for identifying patients for treatment with the therapies listed in this table for the respective indications and cutoffs in accordance with the approved therapeutic product labeling.

VENTANA PD-L1 (SP142) Assay is indicated as an aid for identifying patients for treatment with the therapies listed in this table for the respective indications and cutoffs in accordance with the approved therapeutic product labeling.

Indication for use Therapy
Cutoff
Urothelial Carcinoma
TECENTRIQ*
≥ 5% IC
Triple–Negative Breast Carcinoma (TNBC)
TECENTRIQ* ≥ 1% IC
Non-Small Cell Lung Cancer (NSCLC) TECENTRIQ* ≥ 50% TC or ≥ 10% IC

VENTANA PD-L1 (SP142) Assay complementary diagnostic indication

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VENTANA PD-L1 (SP142) Assay complementary diagnostic indication

VENTANA PD-L1 (SP142) Assay may be associated with enhanced patient benefit with the therapies listed in this table for the corresponding indication and cutoffs in accordance with the approved therapeutic product labeling.

VENTANA PD-L1 (SP142) Assay may be associated with enhanced patient benefit with the therapies listed in this table for the corresponding indication and cutoffs in accordance with the approved therapeutic product labeling.

Indication for use Therapy
Cutoff
Non-small Cell Lung Cancer (NSCLC) TECENTRIQ* ≥ 50% TC or ≥ 10% IC
Non-small Cell Lung Cancer (NSCLC) TECENTRIQ* ≥ 1% TC or ≥ 1% IC

References

 

* The international non-proprietary name (INN) for TECENTRIQ is atezolizumab.

Depending on therapeutic setting, PD-L1 expression in ≥ 50% TC or ≥ 10% IC determined by VENTANA PD-L1 (SP142) Assay in non-small cell lung cancer (NSCLC) patients may be associated with enhanced overall survival from TECENTRIQ (atezolizumab). Refer to the approved therapeutic product labeling for further information.

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

This product is intended for in vitro diagnostic (IVD) use.

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