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Roche VENTANA IHC lung cancer portfolio

Our growing portfolio of IHC sensitive and specific assays is here to aid you in the in the stratification of lung cancers.
Deliver diagnostic confidence with the lung IHC portfolio

The statistics associated with lung cancer clearly demonstrate the aggressive nature of this deadly disease. Roche Diagnostics offers a robust menu of lung cancer diagnostic tools. Our portfolio of IHC diagnostic assays, IHC staining products, and more, deliver the high sensitivity and specificity you need.

VENTANA prediluted, optimized reagents

Our antibodies are ready to use on the fully automated VENTANA BenchMark IHC/ISH staining platforms, reducing the time-to-result and resources required with manual or semi-automated solutions. VENTANA prediluted, optimized reagents consistently demonstrate superior performance when compared with concentrated antibodies that require manual dilution and in-house validation.

Proven portfolio of lung cancer assays

Our proven portfolio of lung cancer assays can assist in the stratification of disease, including non-small cell lung carcinoma (NSCLC), neuroendocrine carcinoma, and their various subtypes.

VENTANA ALK (D5F3) CDx assay

 

  • ALK (D5F3) Assay stained with OptiView DAB IHC Detection and Amplification kits detects the ALK protein that is the target of therapy
  • Clinical guidelines recommend rapid turnaround for earlier targeted therapies
  • ALK has comparable sensitivity and specificity relative to FISH
  • More immediate treatment decisions can be made for advanced NSCLC patients by using the ALK (D5F3) Assay 
  • VENTANA ALK (D5F3) CDx Assay is intended for the qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung carcinoma (NSCLC) tissue stained with a BenchMark XT or BenchMark ULTRA automated staining instrument. It is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib), ZYKADIA® (ceritinib), ALECENSA® (alectinib) or LORBRENA® (lorlatinib).1,2,3,4
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VENTANA ALK (D5F3) CDx Immunohistochemistry assay
VENTANA PD-L1(SP263) Assay

 

  • Identify non-small cell lung cancer (NSCLC) patients eligible for treatment with TECENTRIQ in early stage NSCLC®14.
  • Identify non-small cell lung cancer (NSCLC) patients eligible for treatment with LIBTAYO (cemiplimab-rwlc) in locally advanced or metastatic NSCLC16.
  • PD-L1 is an informative immunotherapy biomarker.
  • Aberrant expression of PD-L1 on tumor cells and immune cells in the tumor microenvironment impedes anti-tumor immunity, allowing tumors to grow and metastasise.
Learn more
VENTANA PD-L1 (SP263) Assay
VENTANA PD-L1(SP142) Assay

 

  • Identify non-small cell lung cancer (NSCLC) patients eligible for TECENTRIQ®14
  • PD-L1 is an informative immunotherapy biomarker
  • Aberrant expression of PD-L1 on tumor and immune cells in the tumor microenvironment impedes anti-tumor immunity, allowing tumors to grow and metastasize
Learn more
VENTANA PD-L1(SP142) Assay
VENTANA ROS1 (SP384) Rabbit Monoclonal Primary Antibody
VENTANA ROS1 (SP384) Rabbit Monoclonal Primary Antibody

 

  • The first and only pre-optimized, ready-to-use IVD IHC ROS1assay on the market
  • Highly correlated to FISH break-apart status (92.5% OPA)1
  • High correlation between pathologists (96.4% OPA)2
anti-p40 (BC28) Mouse Monoclonal Primary Antibody
p40 (BC28) Mouse Monoclonal Primary Antibody

 

  • Found to be as or more sensitive than p63,3,4,5
  • Studies indicate p40 has higher specificity in squamous cell carcinoma than p633,4,5
  • May offer a suitable replacement for p63 in various tumor types6,7
  • Can be used in a stratification panel with other key markers8,9
TTF-1 (SP141) Rabbit Monoclonal Primary Antibody
TTF-1 (SP141) Rabbit Monoclonal Primary Antibody

 

  • Aids in investigation of metastatic carcinomas of unknown origin10
  • Commonly used in lung stratification panels with other key markers8,9
Cytokeratin 5/6 (D5/16B4) Mouse Monoclonal Primary Antibody
Cytokeratin 5/6 (D5/16B4) Mouse Monoclonal Primary Antibody

 

  • Aids in the identification of squamous cell carcinoma11
  • Aids in the differentiation of malignant mesothelioma from lung adenocarcinoma12
  • Commonly used in a stratification panel with other markers8,9
Napsin A (MRQ-60) Mouse Monoclonal Primary Antibody
Napsin A (MRQ-60) Mouse Monoclonal Primary Antibody

 

  • Useful in the identification of primary and metastatic carcinomas of the lung13
  • Highly specific for lung adenocarcinoma8
  • Commonly used in a lung stratification panel with other key markers8,9

Tissue Diagnostics Reagent Catalog

 
IHC and ISH reagents and ancillaries
 
To view associated reagents, ancillaries and bulks, please visit the Roche Tissue Diagnostics reagent catalog.
 

View reagent catalog

 

Tissue Diagnostics Reagent Catalog
References
  1. Huang, R. et al. P2.09-13 Correlation of ROS1 (SP384) Immunohistochemistry with ROS1 Rearrangement Determined by Fluorescence In Situ Hybridization. IASLC 2018 19th World Conference on Lung Cancer Abstracts. https://wclc2018.iaslc.org/wp-content/uploads/2018/09/WCLC2018-Abstract-Book_vF-LR-REV-SEPT-25-2018.pdf Accessed 6th March, 2019. 
  2. Hanlon Newell, A. et al. MA26.07 ROS1 (SP384) Immunohistochemistry Inter-Reader Precision Between 12 Pathologists. IASLC 2018 19th World Conference on Lung Cancer Abstracts. https://wclc2018.iaslc.org/wp-content/uploads/2018/09/WCLC2018-Abstract-Book_vF-LR-REV-SEPT-25-2018.pdf Accessed 6th March, 2019.
  3. Bishop, Justin A, Julie Teruya-Feldstein, William H Westra, Giuseppe Pelosi, William D Travis and Natasha Rekhtman. p40 (∆Np63) is superior to p63 for the diagnosis of pulmonary squamous cell carcinoma. Modern Pathology. 2012 Mar;25(3):405-15.
  4. USCAP 2013 Poster 102 The Role of p40 immunostain in the Cytological Differential Diagnosis of Squamous Cell Carcinoma and Adenocarcinoma of the Lung (351)X Chen, Y Bao, R Wong, K Politi, L Jiao, S Gettinger, R Homer, D Chhieng, G Cai - Yale School of Medicine, New Haven, CT http://uscapknowledgehub.org/index.htm?102nd/postii3.htm
  5. USCAP 2013 Poster 100 p40 (DNp63): A Highly Sensitive and Specific Immunohistochemical (IHC) Marker for Diagnosing Pulmonary Squamous Cell Carcinomas (SQCC) in Fine Needle Aspirates (436) AP Vogt, C Cohen, MT Siddiqui - Emory University School of Medicine, Atlanta, GA http://uscapknowledgehub.org/index.htm?102nd/postii3.htm
  6. Tacha, David PhD; Ryan Bremer, PhD; Thomas Haas, DO; Weiman Qi, PhD, MD. An Immunohistochemical Analysis of a Newly Developed, Mouse Monoclonal p40 (BC28) Antibody in Lung, Bladder, Skin, Breast, Prostate and Head and Neck Cancers. Arch Pathol Lab Med—Vol 138, October 2014.
  7. Sailer et al. Comparison of p40 (DNp63) and p63 expression in prostate tissues – which one is the superior diagnostic marker for basal cells? Histopathology. 2013. 63: 50–56.
  8. Wei Zhao, Hui Wang, Yan Peng, Bo Tian, Lei Peng, Da-Chuan Zhang. ΔNp63, CK5/6, TTF-1 and napsin A, a reliable panel to subtype non-small cell lung cancer in biopsy specimens. Int J Clin Exp Pathol. 2014; 7(7): 4247–4253.
  9. Kai Zhang, Hongbin Deng, and Philip T. Cagle (2014) Utility of Immunohistochemistry in the Diagnosis of Pleuropulmonary and Mediastinal Cancers: A Review and Update. Archives of Pathology & Laboratory Medicine: December 2014, Vol. 138, No. 12, pp. 1611-1628.
  10. Daniel Misch, Torsten Blum, Christian Boch, Timo Weiss, Catharina Crolow, Sergej Griff, Thomas Mairinger, Torsten T Bauer and Jens Kollmeier. Value of thyroid transcription factor (TTF)-1 for diagnosis and prognosis of patients with locally advanced or metastatic small cell lung cancer. Diagnostic Pathology (2015) 10:21
  11. A. Kargi, D. Gurel, B. Tuna, The diagnostic value of TTF-1, CK 5/6, and p63 immunostaining in classification of lung carcinomas. Appl Immunohistochem Mol Morphol. 2007 Dec;15(4):415-20.
  12. N.G. Ordòñez. Value of cytokeratin 5/6 immunostaining in distinguishing epithelial mesothelioma of the pleura from lung adenocarcinoma. Am J Surg Pathol. 1998 Oct;22(10):1215-21.
  13. Ye J, Findeis-Hosey JJ, Yang Q, McMahon LA, Yao JL, Li F, Xu H. Combination of napsin A and TTF-1 immunohistochemistry helps in differentiating primary lung adenocarcinoma from metastatic carcinoma in the lung. Appl Immunohistochem Mol Morphol. 2011 Jul;19(4):313-7.
  14. TECENTRIQ® (atezolizumab)  [package insert], San Francisco, CA: Genentech.
  15. LORBRENA® (lorlatinib) [package insert] New York, NY: Pfizer: 2021
  16. LIBTAYO(R) (cemiplimab-rwlc) [package insert] Tarrytown, NY: Regeneron Pharmaceuticals Inc.
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