Lung cancer diagnostic solutions

The statistics associated with lung cancer clearly demonstrate the aggressive nature of this deadly disease. Roche Tissue 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.

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. 1


Featured 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.

  • Found to be as or more sensitive than p632,3,4
  • Studies indicate p40 has higher specificity in squamous cell carcinoma than p632,3,4
  • May offer a suitable replacement for p63 in various tumor types5,6
  • Can be used in a stratification panel with other key markers7,8
p40 (BC28) Mouse Monoclonal Primary Antibody  

  • Aids in investigation of metastatic carcinomas of unknown origin9
  • Equal or better lung carcinoid detection than other on-market clones10
  • Commonly used in lung stratification panels with other key markers7,8
TTF-1 (SP141) Rabbit 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 markers7,8
Cytokeratin 5/6 (D5/16B4) Mouse Monoclonal Primary Antibody

  • Useful in the identification of primary and metastatic carcinomas of the lung13
  • Highly specific for lung adenocarcinoma7
  • Commonly used in a lung stratification panel with other key markers7,8
Napsin A (MRQ-60) Mouse Monoclonal Primary Antibody

VENTANA Companion Diagnostics

Through our partnerships with leading pharmaceutical companies, Roche is working at our industry’s forefront to customize therapy to individual patients. Our companion diagnostics portfolio helps you improve diagnostic accuracy, lab efficiency and patient safety.

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Lung disease state portfolio

Our growing portfolio of sensitive and specific assays is here to aid you in the in the stratification of lung cancers.

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Reference List

1. Assessment Run 48 p40 (ΔNp63) NordiQC. Updated 2016, accessed 21 MAR 2017

2. 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.

3. Chen, Xiangbai, Yunhau Bao, Rebecca Wong, Katerina Politi, Lizhuo Jiao, Scott Gettinger, Robert Homer, David Chieng, Guoping Cai. [351] The Role of p40 Immunostain in the Cytological Differential Diagnosis of Squamous Cell Carcinoma and Adenocarcinoma of the Lung. USCAP Abstract. 2013

4. Vogt, Adam P, Cynthia Cohen, Momin T Siddiqui. [436] p40 (ΔNp63): A Highly Sensitive and Specific Immunohistochemical (IHC) Marker for Diagnosing Pulmonary Squamous Cell Carcinomas (SQCC) in Fine Needle Aspirates. USCAP Abstract. 2013.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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

10. Lung cancer diagnostic solutions product brochure (7009A-5)

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. Assessment run 45 ALK. NordiQC. Updated 2015, accessed 21 MAR 2017

Lung cancer publications

Learn what the literature says about Roche lung diagnostic products


Accurate and Economical Detection of ALK Positive Lung Adenocarcinoma with Semiquantitative Immunohistochemical Screening
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Diagnostic value of a novel fully automated immunochemistry assay for detection of ALK rearrangement in primary lung adenocarcinoma
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Combination of conventional immunohistochemistry and qRT-PCR to detect ALK rearrangement.
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Dichotomous ALK-IHC is a better predictor for ALK inhibition outcome than traditional ALK-FISH in advanced non-small cell lung cancer
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VENTANA PD-L1 (SP263) Rabbit Monoclonal Primary Antibody

Quantitative and qualitative characterization of Two PD-L1 clones: SP263 and E1L3N
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Development of a programmed cell death ligand-1 immunohistochemical assay validated for analysis of non-small cell lung cancer and head and neck squamous cell carcinoma.
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VENTANA lung panel primary antibodies

An immunohistochemical comparison of two TTF-1 monoclonal antibodies in atypical squamous lesions and sarcomatoid carcinoma of the lung, and pleural malignant mesothelioma
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Companion diagnostics for lung cancer

The VENTANA ALK (D5F3) CDx Assay

Clinical guidelines recommend routine testing for genetic mutations in all adenocarcinomas, including ALK EML4 gene rearrangement. Rest assured with VENTANA ALK (D5F3) CDx Assay, the highest performing ALK assay in EQA testing,

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The VENTANA PD-L1 Portfolio

VENTANA PD-L1 assays generate results you can trust, so that you can make timely diagnostic decisions and therapeutic choices.

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Lung cancer disease state

Learn about the lung cancer disease state, including global incidence, tissue diagnostics and testing guidelines.

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