Journal article

Correlation of ROS1 Immunohistochemistry With ROS1 Fusion Status Determined by Fluorescence In Situ Hybridization

  • Huang, Richard S. P. From Roche Molecular Solutions, Pleasanton, California (Dr Huang, Mr Smith, Dr Le, Mr Liu, Dr Ordinario, Dr Manohar, Mr Lee, Mr Rajamani, Mr Truong, Dr Jing Li, Ms Choi, Dr Jingchuan Li, Dr Pati, Dr Hanlon Newell, Mr Pate, and Dr Menzl); Institute of Pathology, University Hospital Basel, Basel, Switzerland (Dr Bubendorf); Institute for Pathology, University Hospital, Cologne, Germany (Dr Buettner
  • Smith, Derek From Roche Molecular Solutions, Pleasanton, California (Dr Huang, Mr Smith, Dr Le, Mr Liu, Dr Ordinario, Dr Manohar, Mr Lee, Mr Rajamani, Mr Truong, Dr Jing Li, Ms Choi, Dr Jingchuan Li, Dr Pati, Dr Hanlon Newell, Mr Pate, and Dr Menzl); Institute of Pathology, University Hospital Basel, Basel, Switzerland (Dr Bubendorf); Institute for Pathology, University Hospital, Cologne, Germany (Dr Buettner
  • Le, Catherine H. From Roche Molecular Solutions, Pleasanton, California (Dr Huang, Mr Smith, Dr Le, Mr Liu, Dr Ordinario, Dr Manohar, Mr Lee, Mr Rajamani, Mr Truong, Dr Jing Li, Ms Choi, Dr Jingchuan Li, Dr Pati, Dr Hanlon Newell, Mr Pate, and Dr Menzl); Institute of Pathology, University Hospital Basel, Basel, Switzerland (Dr Bubendorf); Institute for Pathology, University Hospital, Cologne, Germany (Dr Buettner
  • Liu, Wen-Wei From Roche Molecular Solutions, Pleasanton, California (Dr Huang, Mr Smith, Dr Le, Mr Liu, Dr Ordinario, Dr Manohar, Mr Lee, Mr Rajamani, Mr Truong, Dr Jing Li, Ms Choi, Dr Jingchuan Li, Dr Pati, Dr Hanlon Newell, Mr Pate, and Dr Menzl); Institute of Pathology, University Hospital Basel, Basel, Switzerland (Dr Bubendorf); Institute for Pathology, University Hospital, Cologne, Germany (Dr Buettner
  • Ordinario, Ellen From Roche Molecular Solutions, Pleasanton, California (Dr Huang, Mr Smith, Dr Le, Mr Liu, Dr Ordinario, Dr Manohar, Mr Lee, Mr Rajamani, Mr Truong, Dr Jing Li, Ms Choi, Dr Jingchuan Li, Dr Pati, Dr Hanlon Newell, Mr Pate, and Dr Menzl); Institute of Pathology, University Hospital Basel, Basel, Switzerland (Dr Bubendorf); Institute for Pathology, University Hospital, Cologne, Germany (Dr Buettner
  • Manohar, Chitra From Roche Molecular Solutions, Pleasanton, California (Dr Huang, Mr Smith, Dr Le, Mr Liu, Dr Ordinario, Dr Manohar, Mr Lee, Mr Rajamani, Mr Truong, Dr Jing Li, Ms Choi, Dr Jingchuan Li, Dr Pati, Dr Hanlon Newell, Mr Pate, and Dr Menzl); Institute of Pathology, University Hospital Basel, Basel, Switzerland (Dr Bubendorf); Institute for Pathology, University Hospital, Cologne, Germany (Dr Buettner
  • Lee, Michael From Roche Molecular Solutions, Pleasanton, California (Dr Huang, Mr Smith, Dr Le, Mr Liu, Dr Ordinario, Dr Manohar, Mr Lee, Mr Rajamani, Mr Truong, Dr Jing Li, Ms Choi, Dr Jingchuan Li, Dr Pati, Dr Hanlon Newell, Mr Pate, and Dr Menzl); Institute of Pathology, University Hospital Basel, Basel, Switzerland (Dr Bubendorf); Institute for Pathology, University Hospital, Cologne, Germany (Dr Buettner
  • Rajamani, Jaya From Roche Molecular Solutions, Pleasanton, California (Dr Huang, Mr Smith, Dr Le, Mr Liu, Dr Ordinario, Dr Manohar, Mr Lee, Mr Rajamani, Mr Truong, Dr Jing Li, Ms Choi, Dr Jingchuan Li, Dr Pati, Dr Hanlon Newell, Mr Pate, and Dr Menzl); Institute of Pathology, University Hospital Basel, Basel, Switzerland (Dr Bubendorf); Institute for Pathology, University Hospital, Cologne, Germany (Dr Buettner
  • Truong, Huan From Roche Molecular Solutions, Pleasanton, California (Dr Huang, Mr Smith, Dr Le, Mr Liu, Dr Ordinario, Dr Manohar, Mr Lee, Mr Rajamani, Mr Truong, Dr Jing Li, Ms Choi, Dr Jingchuan Li, Dr Pati, Dr Hanlon Newell, Mr Pate, and Dr Menzl); Institute of Pathology, University Hospital Basel, Basel, Switzerland (Dr Bubendorf); Institute for Pathology, University Hospital, Cologne, Germany (Dr Buettner
  • Li, Jing From Roche Molecular Solutions, Pleasanton, California (Dr Huang, Mr Smith, Dr Le, Mr Liu, Dr Ordinario, Dr Manohar, Mr Lee, Mr Rajamani, Mr Truong, Dr Jing Li, Ms Choi, Dr Jingchuan Li, Dr Pati, Dr Hanlon Newell, Mr Pate, and Dr Menzl); Institute of Pathology, University Hospital Basel, Basel, Switzerland (Dr Bubendorf); Institute for Pathology, University Hospital, Cologne, Germany (Dr Buettner
  • Choi, Cindy From Roche Molecular Solutions, Pleasanton, California (Dr Huang, Mr Smith, Dr Le, Mr Liu, Dr Ordinario, Dr Manohar, Mr Lee, Mr Rajamani, Mr Truong, Dr Jing Li, Ms Choi, Dr Jingchuan Li, Dr Pati, Dr Hanlon Newell, Mr Pate, and Dr Menzl); Institute of Pathology, University Hospital Basel, Basel, Switzerland (Dr Bubendorf); Institute for Pathology, University Hospital, Cologne, Germany (Dr Buettner
  • Li, Jingchuan From Roche Molecular Solutions, Pleasanton, California (Dr Huang, Mr Smith, Dr Le, Mr Liu, Dr Ordinario, Dr Manohar, Mr Lee, Mr Rajamani, Mr Truong, Dr Jing Li, Ms Choi, Dr Jingchuan Li, Dr Pati, Dr Hanlon Newell, Mr Pate, and Dr Menzl); Institute of Pathology, University Hospital Basel, Basel, Switzerland (Dr Bubendorf); Institute for Pathology, University Hospital, Cologne, Germany (Dr Buettner
  • Pati, Amrita From Roche Molecular Solutions, Pleasanton, California (Dr Huang, Mr Smith, Dr Le, Mr Liu, Dr Ordinario, Dr Manohar, Mr Lee, Mr Rajamani, Mr Truong, Dr Jing Li, Ms Choi, Dr Jingchuan Li, Dr Pati, Dr Hanlon Newell, Mr Pate, and Dr Menzl); Institute of Pathology, University Hospital Basel, Basel, Switzerland (Dr Bubendorf); Institute for Pathology, University Hospital, Cologne, Germany (Dr Buettner
  • Bubendorf, Lukas From Roche Molecular Solutions, Pleasanton, California (Dr Huang, Mr Smith, Dr Le, Mr Liu, Dr Ordinario, Dr Manohar, Mr Lee, Mr Rajamani, Mr Truong, Dr Jing Li, Ms Choi, Dr Jingchuan Li, Dr Pati, Dr Hanlon Newell, Mr Pate, and Dr Menzl); Institute of Pathology, University Hospital Basel, Basel, Switzerland (Dr Bubendorf); Institute for Pathology, University Hospital, Cologne, Germany (Dr Buettner
  • Buettner, Reinhard From Roche Molecular Solutions, Pleasanton, California (Dr Huang, Mr Smith, Dr Le, Mr Liu, Dr Ordinario, Dr Manohar, Mr Lee, Mr Rajamani, Mr Truong, Dr Jing Li, Ms Choi, Dr Jingchuan Li, Dr Pati, Dr Hanlon Newell, Mr Pate, and Dr Menzl); Institute of Pathology, University Hospital Basel, Basel, Switzerland (Dr Bubendorf); Institute for Pathology, University Hospital, Cologne, Germany (Dr Buettner
  • Kerr, Keith M. From Roche Molecular Solutions, Pleasanton, California (Dr Huang, Mr Smith, Dr Le, Mr Liu, Dr Ordinario, Dr Manohar, Mr Lee, Mr Rajamani, Mr Truong, Dr Jing Li, Ms Choi, Dr Jingchuan Li, Dr Pati, Dr Hanlon Newell, Mr Pate, and Dr Menzl); Institute of Pathology, University Hospital Basel, Basel, Switzerland (Dr Bubendorf); Institute for Pathology, University Hospital, Cologne, Germany (Dr Buettner
  • Lopez-Rios, Fernando From Roche Molecular Solutions, Pleasanton, California (Dr Huang, Mr Smith, Dr Le, Mr Liu, Dr Ordinario, Dr Manohar, Mr Lee, Mr Rajamani, Mr Truong, Dr Jing Li, Ms Choi, Dr Jingchuan Li, Dr Pati, Dr Hanlon Newell, Mr Pate, and Dr Menzl); Institute of Pathology, University Hospital Basel, Basel, Switzerland (Dr Bubendorf); Institute for Pathology, University Hospital, Cologne, Germany (Dr Buettner
  • Marchetti, Antonio From Roche Molecular Solutions, Pleasanton, California (Dr Huang, Mr Smith, Dr Le, Mr Liu, Dr Ordinario, Dr Manohar, Mr Lee, Mr Rajamani, Mr Truong, Dr Jing Li, Ms Choi, Dr Jingchuan Li, Dr Pati, Dr Hanlon Newell, Mr Pate, and Dr Menzl); Institute of Pathology, University Hospital Basel, Basel, Switzerland (Dr Bubendorf); Institute for Pathology, University Hospital, Cologne, Germany (Dr Buettner
  • Marondel, Ivonne From Roche Molecular Solutions, Pleasanton, California (Dr Huang, Mr Smith, Dr Le, Mr Liu, Dr Ordinario, Dr Manohar, Mr Lee, Mr Rajamani, Mr Truong, Dr Jing Li, Ms Choi, Dr Jingchuan Li, Dr Pati, Dr Hanlon Newell, Mr Pate, and Dr Menzl); Institute of Pathology, University Hospital Basel, Basel, Switzerland (Dr Bubendorf); Institute for Pathology, University Hospital, Cologne, Germany (Dr Buettner
  • Nicholson, Andrew G. From Roche Molecular Solutions, Pleasanton, California (Dr Huang, Mr Smith, Dr Le, Mr Liu, Dr Ordinario, Dr Manohar, Mr Lee, Mr Rajamani, Mr Truong, Dr Jing Li, Ms Choi, Dr Jingchuan Li, Dr Pati, Dr Hanlon Newell, Mr Pate, and Dr Menzl); Institute of Pathology, University Hospital Basel, Basel, Switzerland (Dr Bubendorf); Institute for Pathology, University Hospital, Cologne, Germany (Dr Buettner
  • Öz, Ayşim Büge From Roche Molecular Solutions, Pleasanton, California (Dr Huang, Mr Smith, Dr Le, Mr Liu, Dr Ordinario, Dr Manohar, Mr Lee, Mr Rajamani, Mr Truong, Dr Jing Li, Ms Choi, Dr Jingchuan Li, Dr Pati, Dr Hanlon Newell, Mr Pate, and Dr Menzl); Institute of Pathology, University Hospital Basel, Basel, Switzerland (Dr Bubendorf); Institute for Pathology, University Hospital, Cologne, Germany (Dr Buettner
  • Pauwels, Patrick From Roche Molecular Solutions, Pleasanton, California (Dr Huang, Mr Smith, Dr Le, Mr Liu, Dr Ordinario, Dr Manohar, Mr Lee, Mr Rajamani, Mr Truong, Dr Jing Li, Ms Choi, Dr Jingchuan Li, Dr Pati, Dr Hanlon Newell, Mr Pate, and Dr Menzl); Institute of Pathology, University Hospital Basel, Basel, Switzerland (Dr Bubendorf); Institute for Pathology, University Hospital, Cologne, Germany (Dr Buettner
  • Penault-Llorca, Frederique From Roche Molecular Solutions, Pleasanton, California (Dr Huang, Mr Smith, Dr Le, Mr Liu, Dr Ordinario, Dr Manohar, Mr Lee, Mr Rajamani, Mr Truong, Dr Jing Li, Ms Choi, Dr Jingchuan Li, Dr Pati, Dr Hanlon Newell, Mr Pate, and Dr Menzl); Institute of Pathology, University Hospital Basel, Basel, Switzerland (Dr Bubendorf); Institute for Pathology, University Hospital, Cologne, Germany (Dr Buettner
  • Rossi, Giulio From Roche Molecular Solutions, Pleasanton, California (Dr Huang, Mr Smith, Dr Le, Mr Liu, Dr Ordinario, Dr Manohar, Mr Lee, Mr Rajamani, Mr Truong, Dr Jing Li, Ms Choi, Dr Jingchuan Li, Dr Pati, Dr Hanlon Newell, Mr Pate, and Dr Menzl); Institute of Pathology, University Hospital Basel, Basel, Switzerland (Dr Bubendorf); Institute for Pathology, University Hospital, Cologne, Germany (Dr Buettner
  • Thunnissen, Erik From Roche Molecular Solutions, Pleasanton, California (Dr Huang, Mr Smith, Dr Le, Mr Liu, Dr Ordinario, Dr Manohar, Mr Lee, Mr Rajamani, Mr Truong, Dr Jing Li, Ms Choi, Dr Jingchuan Li, Dr Pati, Dr Hanlon Newell, Mr Pate, and Dr Menzl); Institute of Pathology, University Hospital Basel, Basel, Switzerland (Dr Bubendorf); Institute for Pathology, University Hospital, Cologne, Germany (Dr Buettner
  • Newell, Amy Hanlon From Roche Molecular Solutions, Pleasanton, California (Dr Huang, Mr Smith, Dr Le, Mr Liu, Dr Ordinario, Dr Manohar, Mr Lee, Mr Rajamani, Mr Truong, Dr Jing Li, Ms Choi, Dr Jingchuan Li, Dr Pati, Dr Hanlon Newell, Mr Pate, and Dr Menzl); Institute of Pathology, University Hospital Basel, Basel, Switzerland (Dr Bubendorf); Institute for Pathology, University Hospital, Cologne, Germany (Dr Buettner
  • Pate, Greg From Roche Molecular Solutions, Pleasanton, California (Dr Huang, Mr Smith, Dr Le, Mr Liu, Dr Ordinario, Dr Manohar, Mr Lee, Mr Rajamani, Mr Truong, Dr Jing Li, Ms Choi, Dr Jingchuan Li, Dr Pati, Dr Hanlon Newell, Mr Pate, and Dr Menzl); Institute of Pathology, University Hospital Basel, Basel, Switzerland (Dr Bubendorf); Institute for Pathology, University Hospital, Cologne, Germany (Dr Buettner
  • Menzl, Ina From Roche Molecular Solutions, Pleasanton, California (Dr Huang, Mr Smith, Dr Le, Mr Liu, Dr Ordinario, Dr Manohar, Mr Lee, Mr Rajamani, Mr Truong, Dr Jing Li, Ms Choi, Dr Jingchuan Li, Dr Pati, Dr Hanlon Newell, Mr Pate, and Dr Menzl); Institute of Pathology, University Hospital Basel, Basel, Switzerland (Dr Bubendorf); Institute for Pathology, University Hospital, Cologne, Germany (Dr Buettner
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  • 2019-9-11
Published in:
  • Archives of Pathology & Laboratory Medicine. - Archives of Pathology and Laboratory Medicine. - 2019, vol. 144, no. 6, p. 735-741
English
Context.—
The ability to determine ROS1 status has become mandatory for patients with lung adenocarcinoma, as many global authorities have approved crizotinib for patients with ROS1-positive lung adenocarcinoma.


Objective.—
To present analytical correlation of the VENTANA ROS1 (SP384) Rabbit Monoclonal Primary Antibody (ROS1 [SP384] antibody) with ROS1 fluorescence in situ hybridization (FISH).


Design.—
The immunohistochemistry (IHC) and FISH analytical comparison was assessed by using 122 non–small cell lung cancer samples that had both FISH (46 positive and 76 negative cases) and IHC staining results available. In addition, reverse transcription–polymerase chain reaction (RT-PCR) as well as DNA and RNA next-generation sequencing (NGS) were used to further examine the ROS1 status in cases that were discrepant between FISH and IHC, based on staining in the cytoplasm of 2+ or above in more than 30% of total tumor cells considered as IHC positive. Here, we define the consensus status as the most frequent result across the 5 different methods (IHC, FISH, RT-PCR, RNA NGS, and DNA NGS) we used to determine ROS1 status in these cases.


Results.—
Of the IHC scoring methods examined, staining in the cytoplasm of 2+ or above in more than 30% of total tumor cells considered as IHC positive had the highest correlation with a FISH-positive status, reaching a positive percentage agreement of 97.8% and negative percentage agreement of 89.5%. A positive percentage agreement (100%) and negative percentage agreement (92.0%) was reached by comparing ROS1 (SP384) using a cutoff for staining in the cytoplasm of 2+ or above in more than 30% of total tumor cells to the consensus status.


Conclusions.—
Herein, we present a standardized staining protocol for ROS1 (SP384) and data that support the high correlation between ROS1 status and ROS1 (SP384) antibody.
Language
  • English
Open access status
gold
Identifiers
Persistent URL
https://sonar.ch/global/documents/109839
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