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

Huang, Richard S. P.; Smith, Derek; Le, Catherine H.; Liu, Wen-Wei; Ordinario, Ellen; Manohar, Chitra; Lee, Michael; Rajamani, Jaya; Truong, Huan; Li, Jing; Choi, Cindy; Li, Jingchuan; Pati, Amrita; Bubendorf, Lukas; Buettner, Reinhard; Kerr, Keith M.; Lopez-Rios, Fernando; Marchetti, Antonio; Marondel, Ivonne; Nicholson, Andrew G.; Öz, Ayşim Büge; Pauwels, Patrick; Penault-Llorca, Frederique; Rossi, Giulio; Thunnissen, Erik; Newell, Amy Hanlon; Pate, Greg; Menzl, Ina

doi:10.5858/arpa.2019-0085-oa

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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

2019-9-11

Published in:

Archives of Pathology & Laboratory Medicine. - Archives of Pathology and Laboratory Medicine. - 2019, vol. 144, no. 6, p. 735-741

Pathology and Forensic Medicine

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