PMID- 23499337
OWN - NLM
STAT- MEDLINE
DCOM- 20131204
LR  - 20181202
IS  - 1943-7811 (Electronic)
IS  - 1525-1578 (Linking)
VI  - 15
IP  - 3
DP  - 2013 May
TI  - ALK status testing in non-small cell lung carcinoma: correlation between 
      ultrasensitive IHC and FISH.
PG  - 341-6
LID - S1525-1578(13)00040-8 [pii]
LID - 10.1016/j.jmoldx.2013.01.004 [doi]
AB  - ALK gene rearrangements in advanced non-small cell lung carcinomas (NSCLC) are an 
      indication for targeted therapy with crizotinib. Fluorescence in situ 
      hybridization (FISH) using a recently approved companion in vitro diagnostic 
      class FISH system commonly assesses ALK status. More accessible IHC is challenged 
      by low expression of ALK-fusion transcripts in NSCLC. We compared ultrasensitive 
      automated IHC with FISH for detecting ALK status on 318 FFPE and 40 matched 
      ThinPrep specimens from 296 patients with advanced NSCLC. IHC was concordant with 
      FFPE-FISH on 229 of 231 dual-informative samples (31 positive and 198 negative) 
      and with ThinPrep-FISH on 34 of 34 samples (5 positive and 29 negative). Two 
      cases with negative IHC and borderline-positive FFPE-FISH (15% and 18%, 
      respectively) were reclassified as concordant based on negative matched 
      ThinPrep-FISH and clinical data consistent with ALK-negative status. Overall, 
      after including ThinPrep-FISH and amending the false-positive FFPE-FISH results, 
      IHC demonstrated 100% sensitivity and specificity (95% CI, 0.86 to 1.00 and 0.97 
      to 1.00, respectively) for ALK detection on 249 dual-informative NSCLC samples. 
      IHC was informative on significantly more samples than FFPE-FISH, revealing 
      additional ALK-positive cases. The high concordance with FISH warrants IHC's 
      routine use as the initial component of an algorithmic approach to clinical ALK 
      testing in NSCLC, followed by reflex FISH confirmation of IHC-positive cases.
CI  - Copyright (c) 2013 American Society for Investigative Pathology and the Association 
      for Molecular Pathology. Published by Elsevier Inc. All rights reserved.
FAU - Minca, Eugen C
AU  - Minca EC
AD  - Departments of Molecular and Anatomic Pathology, Pathology and Laboratory 
      Medicine Institute, Cleveland, OH, USA.
FAU - Portier, Bryce P
AU  - Portier BP
FAU - Wang, Zhen
AU  - Wang Z
FAU - Lanigan, Christopher
AU  - Lanigan C
FAU - Farver, Carol F
AU  - Farver CF
FAU - Feng, Yan
AU  - Feng Y
FAU - Ma, Patrick C
AU  - Ma PC
FAU - Arrossi, Valeria A
AU  - Arrossi VA
FAU - Pennell, Nathan A
AU  - Pennell NA
FAU - Tubbs, Raymond R
AU  - Tubbs RR
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20130313
PL  - United States
TA  - J Mol Diagn
JT  - The Journal of molecular diagnostics : JMD
JID - 100893612
RN  - 0 (Pyrazoles)
RN  - 0 (Pyridines)
RN  - 53AH36668S (Crizotinib)
RN  - EC 2.7.10.1 (ALK protein, human)
RN  - EC 2.7.10.1 (Anaplastic Lymphoma Kinase)
RN  - EC 2.7.10.1 (Receptor Protein-Tyrosine Kinases)
SB  - IM
MH  - Algorithms
MH  - Anaplastic Lymphoma Kinase
MH  - Carcinoma, Non-Small-Cell Lung/*diagnosis/genetics
MH  - Crizotinib
MH  - Gene Rearrangement
MH  - Humans
MH  - Immunohistochemistry/*methods
MH  - In Situ Hybridization, Fluorescence/*methods
MH  - Lung Neoplasms/*diagnosis/genetics
MH  - Pyrazoles/therapeutic use
MH  - Pyridines/therapeutic use
MH  - Receptor Protein-Tyrosine Kinases/*genetics
MH  - Sensitivity and Specificity
MH  - Specimen Handling
EDAT- 2013/03/19 06:00
MHDA- 2013/12/16 06:00
CRDT- 2013/03/19 06:00
PHST- 2012/10/23 00:00 [received]
PHST- 2013/01/11 00:00 [revised]
PHST- 2013/01/28 00:00 [accepted]
PHST- 2013/03/19 06:00 [entrez]
PHST- 2013/03/19 06:00 [pubmed]
PHST- 2013/12/16 06:00 [medline]
AID - S1525-1578(13)00040-8 [pii]
AID - 10.1016/j.jmoldx.2013.01.004 [doi]
PST - ppublish
SO  - J Mol Diagn. 2013 May;15(3):341-6. doi: 10.1016/j.jmoldx.2013.01.004. Epub 2013 
      Mar 13.