PMID- 28763012
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200930
IS  - 2072-6694 (Print)
IS  - 2072-6694 (Electronic)
IS  - 2072-6694 (Linking)
VI  - 9
IP  - 8
DP  - 2017 Aug 1
TI  - Performance of a RT-PCR Assay in Comparison to FISH and Immunohistochemistry for 
      the Detection of ALK in Non-Small Cell Lung Cancer.
LID - 10.3390/cancers9080099 [doi]
LID - 99
AB  - Patients with lung cancers harboring an activating anaplastic lymphoma kinase 
      (ALK) rearrangement respond favorably to ALK inhibitor therapy. Fluorescence in 
      situ hybridization (FISH) and immunohistochemistry (IHC) are validated and widely 
      used screening tests for ALK rearrangements but both methods have limitations. 
      The ALK RGQ RT-PCR Kit (RT-PCR) is a single tube quantitative real-time PCR assay 
      for high throughput and automated interpretation of ALK expression. In this 
      study, we performed a direct comparison of formalin-fixed paraffin-embedded 
      (FFPE) lung cancer specimens using all three ALK detection methods. The RT-PCR 
      test (diagnostic cut-off DeltaC(t) of </=8) was shown to be highly sensitive (100%) 
      when compared to FISH and IHC. Sequencing of RNA detected full-length ALK 
      transcripts or EML4-ALK and KIF5B-ALK fusion variants in discordant cases in 
      which ALK expression was detected by the ALK RT-PCR test but negative by FISH and 
      IHC. The overall specificity of the RT-PCR test for the detection of ALK in cases 
      without full-length ALK expression was 94% in comparison to FISH and sequencing. 
      These data support the ALK RT-PCR test as a highly efficient and reliable 
      diagnostic screening approach to identify patients with non-small cell lung 
      cancer whose tumors are driven by oncogenic ALK.
FAU - Hout, David R
AU  - Hout DR
AD  - Insight Genetics, Inc., Suite 510, 2 International Plaza, Nashville, TN 37217, 
      USA. dhout@insightgenetics.com.
FAU - Schweitzer, Brock L
AU  - Schweitzer BL
AD  - Insight Genetics, Inc., Suite 510, 2 International Plaza, Nashville, TN 37217, 
      USA. bschweitzer@insightgenetics.com.
FAU - Lawrence, Kasey
AU  - Lawrence K
AD  - Insight Genetics, Inc., Suite 510, 2 International Plaza, Nashville, TN 37217, 
      USA. klawrence@insightgenetics.com.
FAU - Morris, Stephan W
AU  - Morris SW
AD  - Insight Genetics, Inc., Suite 510, 2 International Plaza, Nashville, TN 37217, 
      USA. smorris@insightgenetics.com.
FAU - Tucker, Tracy
AU  - Tucker T
AD  - Department of Pathology and Laboratory Medicine, BC Cancer Agency, 675 West 10th 
      Avenue, Vancouver, BC V5Z 1L3, Canada. ttucker2@bccancer.bc.ca.
FAU - Mazzola, Rosetta
AU  - Mazzola R
AD  - Department of Medical Oncology, British Columbia Cancer Agency, VIC 2410 Lee 
      Avenue, Victoria, BC V8R 6V5, Canada. rosetta.mazzola@alumni.ubc.ca.
FAU - Skelton, Rachel
AU  - Skelton R
AD  - Insight Genetics, Inc., Suite 510, 2 International Plaza, Nashville, TN 37217, 
      USA. rachelleahskelton@gmail.com.
FAU - McMahon, Frank
AU  - McMahon F
AD  - Insight Genetics, Inc., Suite 510, 2 International Plaza, Nashville, TN 37217, 
      USA. fmcmahon@insightgenetics.com.
FAU - Handshoe, John
AU  - Handshoe J
AD  - Insight Genetics, Inc., Suite 510, 2 International Plaza, Nashville, TN 37217, 
      USA. jhandshoe@insightgenetics.com.
FAU - Lesperance, Mary
AU  - Lesperance M
AD  - Department of Mathematics and Statistics, University of Victoria, Box 1700, STN 
      CSC, Victoria, BC V8W 2Y2, Canada. mlespera@uvic.ca.
FAU - Karsan, Aly
AU  - Karsan A
AD  - Department of Pathology and Laboratory Medicine, BC Cancer Agency, 675 West 10th 
      Avenue, Vancouver, BC V5Z 1L3, Canada. akarsan@bccancer.bc.ca.
FAU - Saltman, David L
AU  - Saltman DL
AD  - Department of Medical Oncology, British Columbia Cancer Agency, VIC 2410 Lee 
      Avenue, Victoria, BC V8R 6V5, Canada. david.saltman@bccancer.bc.ca.
LA  - eng
GR  - HHSN261201200047C/CA/NCI NIH HHS/United States
PT  - Journal Article
DEP - 20170801
PL  - Switzerland
TA  - Cancers (Basel)
JT  - Cancers
JID - 101526829
PMC - PMC5575602
OTO - NOTNLM
OT  - anaplastic lymphoma kinase
OT  - fluorescence in situ hybridization
OT  - immunohistochemistry
OT  - non-small cell lung cancer
OT  - reverse transcriptase-polymerase chain reaction
COIS- Kasey Lawrence, John Handshoe, David R. Hout, Frank McMahon, Stephan W. Morris, 
      Brock L. Schweitzer and Rachel Skelton are employees and/or equity owners of 
      Insight Genetics, the molecular diagnostics firm that together with QIAGEN 
      developed and markets the ALK RGQ RT-PCR Kit. The other authors declare no 
      conflict of interest.
EDAT- 2017/08/02 06:00
MHDA- 2017/08/02 06:01
PMCR- 2017/08/01
CRDT- 2017/08/02 06:00
PHST- 2017/06/15 00:00 [received]
PHST- 2017/07/19 00:00 [revised]
PHST- 2017/07/29 00:00 [accepted]
PHST- 2017/08/02 06:00 [entrez]
PHST- 2017/08/02 06:00 [pubmed]
PHST- 2017/08/02 06:01 [medline]
PHST- 2017/08/01 00:00 [pmc-release]
AID - cancers9080099 [pii]
AID - cancers-09-00099 [pii]
AID - 10.3390/cancers9080099 [doi]
PST - epublish
SO  - Cancers (Basel). 2017 Aug 1;9(8):99. doi: 10.3390/cancers9080099.