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G. Huang
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P3.02 - Biology/Pathology (ID 620)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Biology/Pathology
- Presentations: 1
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.02-019 - Clinical Validation of a Real Time PCR Assay for the Detection of ROS1 Fusion in Chinese Non-Small Cell Lung Cancer (ID 10410)
09:30 - 09:30 | Author(s): G. Huang
- Abstract
Background:
ROS1 fusion has been approved to be the second effective target of Crizontinib in the treatment of non-small cell lung cancer (NSCLC). The traditional way of gene fusion detection is split FISH which is time consuming. A simple and fast real time PCR method (AmoyDx RT-PCR) has been developed for the detection of ROS1 fusion.
Method:
AmoyDx RT-PCR method was developed for detection of 14 types of ROS1 fusions (ADx-ROS1 kit) by combining reverse transcription and real-time PCR. An EGFR-ALK-ROS1 three gene aberration one-shot detection kit (ADx-EAR kit) was developed as well by combing DNA-based mutation detection (for EGFR gene) and mRNA-based fusion detection (for ROS1 and ALK genes). Two cohorts of FFPE NSCLC tissue samples, 1007 and 1137, were analyzed for ROS1 fusions by ADx-ROS1 and ADx-EAR, respectively. For positive samples, Sanger sequencing was used to confirm the fusions.
Result:
In the first cohort of 1007 tumors, 40 (3.97%) were detected to be ROS1 fusion positive and all of the fusions were confirmed by Sanger sequencing to be true fusion positive. In the second cohort of 1137 tumors, 29 (2.55%) were detected to be ROS1 fusion positive that were also confirmed to be true positive by Sanger sequencing. The positivity of ROS1 fusion was detected to be more in adenocarcinoma, female and never-smoker, although no statistical significance was find. Also, ROS1 was detected more in tumors without EGFR mutation and ALK fusion.
Conclusion:
RT-PCR based method is reliable for the detection of ROS1 fusion in FFPE samples of Chinese NSCLC.