Abstract 1307P
Background
Lung non-small cell carcinoma molecular profiling is challenging due to the number of alterations to assess, the small size of the samples and the quick turnaround required in order to offer patients the optimal treatment. We implemented the Biocartis IdyllaTM GeneFusion Assay (RUO) two years ago for ALK, ROS1, RET and MET exon 14 testing. The assay is designed to specifically target 17 fusions variants in ALK, 13 in ROS1 and 7 in RET gene. This provides specific detection of 93% of ALK, 98% of ROS1 and 85% of RET fusion events as reported on COSMIC. We report on our experience on over 5000 cases tested over 2 years.
Methods
We prospectively tested lung cancer samples on the IdyllaTM Platform as part of routine lung profiling locally and from over 60 UK hospitals. Tissue requirements were 1 - 3 x 5 μm sections; tumour burden was assessed on an HE stain prior to running the assay to ensure minimum 10% tumour content. Sections are loaded into the IdyllaTM Cartridge; run time 180 mins; interpretation is via automated analysis using pre-defined cut offs within the IdyllaTM software. Fusions (ALK, ROS1, RET) and MET ex 14 rearrangement are called with corresponding Cq values alongside internal DNA and RNA controls. Manual interrogation of the amplification curves is possible through the IdyllaTM Explore software, if required.
Results
We have tested over 5000 tumours so far.
Table: 1307P
Rate of positivity (ROP) and rate of failure (ROF) for GeneFusion assay
TEST | DETECTED | NOT DETECTED | INVALID | TOTALS | ROP (%) | ROF (%) |
ALK Specific | 66 | 4803 | 410 | 5394 | 1.3 | 7.6 |
ROS Specific | 18 | 4845 | 5394 | 0.4 | ||
RET Specific | 24 | 4843 | 5394 | 0.5 | ||
GEN - MET exon 14 | 106 | 4759 | 5394 | 2.1 |
Conclusions
Our data shows a level of detection of ALK, ROS1, RET, MET exon14 as expected from published data. We had almost 100% of concordance with ALK and ROS1 immunostaining. Test failure was due to either poor quality of RNA or insufficient material to pass QC metrics. More importantly, the assay allows testing to be successfully completed in samples unsuitable for NGS due to low tumour burden. In conclusion, the IdyllaTM GeneFusion Assay offers a rapid, sensitive and specific method for lung sample profiling in routine practice.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
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