1307P - The Biocartis Idylla GeneFusion Assay (RUO) for lung cancer testing: The experience of testing over 5000 tumours in routine practice

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 Idylla^TM 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 Idylla^TM 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 Idylla^TM Cartridge; run time 180 mins; interpretation is via automated analysis using pre-defined cut offs within the Idylla^TM 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 Idylla^TM 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

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 Idylla^TM 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.