TEST:

Idylla™ GeneFusion Assay

"Seven abstracts from leading research and academic institutions will be presented as posters, highlighting the rapid, fully automated molecular testing capabilities of the Idylla Platform across several different cancer types, including lung cancer, thyroid cancer, endometrial carcinoma and colorectal cancer. Biocartis also continues to focus on melanoma, blood, brain and breast cancer."

Screening for ALK rearrangements with IHC is both reliable and cost effective. In-house testing with IHC removes reliance on send-out testing for ALK detection, effectively cutting costs and decreasing TAT. Additionally, the creation of a reflex algorithm can improve lung cancer biomarker testing processes within hospitals.

Our standard operating procedure (SOP) was updated to perform orthogonal confirmation testing for stand-alone equivocal NTRK1/2 and equivocal NTRK3 (5' failure), but to ignore equivocal NTRK3 (5' intact) and report as NTRK2/3 indeterminate. Re-verification showed no change to ALK, ROS1, RET, MET ex14, and NTRK1 results. Sensitivity of NTRK2 detection was significantly increased (80% after orthogonal testing).

"Biocartis NV...is pleased to announce that six abstracts highlighting the benefits of Idylla will be presented at the Association for Molecular Pathology (AMP) Annual Meeting, taking place November 19th to November 23rd, 2024 in Vancouver, Canada. In addition, Biocartis will host a free corporate workshop. Six Idylla abstracts from renowned institutions will be presented at this year's AMP conference, showcasing the strong collaborations Biocartis has built with leading research and academic partners."

She will highlight the integration of cytology and small biopsy specimens, particularly in lung and thyroid cancers, within a large cancer center. Highlights: • Evaluation of Idylla™ for rapid on-site assessment and archival aspirate smear and FFPE cell block testing • Comparison with large panel NGS assays • Data of interest to cytology labs • Review of NTRK case studies within the research of Idylla™ GeneFusion This workshop will provide insights for pathologists seeking to enhance workflows and embrace cutting-edge cytopathology techniques.

Our data confirm that MPE are suitable material for investigating fusion alterations. The Idyllaâ„¢ GeneFusion, although indicated for investigation of tissue samples, offers the possibility of performing a molecular characterization of supernatants without undertaking the entire cfRNA extraction procedure providing a rapid and reliable strategy for the detection of actionable genetic alterations.

However, NGS had a 12-day longer TAT compared to EGFR PCR. Gene fusion-panel PCR and NGS identified an additional 11.6% of patients harboring actionable alterations who may benefit from FDA-approved targeted therapies.

Given its short turnaround time of about 3 h, it is a time-efficient upfront screening tool in FFPE samples, supporting rapid clinical decision making. Moreover, expression-imbalance-based detection of potentially novel fusions may be easily verified with other routine technologies without delaying treatment initiation.

"Biocartis Group NV...announces that four study abstracts on Idylla™ have been selected for poster presentations at the international ESMO (European Society of Molecular Oncology) congress, taking place between 20-24 October 2023 in Madrid (Spain). The studies show excellent data for the Idylla™ GeneFusion Assay and Idylla™ EGFR Mutation Assay....The first study prospectively tested lung cancer samples on the Idylla™ Platform as part of routine2 lung profiling locally and from over 60 UK hospitals....The second abstract presents the results of a multicenter study that was conducted in a routine clinical2 setting involving 12 clinical centers across Europe....The third abstract presents the results of the ORIGEN study, a multicenter study on the prevalence of EGFR gene mutations in patients with early-stage resectable non-small cell lung cancer in Spain (in collaboration with AstraZeneca Spain)."

We also demonstrate the need for additional reflex testing capability on larger DNA and fusion panels for a small subset of lung cancers bearing rare single-nucleotide variants, indels and fusion transcripts and secondary, post-treatment resistance mutations. A similar testing workflow could be adopted for other solid tumor types for which extensive gene/fusion variant profiles are available both in the treatment-naïve and post-therapy settings.

Clinical testing laboratories may benefit from improved understanding of strengths and limitations of different workflows. It is important to keep these in mind when reporting results.