TEST:

Idylla™ EGFR Mutation Test

The mean molecular testing cost per ultra-rapid tested patient, including panel sequencing for cases with negative/failed rapid tests, was $550.53 (standard deviation $284), slightly less than the $571 cost for panel sequencing. Single gene testing of patients with urgent clinical need or high probability of mutation may allow rapid time to treatment at similar testing costs.

Idylla™ MT is a precise and cost-effective alternative for the detection of EGFR mutations, especially in resource-limited settings. Its main limitations include restricted mutation detection and possible false negatives in samples with low tumor DNA. Its complementary use with broader molecular techniques is recommended to optimize the detection and management of NSCLC.

"Biocartis NV...is pleased to announce that its Idylla EGFR Mutation Test has received the European Union (EU) Technical Documentation Assessment and Quality Management System certificate under the European In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR), making it the first Idylla Test to be certified as a Class C Companion Diagnostic (CDx) IVD Medical Device under the IVDR framework....While the IVDR-certified Idylla EGFR Mutation Test is now available to customers across Europe, with availability in other non-US markets expected to follow progressively."

The prevalence of EGFR mutations in early stage (IA-IIIB), resectable, non-squamous NSCLC observed in our study is consistent with that reported in advanced NSCLC in Spain. Molecular testing is crucial in early-stage NSCLC and can be performed either with single-gene testing or NGS.

"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."

Our study highlights that NGS is able to identify a much higher number of actionable EGFR mutations than RT-qPCR approaches, thereby providing many more patients the opportunity to receive targeted EGFR treatments.

The Idyllaâ„¢ system is a rapid and effective method that enables sensitive and reliable detection of EGFR mutations in FFPE samples of NSCLC patients, with minimal molecular expertise or infrastructure.

The Idylla EGFR mutation assay is highly concordant with commercially available NGS tests. It offers several advantages, including reduced TAT, minimal hands-on time, and lower sample input requirements.

"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."

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.

The high EGFR-positivity rate among ultra-stat tested patients indicates effective identification of probable EGFR-positive cases by clinicians, with race being the most significant predictor of EGFR mutation. These findings will support the development of decision aids for selection of EGFR testing modality.

Additionally, three of the patients, who had measurable tumors, showed partial responses to afatinib and osimertinib. The L858R mutation associated with L858R-K860I and L858R-L861F doublet mutations could be detected using Idylla but not cobas EGFR tests. Using next-generation sequencing analysis should be considered after initial negative reports from the cobas test, because patients with L858R doublet mutations may benefit from EGFR-TKIs.