TEST:

Idylla™ KRAS Mutation Test

The Idylla KRAS Mutation Test can be reliably applied to FNA needle rinses in both saline and Cytolyt, yielding robust results in samples with high tumor content. Nevertheless, careful review of amplification curve patterns is essential in this setting.

P2, N=27, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Oct 2025 --> Oct 2027 | Trial primary completion date: Oct 2025 --> Oct 2027

The scalability of Bridge Capture was validated using an expanded panel and synthetic DNA targets, showing a strong linear correlation between observed and expected VAF values. This study demonstrates the scalability and accuracy of the Bridge Capture platform, and its potential to enhance mutation detection and clinical decision-making using ctDNA samples from patients with mCRC.

"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."

It is feasible to yield actionable molecular testing results from cytology specimens within 2 to 3 hours of the patient's diagnostic procedure, and aspirate smears can be triaged for this use at the time of the rapid on-site evaluation. Targetable genetic alterations can be detected from destained cytology aspirate smear slides and unstained FFPE cell blocks with high accuracy, precision, and analytical sensitivity and specificity. The cost of each cartridge ranges from $127 to $462 and is covered by the average national reimbursement schemes.

Detection of KRAS mutations, particularly the G12 C subtype, may be significant for patients with CRC and has possible therapeutic implications. However, rare KRAS concomitant mutations in CRC patients suggest that each individual may present distinct therapeutic responses. KRAS testing alongside the identification of other affected genes in the same patient will make the treatments even more personalized by contributing more accurately to the clinical decision process. Overall, early diagnosis using novel molecular techniques may improve the management of CRC by providing the most efficient therapies for Moroccan patients.

"Biocartis...announced an expansion of its collaboration with Merck Serono Middle East and Merck Saudi Ltd...The collaboration aims to improve patient access to RAS biomarker testing in the Middle East and North Africa (MEA) region."

KRAS mutation testing on liquid-based cytology using the Idylla or equivalent technique, combined with the PDAC EUS-FNB sample, should become a standard for diagnosis to avoid delaying treatment by doing another biopsy. Furthermore, knowledge of the KRAS status from treatment initiation could be used to isolate mutations requiring targeted treatments or inclusion in clinical research trials, especially for wild-type KRAS PDAC.

"Biocartis...announces that it will host a free corporate workshop at the Annual Meeting of the ‘Association for Molecular Pathology’ (AMP), a leading molecular diagnostics conference, taking place between 14-18 November 2023 in Salt Lake City, Utah (US)."

The Idylla Rapid IDH1/2 Mutation Assay had 92% concordance with NGS for FFPE sections. Compared with Idylla EGFR and KRAS assays (previously published) both control and target Cqs were considerably higher using the same number of sections or amount of DNA. A large DNA input requires stewardship for effective tissue utilization for molecular testing, especially in glioma biopsy samples, which may be limited.

P2, N=27, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Oct 2023 --> Oct 2025 | Trial primary completion date: Oct 2023 --> Oct 2025

We report the largest North African analysis of NRAS and KRAS status in colorectal metastatic patients. This study showed the ability in low middle income countries to perform a high rate of valid tests and the unusual trend towards older patients for NRAS mutations.