Articles

Explore a selection of recent articles our company and collaborators have generated. We will continue to be active contributors to the scientific community, further advancing the delivery of precision medicine and improved patient outcomes.

The opinions and conclusions expressed in the following publications are those of the individual authors and do not necessarily reflect the views and opinions of Biocartis and/or its employees.

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Oncology Tests Publications

The usefulness of a novel fully automated PCR-based Idylla test for detection of the BRAF V600E mutation in thyroid tissue: comparison with PNA-clamping PCR, real-time PCR and pyrosequencing

Yeo et al. - J Clin Pathol. - March 2017

A feasibility study showing that the Idylla^TM BRAF Mutation Cartridge can detect the BRAF V600E mutation with high sensitivity in FFPE resected thyroid cancer tissue.

Evaluation, Validation, and Implementation of the Idylla System as Rapid Molecular Testing for Precision Medicine

Huang et al. - J Mol Diagn. - September 2019

The authors describe our evaluation, validation, and implementation of this system for routine testing of BRAF, EGFR, KRAS, and NRAS using formalin-fixed, paraffin-embedded cancer samples. All four Idylla test systems showed excellent concordance with reference methods. The analytical sensitivity ranged from 94.66% to 100%, depending on the cartridge, and specificity was 100%. The turnaround time was shortened by 7 days on average. Idylla testing of a cohort of 25 non-small-cell lung cancer samples with insufficient material for next-generation sequencing testing delivered results for all cases and identified actionable results for eight cases. In addition, patient care would have been changed in four of these cases: targeted therapies were identified in two cases, and repeated biopsies would have been avoided in two cases.

Rapid BRAF Mutation Testing in Pigmented Melanomas

Petty et al. - Am J Dermatopathol. - December 2019

A retrospective study demonstrating that the Idylla™ BRAF Mutation Assay can deal with highly pigmented melanoma samples.

Comparison of BRAF Mutation Screening Strategies in a Large Real-Life Series of Advanced Melanoma Patients.

Colombino et al. - J Clin Med. - August 2020

This study evidenced that Idylla™ was able to detect 16.2% and 4.8% additional BRAF mutations, after Sanger- and pyrosequencing, respectively. Therefore, they argue for a preferential utilization of Idylla™ in clinical practice to eradicate false-negative cases and improve the accuracy of BRAF detection.

Pancreatic cyst fluid harboring a KRAS mutation

Al-Turkmani et al. - Cold Spring Harb Mol Case Stud. - April 2019

Proof-of-concept study using the Idylla™ ctKRAS Mutation Assay for rapid mutation analysis of KRAS in pancreatic cyst fluid. The case study describes the successful analysis of KRAS mutations using pancreatic cyst fluid inserted directly into the Idylla™ ctKRAS cartridge prior to pancreatectomy. Later NGS testing on the resected tissue confirmed the presence of a KRAS G12D mutation.

Rapid EGFR Mutation Testing in Lung Cancer Tissue Samples Using a Fully Automated System and Single-use Cartridge.

Al-Turkmani - Pract Lab Med. - March 2020