Oncology Publications

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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Performance of Ultra-Rapid Idylla EGFR Mutation Test in Non-Small-Cell Lung Cancer and Its Potential at Clinical Molecular Screening

Suda et al. 2023 - Cancers (Basel) - May 2023

In this study, the accuracy and potential clinical utility of the Idylla^™ EGFR Mutation Test as a molecular screening platform in terms of turnaround time and molecular testing cost has been demonstrated. This in both settings, early stage and advanced NSCLC.

FACILITATE STUDY: A real-world, multicenter, prospective study investigating the utility of a rapid, fully automated real-time PCR assay versus local reference methods for detecting epidermal growth factor receptor variants in NSCLC

Behnke et al. - Pathology & Oncology Research - 2023

“FACILITATE was a real-world, prospective, multicenter European study that evaluated performance and aTAT of the Idylla™ EGFR Mutation Test compared with local reference methods in real-life NSCLC setting. The high level of concordance, 98%, illustrates robustness and accuracy of the Idylla™ EGFR Mutation Test in a real-world setting. In this study, the Idylla™ EGFR Mutation Test reduced overall aTAT of results by a median of 1 week versus local reference methods results. Moreover, per cumulative analysis of samples processed per aTAT, results were available for 90% of samples within 1 week versus approximately 3 weeks using the Idylla™ EGFR Mutation Test versus local reference methods, respectively.”

Improving Time-to-Treatment for Advanced Non-Small Cell Lung Cancer Patients through Faster Single Gene EGFR Testing Using the Idylla EGFR Testing Platform

Banyi et al. - Current Oncology Journal - 2022

Using the Idylla^TM EGFR test as part of the molecular testing repertoire in advanced-stage NSCLC patients could significantly reduce Time To Treatment.

Clinical performance evaluation of the Idylla EGFR Mutation Test on formalin-fixed paraffin-embedded tissue of non-small cell lung cancer

Delgado-Garcia et al. - BMC Cancer. - April 2020

A retrospective study to compare the performance of the Idylla™ EGFR Mutation Test with the Therascreen® EGFR RGQ PCR v2, Qiagen by selecting 132 archived FFPE NSCLC samples. An Overall Percent Agreement (OPA) between the two methods of 95.38% was observed, with a PPA of 93.2% and NPA of 97.2%. The failure rate on Therascreen® (23%) was substantially higher than on Idylla™ (7%).

Targeted Assessment of the EGFR Status as Reflex Testing in Treatment-Naive Non-Squamous Cell Lung Carcinoma Patients: A Single Laboratory Experience (LPCE, Nice, France)

Lassalle et al. - Cancers. - April 2020

A prospective, observational, single-center study to evaluate if an EGFR-specific PCR assay still has a place in the daily practice of an academic hospital center. The authors describe the implementation of a new laboratory workflow where the actionable biomarkers EGFR (Idylla™), ALK (IHC), ROS1 (IHC), BRAF (IHC) and PD-L1 (IHC) have been tested rapidly for NSCLC stage IIIB/IV samples at baseline (n=900).

Comparison of Biocartis IDYLLA ™ cartridge assay with Qiagen GeneReader NGS for detection of targetable mutations in EGFR, KRAS/NRAS, and BRAF genes

Haiduk et al. - Exp Mol Pathol. - March 2021

In this retrospective comparison study, the sensitivity of the Idylla™ EGFR Mutation Test was 94%. It has been demonstrated that in a pandemic situation, when other standard assays for in vitro diagnostics were temporarily unavailable due to the disruption of established delivery chains, the authors were forced to implement alternative testing methods that enabled at least basic therapy decision making. They selected the Idylla™ Platform because of its performance, ease-of-use and rapid turnaround time.