Abstract 5632
Background
To predict the response to EGFR tyrosine kinase inhibitor (TKI) therapy in non-small cell lung cancer (NSCLC) patients, formalin-fixed paraffin-embedded (FFPE) tumor tissue is routinely tested for the presence of somatic mutations in the epidermal growth factor receptor (EGFR) gene. Sufficient tumor tissue is not always available and ctEGFR testing from plasma is an alternative approach for the detection of EGFR mutations. Therefore, a fast and fully automated ctEGFR assay with minimal hands-on time should allow laboratories to quickly generate EGFR testing results.
Methods
IdyllaTM (Biocartis) is a fully integrated molecular diagnostics platform that combines speed and ease of use with high sensitivity and high multiplexing capabilities. In terms of ctDNA testing, it overcomes the time-consuming step of ctDNA extraction from plasma. After insertion of 2 ml of plasma into the cartridge, the complete process of ctDNA extraction, real-time PCR, data analysis and reporting is fully automated. The ctEGFR prototype assay allows the detection of 49 mutations including insertions and deletions in exons 18, 19, 20 and 21. The results obtained by the ctEGFR prototype assay were compared with NGS (sensitivity 2-5%).
Results
Sixty-four NSCLC samples were tested with both assays. Overall, 34 mutations were detected by NGS and confirmed by the ctEGFR prototype assay. In 33 samples, NGS detected no mutation. The ctEGFR prototype assay detected 7 additional mutations in this cohort. Retesting with the cobas EGFR Mutation Test v2 confirmed the presence of these mutations. Analytical sensitivity was assessed for 20 mutations using plasma spiked with synthetic targets. Analytical sensitivities ranging from 1 to 4% were obtained for the tested mutations. Inclusivity was demonstrated for 49 mutations in total. The average turnaround time of a run was <2h 40 min and the hands-on time for the assay was <2 min.
Conclusions
This study shows that the Idylla™ platform enables the development of a prototype ctEGFR assay with high sensitivity and ease of use combined with a fast turnaround time for the testing of 49 relevant EGFR mutations in 2 ml of plasma from NSCLC patients.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Biocartis.
Funding
Biocartis.
Disclosure
M. Reijans: Full / Part-time employment: Biocartis. S.V. Gestel: Full / Part-time employment: Biocartis. E.D. Haes: Full / Part-time employment: Biocartis. C. Vandesteene: Full / Part-time employment: Biocartis. J.M. Castro Gomez: Full / Part-time employment: Biocartis. C. Gouedard: Full / Part-time employment: BioPath Innovations SA. S. Patera: Full / Part-time employment: BioPath Innovations SA. S. Murray: Full / Part-time employment: BioMarker Solutions Ltd. G.G. Maertens: Full / Part-time employment: Biocartis.
Resources from the same session
4096 - Patient experience and use of an intervention combining nurse-led telephone and technologies for the monitoring of oral cancer medication
Presenter: Marie Ferrua
Session: Poster Display session 3
Resources:
Abstract
6042 - Harnessing nurse leadership to implement a project for electronic scheduling of chemotherapy
Presenter: Emma Masters
Session: Poster Display session 3
Resources:
Abstract
3123 - Turkish Cancer Patients’ Preference for Information and Communication Technologies
Presenter: Esra ildes
Session: Poster Display session 3
Resources:
Abstract
6062 - Unmet Needs in Oncology Research related to radiological response evaluation: a multi-center survey in three European countries
Presenter: Sophie Nisse Durgeat
Session: Poster Display session 3
Resources:
Abstract
6109 - A program implementation to facilitate intraoperative brachytherapy between hospitals
Presenter: Marc Garcia Casellas
Session: Poster Display session 3
Resources:
Abstract
1772 - Using Mobile-Based Health Care Applications Outcomes: Mini Systematic Review
Presenter: Aydanur Aydin
Session: Poster Display session 3
Resources:
Abstract
2792 - Evaluation of an education program for cancer patients receiving chemotherapy
Presenter: Iraqi Amina
Session: Poster Display session 3
Resources:
Abstract
3715 - iGestSaúde: Application for self-management of symptoms during chemotherapy treatment
Presenter: Bruno Magalhaes
Session: Poster Display session 3
Resources:
Abstract
3854 - Palliative care requirements of cancer patients and investigation of knowledge and expectations related to palliative care of the patients and their families
Presenter: Ozlem Topkaya
Session: Poster Display session 3
Resources:
Abstract
4997 - Hospice care, what to expect? An exploration of the expectation of future hospice patients
Presenter: Merel van Klinken
Session: Poster Display session 3
Resources:
Abstract