Aims The aim of this quality improvement project was to improve the turnaround time of B-raf proto-oncogene (BRAF) mutation testing in patients with malignant melanoma to support oncologists in making timely treatment decisions.
Methods This is a prospective in-house verification of the Idylla BRAF test as compared with DNA panel next-generation sequencing (NGS) performed at an external laboratory.
Results The Idylla BRAF test had an overall concordance of 95% compared with NGS. This was considered sufficiently good for use in patients with a poor performance status who were at risk of rapid clinical deterioration. Reliable results can be generated using the Idylla BRAF test in tissue sections with tumour neoplastic cell content below 50%. We present a multidisciplinary clinical care algorithm to support dual testing.
Conclusions The Idylla BRAF test has the potential to make a significant positive impact on progression-free survival of malignant melanoma patients due to its rapid turnaround time. The Idylla BRAF test can be used as an adjunct to NGS for timely management of patients, particularly those with a poor performance status at presentation.
- Diagnostic Techniques and Procedures
- Genes, Neoplasm
- Medical Oncology
- Pathology, Molecular
Data availability statement
Data are available on reasonable request.
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Handling editor Runjan Chetty.
Contributors AF conceived the project, wrote the study protocol for peer review by JSRC and secured testing apparatus. AF wrote the manuscript, performed part of the data analysis and is guarantor of the work. KM performed part of the data analysis, contributed to the manuscript and performed the Idylla testing. RDF provided clinical oncological context and contributed to the manuscript writing.
Funding This is an investigator initiated study for service development purposes particular to Swansea Bay University Health Board. It was supported by Biocartis by provision of Idylla BRAF Mutation test cartridges. Biocartis did not seek to influence the purpose or design of this project nor did they have any involvement in the manuscript preparation.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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