| Summary: | BACKGROUND: Diagnostic molecular testing in colorectal cancer (CRC) offers a number of benefits including predicting prognosis, directing targeted therapies and screening for hereditary cancer syndromes. Molecular testing however is expensive, requires specialist facilities and staff and is time consuming, limiting its widespread availability. The Idylla System is an automated testing platform that could overcome these issues. AIMS: To appraise the suitability of the Idylla System for use in clinical practice by evaluating the system’s accuracy and financial impact. HYPOTHESIS: The Idylla System has high accuracy for detecting mutations in BRAF, KRAS and NRAS genes in CRC resection tissue and is a cost-effective alternative to current testing platforms. METHODS: Ethical approval was granted by Oxfordshire Research and Ethics Committee A (reference: 04/Q1604/21). Diagnostic accuracy was determined for the Idylla System in detecting BRAF and KRAS mutations with a comparison against conventional polymerase chain reaction (PCR). Further validations were also performed for BRAF, KRAS and NRAS mutation testing against NGS and IHC methods. An audit of the molecular diagnostics workload was carried out and a cost-analysis performed. RESULTS: The Idylla system had a sensitivity of 100.0% (95% CI: 88.3% to 100.0%) and a specificity of up to 100.0% (95% CI: 94.7% to 100.0%) for detecting BRAF mutations and a sensitivity of 100.0% (95% CI: 79.6% to 100.0%) and a specificity of up to 92.9% (95% CI: 68.5% to 98.7%) for detecting KRAS Mutations. There was 100% concordance for NRAS testing. A cost-analysis estimated that the Idylla System could save from around £12,000 to anywhere up to £40,000 per year in some centres. CONCLUSIONS: The results support the hypothesis that the Idylla System is an accurate system for detecting relevant mutations in CRC and demonstrate the system to be cost-effective. The Idylla system is therefore suitable for use in routine clinical practice.
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