Study assessing NSCLC and melanoma patient samples compares In-House and outsourced testing

A new clinical research study, led by Dr. Paul Hofman, head of the laboratory of clinical and experimental pathology at Pasteur Hospital in Nice, France, has assessed tumour mutation burden status in randomly selected formalin-fixed paraffin-embedded samples from 51 NSCLC and 25 melanoma patients who were previously treated with checkpoint inhibitors. The results showed that TMB assessments carried out in a clinical laboratory using the Oncomine Tumor Mutation Load Assay delivers results and predictive value as accurately as an outsourced next-generation sequencing panel. Correlation scores were high for both NSCLC (R2 = 0.88) and melanoma (R2 = 0.95). Prediction of a durable clinical response by receiver operating characteristic was comparable between Oncomine Tumor Mutation Load Assay (AUC = 0.70) and the outsourced test (AUC = 0.74). Analysis was not possible in 22% of NSCLC and 8% of melanoma cases because of the strict sample requirements of the outsourced test.
Luca Quagliata, global head of medical affairs for clinical NGS and oncology, Thermo Fisher Scientific, said: “Among the problems with outsourcing samples are limited control over data analysis parameters, access to raw data and its ownership, and slow turnaround times. Slow turnaround time becomes even more problematic if the test cannot return results because higher quantities of sample are required or the material is degraded. This study clearly shows that in-house testing, combined with very low sample requirements of Oncomine gene panels, including the Tumor Mutation Load Assay, help overcome these obstacles.”
Dr. Paul Hofman, head of the laboratory of clinical and experimental pathology at Pasteur Hospital in Nice, said: “Results can take up to 20 days or more when a patient’s sample is sent out for TMB analysis. With the Oncomine Tumor Mutation Load Assay, we were able to secure results in as little as seven days. This shortened turnaround time enables faster access to test results and placement for patients into applicable clinical studies.”