11/11/2022 0 Comments Tso500 local app![]() ![]() Only two TSO500 libraries had concentrations less than 3 ng/μL (1.5 and 2.1 ng/μL) for these two samples, twice the volume of the bead-normalized libraries was used in NGS sequencing. Q32851 Thermo Fisher, Waltham, MA) was used to quantify the hybridization capture–enriched NGS libraries before library normalization. The library was prepared manually according to the manufacturer's protocol, with 24 samples per batch. 20028214 Illumina), was used for the TSO500 NGS library preparation. The TruSight Oncology 500 DNA Kit, for use with NextSeq (48 samples) (cat. DNA fragmentation was performed using the Covaris (Woburn, MA) M220 focused-ultrasonicator with a setting of 75 W peak incident power, 25% as duty factor, 1000 cycles per burst, and treatment time of 6 minutes per sample at 4☌. TSO500 was evaluated with 48 to 50 ng of leftover FFPE DNA material except for two samples, in which 35 and 37 ng of DNA were used. Tso500 local app software#As a commercial assay with global kit distribution complete with an off-the-shelf software package, TSO500 may provide additional access to immunotherapy for patients with tumors with TMB ≥10 mutations/Mb. TSO500 TMB was associated significantly with the best overall response, and the selected cut-off had comparable clinical utility with respective cut-offs for the reference methods in predicting response to pembrolizumab. There was high correlation and concordance of TSO500 TMB with both reference methods. Clinical utility of the selected TSO500 cut-off (10 mutations/Mb) was assessed by calculating the sensitivity, specificity, positive and negative predictive values, and objective response rate enrichment. The TSO500 cut-off for TMB-high was selected based on the receiver-operating characteristic curve analysis against each reference method's cut-off for TMB-high. TSO500 TMB was evaluated for correlation and concordance with two reference methods: FoundationOneCDx and whole-exome sequencing. TSO500 is a panel-based next-generation sequencing assay with broad availability, quick turnaround time, and a standardized bioinformatics pipeline. To expand TMB assessment for enriching response to pembrolizumab, TMB measurement from TruSight Oncology 500 (TSO500) was evaluated in archival pan-tumor samples from 294 patients enrolled in eight pembrolizumab monotherapy studies. Pembrolizumab is approved for treating patients with unresectable or metastatic solid tumors with high tumor mutational burden (TMB), as assessed by the Food and Drug Administration–approved companion diagnostic FoundationOneCDx, after progression on prior treatment. ![]()
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