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This podcast from Q Squared Solutions looks at factors sponsors should consider when preparing for clinical trials.
Standardization of Tumor Mutational Burden by Alignment to Reference Standards
Laboratory Considerations for Clinical Trials
28 minutes 22 seconds
6 years ago
Standardization of Tumor Mutational Burden by Alignment to Reference Standards
In this episode, Victor Weigman, Director of Translational Genomics at Q Squared Solutions and Mark Stewart, Vice President of Science Policy at Friends of Cancer Research (FOCR) joined to talk about standardization of TMB measurements by alignment to reference standards.
TMB differs from other biomarkers such as PDL1 in that:
"...we're leveraging next generation sequencing to generate a composite score from tens of thousands or in some cases millions of bases of sequence. So really you're summarizing this collection of mutations in a singular value versus a more qualitative range of expression levels done by looking at proteins in a microscope. - Victor Weigman
One challenge is that as treatments are being developed, the thresholds for the diagnostics are out of sync. Friends of Cancer Research understands the difficulty of harmonizing assays to a standard after FDA approval. For that reason, there is strong interest in harmonizing the results of different assays to a standard reference set.
Laboratory Considerations for Clinical Trials
This podcast from Q Squared Solutions looks at factors sponsors should consider when preparing for clinical trials.
