Overview:
As next-generation sequencing becomes a ubiquitous part of routine cancer care, it’s impact in designing and refining drug development remains in flux. Clinical trial design, biomarker identification and cohort analysis have begun to adapt to the changing landscape over the past decade however challenges remain with standardization and federation of data.
In this webinar we will explore the only kitted CGP assay submitted to FDA for PMA up to this point, TruSight Oncology 500 (TSO500) from Illumina. Available as a research-use-only tool, TSO500 sets the standard for reproducibility across sites, with exceptional accuracy and specificity across a broad range of preserved tissue types.
During this webinar we will discuss:
- An overview of comprehensive genomic profiling (CGP)
- Accuracy and variability of distributed kit: TSO500 RUO
- Validation of TSO500 tissue and preliminary data on ctDNA
The application of NGS in oncology clinical trial biomarker studies
Speakers:
Jin Li
Jin has been in the molecular diagnostics and oncology biomarker field for over 20 years. His current role at ICON includes leading ICON’s NGS specialty lab on assay development and clinical trial assay testing.
Prior to working at ICON, he spent 7 years at MolecularMD building and leading NGS testing in oncology biomarker testing in clinical trial (MolecularMD acquired by ICON in 2019). Prior to this, he spent two years at Genzyme Genetics, developing high-complexity genetic tests. Jin’s academic credentials include an MD from Tianjin Medical University and a PhD in Molecular and Cellular Physiology from Tufts University.
After completing his doctorate, he served as a postdoctoral researcher and instructor at the Dana-Farber Cancer Institute at Harvard Medical School, where he made critical contribution to the inventions of a novel real-time PCR method and a mutation enrichment method, COLD-PCR.
Jason Gottwals
Jason has been in the molecular diagnostics field for over 22 years. His current role at Illumina is designed to help large cancer sequencing operations recognize and execute opportunities for success. Prior to Illumina he spent 10 years at PathGroup (PG) designing and executing an oncology program in partnership with Dr. Pranil Chandra, now Chief Genomics Officer at PG.