GenomOncology has developed a set of tools, the GO Validation
Toolkit, to dramatically reduce the effort and complexity required by
pathology and medical genetics laboratories to validate NGS tests.
GenomOncology’s Services Team is available to provide as much
support as you need, whether it’s selecting the right samples to run,
troubleshooting your assay performance, or statistical evaluation. We
have worked with many labs, experienced and new to NGS, to simplify
their efforts, speed up their processes, and deliver confident results.
The GO Validation Toolkit offers a simple and robust workflow to
streamline the validation process...
STEP 1 - PLANNING
Plan an efficient validation, considering factors such as budget,
time, desired sensitivity, etc. Determine the right number of runs
and the most appropriate samples to test.
- Requirements gathering workbook
- Week by week scheduling of sequencing / analysis
- Detailed cost projections
- Power calculations for determining sample needs and run counts
- Flexible use of cell lines, synthetic, plasmid DNAs, along with retrospective clinical samples with known variants
STEP 2 - ANALYSIS
Simplified, highly automated data analysis of your run results.
Determine analytical performance.
- Results broken down by variant type, such as single nucleotide variants, insertions, deletions, translocations and other structural variants, considering factors such as GC content and INDEL size
- Document repeatability and reproducibility
- Statistical evaluation performed leveraging GO KMS and python data science tools
- Transparent, documented statistical algorithms consistent with professional organization and regulatory agency guidelines
STEP 3 - IMPLEMENTATION
Create validation reports suitable for regulatory review. Transfer
analysis parameters into the production environment.
- Final results delivered in an easy-to- understand PDF document with a table of contents, chapters based on the variant types, along with a glossary of words and meaning, and a summary evaluation ready for compliance or QC audits
- Results can also be exported as Excel workbooks based on customizable templates
- Determine the optimal production settings to maximize accuracy and quality control
- The combination of program management, analysis and reporting features makes the GO Validation Toolkit an ideal platform to manage assay validation.