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 the process, 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 analytic 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 in the R statistical computing language
  • 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 Word 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, uploadable to the GO Clinical Workbench

The combination of program management, analysis and reporting features makes the GO Validation Toolkit an ideal platform to manage assay validation.