Solutions for molecular pathologists that address the full range of requirements for precision medicine and molecular genetics including...
Test validation and production support
The GO Validation Toolkit dramatically reduces the effort required 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...
Plan an efficient validation, considering factors such as budget, time, desired sensitivity, etc. and 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
Simplified, highly automated data analysis of your run results and 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
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.
The GO Clinical Pathology Workbench
Pathology workbench workflow that leads to an actionable report, with full traceability and oversight
The GO Clinical Pathology Workbench is...
- Installed behind the institution’s firewall
- Designed to integrate with current and future information systems (LIS, EMR, etc.)
- Highly configurable (analysis pipeline, report templates and workflow)
- Developed in a high assurance manner to enable the laboratory to comply with applicable laws and regulations.
- Suitable for cancer (solid tumor and heme)
- Supports multiple test modes (NGS, CNV, Gene Fusions, Cytogenetics, IHC, etc.)
- Scalable from targeted panels to whole exome/genome analysis
An overview of the process is described below:
The platform recommends a pass/fail based on run and sample level QC metrics as defined by your assay validation, with trends and audit trails.
- Module mapped directly to sequencer to streamline data input
- Each run and each of its samples measured against thresholds set based on your assay validation
- Track trends of each QC measure to help comply with CAP guidelines
- Easily export data for audit trail
- Full traceability (each decision is name/date/time stamped) – eliminates tracking by hand
All information required to review variants and provide clinical interpretation presented in one view
- All information provided in one window to review each variant (read counts, quality info, BAM cartoon, pile-ups, platform recommendation, etc.)
- Easily review a variant in the BAM pile-up (sorted and color-coded)
- Trust but Verify – the software verifies that the variant caller didn’t miss anything (as well as detecting regions of local low coverage) by introspecting the BAM file
- Integrated clinical decision support powered by FDA, NCCN, ASCO and My Cancer Genome data
- Review relevant clinical trials
Template driven based on rules derived from FDA, NCCN, ASCO and My Cancer Genome
- Report leverages extensible rules engine powered by FDA, NCCN, ASCO and My Cancer Genome
- Branded, customizable reports for each institution
- Create specific reports to meet the needs of your clients (Oncologist vs Molecular Tumor Board)
- Report can be integrated into EMR / LIS
Quickly review and validate the genomic analyst’s draft report, add comments, and medically sign off on final report
- Less time spent reviewing variants/literature
- Pathologist-friendly workflow with full audit trail
- Manage amendments and addenda
- Supports multiple sign offs for various test modes