Translating genomic data
into actionable insights.

The new PGx Toolkit by Translational Software provides laboratory informatics that enables genetic testing laboratories to develop and validate pharmacogenomic LDTs within CLIA and MolDX laboratory workflows—while documenting and demonstrating every analytical step.

Built on CPIC, FDA, and DPWG guidance·PHI stays at the customer site
Three parts

Separation of concerns by design.

Your laboratory defines the panel, validates it, and accepts and signs out every result.

In the cloud

Workbench

  • Define your panel
  • Validate with a synthetic test kit and orthogonal testing
  • Build your knowledge package
In the lab

Local Utilities

  • Run on your own machine
  • Process to your configuration — data-driven, not a vendor default
  • Patient data stays on site
In the lab

Dashboard

  • Orchestrate each run
  • Record testing, decisions, controls, and sign-out
  • Nightly backup to your own storage

No call to TSI in the path of a sample — Local Utilities run entirely on your own machine.

What we do

Three things, done with rigor.

Data Normalization

From raw data to standardized genetic results

The Toolkit ingests results from your lab's secondary analysis software, already transformed from raw instrument data into discrete genotype calls, and applies analyte mapping that normalizes results from VCF or vendor specific files into standardized, traceable genetic results. Configurable to handle real-world lab variability without custom pipelines.

Diplotype Mapping

From normalized variants to lab determined diplotypes

Your lab builds the lookup tables for its panel and laboratory context in the Toolkit, including how ambiguous calls are flagged. Your laboratory validates and approves those tables before they're used, and reviews a summary of diplotype and activity score for every result — approving or modifying it. Lab decisions are captured so you can “show your work.”

Reporting

From approved results to reliable implications

The Toolkit looks up the most current information from the FDA, CPIC, DPWG — or your own content — against your lab's professionally verified test results, producing clear, efficient, and audit-ready reports with references so end users can arrive at their own conclusions.

Talk to our team.

Tell us what you're evaluating. We'll show you the content, the provenance, and how it fits your stack.

Request a demo →