Translational Software

What Translational Software does

Translational Software, founded in 2009 and headquartered in Mercer Island, Washington, is a clinical decision support software company focused exclusively on pharmacogenomics (PGx). The company develops and sells the PGx Toolkit, a laboratory software platform that enables genetic testing laboratories to develop and validate CLIA- and MolDX-compliant pharmacogenomic laboratory developed tests (LDTs). The toolkit ingests raw genetic data from multiple instrument platforms (VCF, arrays, CSV, LIMS, HL7), normalizes it into standardized, traceable genetic results, and deterministically maps genotypes, diplotypes, and activity scores to curated clinical recommendations drawn from CPIC, FDA, and DPWG guidance, producing audit-ready reports with full provenance.

The architecture separates a cloud-hosted Knowledge Layer (a REST API serving continuously updated clinical content) from an on-premise execution layer that handles patient demographics, report generation, and validation workflows. This design ensures protected health information (PHI) never leaves the customer environment, while still allowing the clinical content to be updated centrally. The toolkit is supported across the three dominant PGx instrument platforms through integration with Thermo Fisher Scientific, Illumina, and Agena Bioscience, and supports enterprise authentication via Microsoft and Google OAuth.

Translational Software operates a B2B enterprise sales motion targeting clinical genetic testing laboratories. Distribution is direct and consultative, with demo requests and 30-minute Microsoft Bookings consultations routed by buyer role (Lab Director, Pathologist, QA/Compliance, Informatics/IT, Procurement). Pricing is quote-based and not publicly disclosed; the revenue model is a subscription toolkit license, with API-first integration available for embedding into lab workflows. The company is privately held with no disclosed funding rounds, institutional investors, parent company, or revenue, and operates with 11-50 employees led by founder/CEO Don Rule.

Name

Translational Software

Legal name

Translational Software, Inc.

Website

https://translationalsoftware.com

Company type

Private

Founded year

2009

Operating status

Operating

Headcount range

11–50 employees

Short description

Translational Software provides the PGx Toolkit, a pharmacogenomics decision support platform that enables genetic testing laboratories to develop CLIA- and MolDX-compliant LDTs with audit-ready, traceable clinical reporting and PHI-isolated on-premise execution.

Ownership category

akta.pro rank

Product category

Clinical Decision Support Software

NAICS

Software Publishers (513210), Medical Laboratories (621511), Computer Systems Design and Related Services (54151)

SIC

Services-Prepackaged Software (7372), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Pharmacogenomics (PGx) Decision Support (HLAAANAB)

akta.pro secondary industry

Quality, Compliance & Validation Software for Labs (GxP/CSV, eQMS for QC Labs) (HLAGAJAI)

Keywords

• Pharmacogenomics software
• Clinical decision support
• Laboratory developed tests
• Genetic data normalization
• Pharmacogenomic reporting

Headquarters

HQ city

Bellevue

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Software

Cost components

Personnel, Technology or R&D, Marketing or Sales, Infrastructure, Operations

Revenue model

1. PGx Toolkit Licensing: Software toolkit licensing model where genetic testing laboratories deploy the solution within their environment. Pricing likely subscription-based given enterprise sales motion and consultative demo approach.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels5 records

Core offering

Translational Software provides the PGx Toolkit, a laboratory software platform that ingests raw genetic data (VCF, arrays, instrument outputs, LIMS), normalizes it into standardized genotypes/diplotypes/activity scores, deterministically maps results to curated guidance from CPIC, FDA, and DPWG, and generates audit-ready reports. The toolkit runs within the customer's environment so that PHI never leaves the lab, while a cloud-hosted knowledge API provides continuously updated clinical content. It is purpose-built to help genetic testing laboratories develop and validate CLIA- and MolDX-compliant pharmacogenomic LDTs.

Product overview

Translational Software offers a single unified product: the PGx Toolkit. This is a laboratory software platform that enables genetic testing laboratories to process pharmacogenomic data from any source (VCF, arrays, instrument outputs), match results to curated clinical guidance from CPIC, FDA, and DPWG, and generate audit-ready reports. The architecture separates cloud-based knowledge services (the API providing curated pharmacogenomic insights and continuously updated clinical content) from on-premise execution (patient demographics, report generation, and validation workflows). The toolkit is designed to keep all PHI at the customer site while providing a traceable, versioned, and defensible analytical pipeline.

Differentiator

Problem solved

Functional benefit

Brands

• PGx Toolkit: A toolkit that enables genetic testing laboratories to develop and validate CLIA- and MolDX-compliant pharmacogenomic LDTs while documenting and demonstrating every analytical step.

Products and services

• PGx Toolkit A laboratory software toolkit that enables clinical genetic testing laboratories to process raw pharmacogenomic data from any platform, map it deterministically to CPIC/FDA/DPWG guidance, and produce audit-ready reports for CLIA- and MolDX-compliant LDTs, while keeping all PHI within the customer environment.

Quantifiable outcome

• Supports CLIA- and MolDX-compliant pharmacogenomic LDT development
• +1 more outcomes

Segments4 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

Yes

API docs

API detail

Core technology

AI maturity

App detail

Integration7 records

AI capability2 records

Feature5 records

Partnerships

Three partnerships are on record, tiered core.

• Thermo Fisher ScientificcoreTechnology or IntegrationThermo Fisher Scientific is a supported platform partner. The PGx Toolkit normalizes results from Thermo Fisher's pharmacogenomics portfolio spanning targeted PCR assays, genome-wide microarrays, and next-generation sequencing. Labs using Thermo Fisher instruments can integrate with the PGx Toolkit to process and interpret results.
• IlluminacoreTechnology or IntegrationIllumina is a supported platform partner. The PGx Toolkit works with Illumina's ecosystem of microarrays, high-throughput sequencing platforms, and informatics designed for PGx workflows. Integration enables labs to process Illumina-generated data through the compliance-ready pipeline.
• Agena BiosciencecoreTechnology or IntegrationAgena Bioscience is a supported platform partner. The PGx Toolkit integrates with the MassARRAY System using MALDI-TOF mass spectrometry for high-throughput, cost-effective genetic analysis. Labs can incorporate results from Agena instruments into the compliant workflow.

Scale indicators1 record

Recent moves5 records

Expansion highlights5 records

Emerging players

• Sophia Genetics: SOPHiA GENETICS provides clinical genomics interpretation software used by diagnostic labs across hereditary, oncology, and pharmacogenomics use cases. Partial overlap with Translational Software's PGx interpretation focus, but broader across clinical genomics.
• Genomind: Genomind provides a PGx testing service (Professional PGx) and clinician-facing reports that combine genetic results with curated drug-gene guidance. Comparable in clinical-PGx focus, but operates a lab service model rather than a pure software toolkit.

Direct peers

• Coriell Life Sciences: Coriell Life Sciences operates a pharmacogenomics decision-support service (genePGx) that helps clinicians interpret PGx results with curated dosing guidance. Directly comparable to Translational Software's PGx Toolkit as another CPIC-grounded PGx CDS offering for laboratory and clinical customers.
• ActX: ActX offers a clinical pharmacogenomics decision support service that delivers PGx insights to clinicians based on patient DNA results. Directly comparable to Translational Software as a curated, evidence-based PGx decision support offering for clinical and lab customers.
• Fabric Genomics (Velsera): Fabric Genomics, now part of Velsera, delivers clinical genomics interpretation software for hereditary and somatic testing. Overlaps with Translational Software as a clinical-grade genomics interpretation platform for diagnostic labs requiring regulatory-grade outputs.
• 2bPrecise: 2bPrecise provides a precision-medicine decision support platform integrated with EHR and lab information systems, including pharmacogenomic content. Directly comparable to Translational Software's PGx Toolkit as another PGx interpretation and CDS layer for clinical/lab customers.
• YouScript (Genelex / Invitae): YouScript/Genelex has long offered PGx clinical decision support that maps genetic results to drug and dosing recommendations. Directly comparable to Translational Software as a CPIC-aligned PGx interpretation platform serving labs and clinicians.

Broad incumbents

• Illumina Clinical Informatics: Illumina is a listed platform partner whose ecosystem (microarrays, sequencing, informatics) is supported by the PGx Toolkit. Comparable as a broader genomics platform that could bundle or compete with PGx interpretation layers.
• Thermo Fisher Scientific (PGx/One Lambda): Thermo Fisher is a strategic integration partner whose PGx reagents and instruments are normalized by the PGx Toolkit. A larger life-sciences incumbent offering overlapping PGx testing and informatics capabilities to clinical labs.
• Sema4 / GeneDx: Sema4 (now part of GeneDx) operates a clinical genomics lab and interpretation platform serving PGx and hereditary testing customers. A larger incumbent offering both lab services and clinical genomics software, relevant as a competitor-and-customer archetype for PGx lab customers.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights5 records

Customer concentration

• Xx.com/translationalx
• Facebookfacebook.com/translationalsoftware
• LinkedInlinkedin.com/company/translational-software

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Translational Software