FDA ClearedA comprehensive assay for solid tumor profiling in tissue

PGDx elio™ tissue complete is a comprehensive, in-vitro diagnostic, next generation sequencing (NGS) assay that identifies key genomic alterations and guideline supported biomarkers in solid tumors using a 500+ gene panel. PGDx elio™ tissue complete is the industry’s first and only NGS diagnostic kit for comprehensive tumor profiling that is FDA-cleared for use in labs across the country.

Designed to be used in labs across the globe, the PGDx elio™ testing platform including automated bioinformatics ensures consistent, high-quality testing for patients with advanced cancer. Molecular pathology labs can offer PGDx elio™ tissue complete testing to their oncologists and their patients. Fast, reliable, and comprehensive results help to inform critical treatment decisions and cancer care pathways.

This assay identifies somatic mutations with high accuracy and sensitivity, providing information on single nucleotide variants, insertions/deletions (indels), amplifications, translocations, microsatellite instability (MSI) status and tumor mutation burden (TMB) to qualified healthcare professionals for use in accordance with NCCN guidelines.

  • Identifies clinically actionable and functionally important mutations and alterations across all solid tumor types increasing confidence in treatment decisions
  • Reports microsatellite instability (MSI) status and tumor mutation burden (TMB) to assess potential response to immuno-oncology therapies
  • Identifies sequence mutations (single base substitutions and indels), amplifications, translocations, MSI status, and TMB
  • Includes a comprehensive list of NCCN guideline target genes

Benefits of PGDx's FDA-Cleared Comprehensive Tissue Panel

THE FIRST FDA-CLEARED
COMPREHENSIVE GENOMIC
PROFILING DIAGNOSTIC KIT
FOR CLINICAL USE

​REPORTS TUMOR MUTATION BURDEN(TMB)
MICROSATELLITE INSTABILITY (MSI),
COMPLEX STRUCTURAL ALTERATIONS,
& AMPLIFICATIONS

IDENTIFIES MANY
POTENTIAL THERAPY
TARGETS FROM A SINGLE SAMPLE

DEVELOPED UNDER
DESIGN CONTROL TO
MEET REGULATORY STANDARDS

UTILIZES ROBUST TURN-KEY
BIOINFORMATICS PIPELINE
TO KEEP DATA AND RESULT
REPORTING IN-HOUSE

Key Metrics

500+ Full Coding Genes for Sequence Mutations
4-5 Days Turn-Around Time
2,500X Sequencing Coverage
NCCN Includes All Solid Tumor Guideline-Recommended Genes 
 
TMB & MSI Proprietary Calling Methods