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.
THE FIRST FDA-CLEARED
PROFILING DIAGNOSTIC KIT
FOR CLINICAL USE
REPORTS TUMOR MUTATION BURDEN(TMB)
MICROSATELLITE INSTABILITY (MSI),
COMPLEX STRUCTURAL ALTERATIONS,
TARGETS FROM A SINGLE SAMPLE
DESIGN CONTROL TO
MEET REGULATORY STANDARDS
UTILIZES ROBUST TURN-KEY
TO KEEP DATA AND RESULT