OncoGenDx

Circulogene OncoGenDx Tissue CGP Platform

Circulogene is pleased to offer OncoGenDx, a validated, multi-modal tumor profiling solution. This comprehensive tissue-based CGP platform builds on the success of Circulogene’s liquid biopsy program currently in use by thoracic and IP teams. Powered by Roche’s AVENIO sequencing chemistry and FoundationOne’s tertiary bioinformatics engine, OncoGenDx delivers robust biomarker insights across multiple testing modalities.

The assay supports a wide range of solid tumors, including key thoracic targets such as NSCLC, and is particularly effective when paired with Circulogene’s existing plasma-based CGP for longitudinal patient management.

OncoGenDx: Validated, multi-modal tumor profiling solution for precision oncology

Key Components:
• DNA Panel (AVENIO – 335 genes): SNVs, Indels, CNAs, Structural Variants + TMB, MSI, HRDsig
• RNA Fusion Panel (QIAseq – 72 genes): ALK, RET, ROS1, METex14, NRG1, FGFRs, etc.
• PD-L1 (22C3 clone): CPS scoring performed via IHC

All results unified into a single report (DNA + RNA + IHC), typically delivered within 7–14 days.

Why OncoGenDx

Key Benefits:

Leverages Existing Adoption

Builds upon your established use of Circulogene’s liquid biopsy in thoracic and IP workflows

Single-Lab, Dual-Modality Model

Enables integration of liquid and tissue CGP through one vendor — reducing turnaround time, report complexity, and inter-lab variability

Improved Clinical Concordance

Concordant interpretation across tissue and plasma tests enhances therapeutic alignment and simplifies tumor board decision-making

Additional Advantages:

Thoracic-Focused Panel Design

High coverage of driver mutations and fusions common in NSCLC and related pathologies

Customer-Focused Coordination

Hands-on support from the Circulogene client services team streamlines logistics, reduces follow-up burden, and supports rapid tissue retrieval

GENE LIST

Workflow & Ordering

Orders submitted via faxable requisition or through the existing online portal

Circulogene coordinates pathology retrieval directly or via portal

Remnant blocks or slides are returned to the pathology department post-analysis

Specimen Requirements

• FFPE tissue block or 10 unstained slides (H&E optional but preferred)
• Minimum 20% tumor content recommended
• Completed requisition form required
• Circulogene Customer Care team will coordinate specimen retrieval directly

14-Day Rule – Billing Clarification for Tissue Testing

The 14-day rule for molecular testing only applies to inpatient hospital cases. All thoracic/IP cases currently routed through Circulogene are outpatient-based, meaning billing proceeds normally without institutional reimbursement conflicts.