On October 7, 2025 Circulogene reported the national launch of OncoGenDx, an innovative tissue-based comprehensive genomic profiling (CGP) assay that delivers expanded insights into all solid tumors (Press release, Circulogene, OCT 7, 2025, View Source [SID1234656488]). Designed to complement Circulogene’s existing portfolio—including OncoGenLDx, the industry’s only plasma-based test reporting PD-L1 expression, and LungLifeAI, a targeted solution for risk stratifying incidental lung nodules—the new assay reflects Circulogene’s ongoing commitment to advancing precision oncology with fast, modular, and clinically actionable testing options.
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"OncoGenDx reflects Circulogene’s commitment to innovation that simplifies the diagnostic landscape," said Mike Mullen, CEO of Circulogene. "By integrating tissue and liquid capabilities into a unified solution, we’re enabling clinicians to make faster, more confident treatment decisions—whether they’re evaluating initial diagnoses or monitoring disease progression."
About OncoGenDx
OncoGenDx is a next-generation sequencing (NGS) assay designed to deliver a comprehensive molecular analysis of formalin-fixed paraffin-embedded (FFPE) tumor tissue across all solid tumor types. Built on Roche’s AVENIO NGS platform and leveraging FoundationOne’s bioinformatics pipeline, the assay interrogates 335 DNA genes and 72 RNA genes to identify single nucleotide variants (SNVs), insertions/deletions (Indels), copy number variations (CNVs), and structural variants (SVs), including actionable fusions. It also reports three complex genomic signatures—Tumor Mutational Burden (TMB), Microsatellite Instability (MSI), and Homologous Recombination Deficiency (HRD)—to support both targeted therapy and immunotherapy decision-making. PD-L1 IHC (22C3 clone) is also available as an add-on service using CPS scoring.
Ordering is streamlined through direct submission to Circulogene, with the option to have the pathology retrieval coordinated by the Circulogene Client Services team. Results are delivered as a unified report typically within 10–14 days. The OncoGenDx platform is performed in Circulogene’s CLIA-certified laboratory and supports clinical decision-making, trial enrollment, and longitudinal profiling.