Circulogene Expands Solid Tumor Genomic Capabilities with Launch of OncoGenDx Tissue Assay

PENSACOLA, Fla., Oct. 7, 2025 /PRNewswire/ -- Circulogene today announced the national launch of OncoGenDx, an innovative tissue-based comprehensive genomic profiling (CGP) assay that delivers expanded insights into all solid tumors. 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.

"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.

About Circulogene

Circulogene is a precision oncology company committed to advancing molecular diagnostics that are clinically actionable, operationally accessible, and aligned to real-world workflows. Based in Pensacola, FL, Circulogene's portfolio includes OncoGenLDx, the industry's only plasma-based test reporting PD-L1 expression, and LungLifeAI, a FISH-based assay supporting risk stratification for incidental lung nodules. The company's newly launched OncoGenDx expands these capabilities to tissue samples, offering clinicians a unified view of tumor biology.

For more information, visit www.circulogene.com

SOURCE Circulogene