OncoGenDx analyzes 335 DNA genes and 72 RNA genes using next-generation sequencing technology to support treatment decisions.
Circulogene has launched OncoGenDx, a tissue-based genomic profiling assay designed to analyze all solid tumor types and support precision oncology treatment decisions.
The next-generation sequencing assay analyzes formalin-fixed paraffin-embedded tumor tissue samples, interrogating 335 DNA genes and 72 RNA genes to identify single nucleotide variants, insertions/deletions, copy number variations, and structural variants including actionable fusions.
Built on Roche’s AVENIO NGS platform and leveraging FoundationOne’s bioinformatics pipeline, OncoGenDx also reports three genomic signatures: tumor mutational burden, microsatellite instability, and homologous recombination deficiency to support both targeted therapy and immunotherapy decision-making.
“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,” says Mike Mullen, CEO of Circulogene, in a release.
Laboratory Operations and Turnaround Time
The assay is performed in Circulogene’s CLIA-certified laboratory in Pensacola, Florida. Results are delivered as a unified report typically within 10 to 14 days of sample submission.
Ordering is streamlined through direct submission to Circulogene, with the option to have pathology retrieval coordinated by the company’s client services team. PD-L1 immunohistochemistry testing using the 22C3 clone is available as an add-on service using Combined Positive Score scoring.
The platform supports clinical decision-making, trial enrollment, and longitudinal profiling for oncology patients across all solid tumor types.
OncoGenDx joins Circulogene’s existing oncology testing portfolio, which includes OncoGenLDx, a plasma-based test that reports PD-L1 expression, and LungLifeAI, a targeted solution for risk-stratifying incidental lung nodules.
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