Circulogene Enhances Genomic Testing with OncoGenDx Tissue Assay Launch

Circulogene, a prominent player in precision oncology, recently announced the nationwide launch of OncoGenDx, a remarkable tissue-based comprehensive genomic profiling (CGP) assay. This innovative tool is specifically designed to provide clinicians with deeper insights into solid tumors, enhancing the existing diagnostic landscape and integrating seamlessly with Circulogene’s current portfolio.

A New Era in Tumor Analysis



OncoGenDx promises to revolutionize the way oncologists evaluate and treat solid tumors. This next-generation sequencing (NGS) assay is engineered to carry out extensive molecular analyses of formalin-fixed paraffin-embedded (FFPE) tumor tissues across all categories of solid tumors. By utilizing Roche's AVENIO NGS platform and FoundationOne's advanced bioinformatics infrastructure, OncoGenDx examines 335 DNA genes and 72 RNA genes, aiming to spot single nucleotide variants (SNVs), insertions/deletions (Indels), copy number variations (CNVs), and structural variants (SVs), including notable fusions.

Moreover, it evaluates three complex genomic signatures: Tumor Mutational Burden (TMB), Microsatellite Instability (MSI), and Homologous Recombination Deficiency (HRD). These tools are indispensable for aiding decisions around targeted therapy and immunotherapy, thus facilitating a more personalized treatment strategy.

Supporting Clinician Efficiency



One of Circulogene’s overarching goals with the OncoGenDx assay is to simplify the diagnostic process. According to Mike Mullen, CEO of Circulogene, the assay represents a crucial step towards integrating tissue and liquid capabilities into a single, efficient approach for clinicians. This streamlined method not only enables quicker diagnoses but also provides clinicians with more confidence in treatment decisions, whether they are evaluating initial findings or tracking disease progression.

Convenience is further enhanced through a simple ordering process where clinicians can submit requests directly to Circulogene’s services. Additionally, Circulogene offers the option of coordinating pathology retrieval through their Client Services team, ensuring a comprehensive approach from ordering to diagnosis. Test results are typically available within 10 to 14 days, serialized in a unified report that empowers clinicians to make informed decisions quickly.

Expanding Circulogene's Innovations



The launch of OncoGenDx expands the capabilities of Circulogene’s portfolio, which already includes OncoGenLDx, a unique plasma-based test that reports PD-L1 expression levels, and LungLifeAI, a specialized solution for assessing incidental lung nodules. This breadth of offerings positions Circulogene as a leader in the realm of molecular diagnostics, dedicated to advancing the practice of precision oncology altogether.

Circulogene, headquartered in Pensacola, Florida, is steadfast in its commitment to developing molecular diagnostic tools that are not only actionable but also operationally feasible and integrated into real-world healthcare workflows. Clinical trials and longitudinal profiling are also supported by this new platform, further solidifying its place in enhancing cancer care.

Conclusion



In summary, the introduction of the OncoGenDx tissue assay marks a substantial milestone in cancer diagnostics, signaling Circulogene’s dedication to innovating in genomic assays that cater to the pressing needs of healthcare professionals and patients alike. With such tools at their disposal, clinicians can look forward to making better-informed decisions in managing solid tumors, paving the way for more effective treatment pathways in oncology.

For more information about the OncoGenDx assay and Circulogene's offerings, please visit www.circulogene.com.

Topics Health)

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