What's Happening?
Circulogene, a precision oncology company based in Pensacola, Florida, has announced the launch of OncoGenDx, a comprehensive genomic profiling (CGP) assay for solid tumors. This new assay is designed to provide detailed molecular analysis of formalin-fixed paraffin-embedded (FFPE) tumor tissue across all solid tumor types. Built on Roche's AVENIO NGS platform and utilizing FoundationOne's bioinformatics pipeline, OncoGenDx examines 335 DNA genes and 72 RNA genes to identify various genetic alterations, including single nucleotide variants, insertions/deletions, copy number variations, and structural variants. The assay also reports on complex genomic signatures such as Tumor Mutational Burden, Microsatellite Instability, and Homologous Recombination Deficiency, which are crucial for targeted therapy and immunotherapy decisions. The launch of OncoGenDx reflects Circulogene's commitment to advancing precision oncology by integrating tissue and liquid capabilities into a unified solution, thereby enabling clinicians to make faster and more informed treatment decisions.
Why It's Important?
The introduction of OncoGenDx is significant for the field of oncology as it enhances the ability of clinicians to diagnose and monitor solid tumors with greater precision. By providing a comprehensive molecular analysis, the assay supports more personalized treatment plans, potentially improving patient outcomes. The integration of tissue and liquid biopsy capabilities into a single platform allows for a more streamlined diagnostic process, reducing the time required for decision-making. This advancement is particularly important in the context of precision medicine, where understanding the genetic makeup of tumors can lead to more effective and targeted therapies. The assay's ability to report on key genomic signatures also aids in identifying patients who may benefit from specific immunotherapies, thereby expanding treatment options and improving the quality of care.
What's Next?
With the launch of OncoGenDx, Circulogene is poised to enhance its role in the precision oncology market. The company plans to streamline the ordering process through direct submission and coordinate pathology retrieval via its Client Services team. Results from the assay are expected to be delivered within 10 to 14 days, supporting timely clinical decision-making and trial enrollment. As the assay gains traction, it may lead to increased adoption of comprehensive genomic profiling in clinical settings, further driving the shift towards personalized medicine. Additionally, the assay's capabilities could facilitate more robust longitudinal profiling, allowing for better monitoring of disease progression and treatment response over time.
