Summary: Aventa Genomics has received CMS approval for 2025 Clinical Laboratory Fee Schedule pricing of its FusionPlus test, an NGS tool using 3D genomics for cancer diagnostics.
Key Takeaways:
- Innovative Technology: The Aventa FusionPlus test uses 3D genomics to amplify detection signals 100- to 1000-fold, identifying novel gene fusions and biomarkers missed by traditional RNA sequencing and FISH methods.
- Milestone Achievement: The favorable CMS pricing, effective January 1, 2025, marks a significant step in improving reimbursement and expanding access to this advanced cancer diagnostic tool.
- Enhanced Patient Outcomes: By enabling precise identification of actionable biomarkers, Aventa FusionPlus aims to support better diagnosis and management of solid tumors, improving clinical decision-making and patient care.
Aventa Genomics, a clinical laboratory deploying 3D genomics to improve patient outcomes, has received a favorable final pricing determination for the 2025 Centers for Medicare and Medicaid Services (CMS) Clinical Laboratory Fee Schedule (CLFS). The pricing determination is for the Aventa FusionPlus test, a next-generation sequencing test that detects gene fusions, translocations, and rearrangements in solid cancers from formalin-fixed, paraffin-embedded (FFPE) tumor tissue.
The Aventa FusionPlus Test
The Aventa FusionPlus test incorporates 3D genomics technology, leveraging preservation of the spatial proximity of fused and rearranged genes for a 100- to 1000-fold signal amplification in the identification of novel breakpoints and fusion partners. As a result, the test improves upon conventional testing methods such as RNA sequencing and fluorescent in situ hybridization (FISH) by revealing actionable biomarkers that these methodologies detect but also biomarkers that are missed by them. The test utilizes proprietary analysis and reporting platforms to deliver a comprehensive assessment of the tumor.
“Receiving favorable pricing from CMS is a critical milestone in the reimbursement journey for Aventa FusionPlus testing,” says Chris Roberts, executive director for Aventa Genomics. “This determination highlights the importance of innovation in cancer diagnostics and enables us to continue to expand clinician access to our novel 3D genomics-based test. We believe integration of Aventa FusionPlus in the diagnosis and management of patients with solid tumors will ultimately improve outcomes.”
The Aventa FusionPlus test was granted a Proprietary Laboratory Analysis (PLA) code earlier this year and received initial pricing from its Medicare administrative contractor, First Coast Service Options, Inc. CLFS pricing for the Aventa FusionPlus test will be effective Jan. 1, 2025. The test requisition form and additional information for providers are available at www.aventagenomics.com.
