Personalis, Inc. announced it has received a final Medicare coverage determination for its NeXT Dx ultra-comprehensive tumor genomic profiling assay, providing access for the nation?s 66 million Medicare and Medicare Advantage beneficiaries. Matching patients to their optimal cancer therapy requires a testing platform that can accurately report a broader range of clinically actionable genomic alterations. NeXT Dx analyzes a tumor?s entire exome (DNA) and transcriptome (RNA) to uncover deeper insights into therapy selection, including RNA-based fusions and advanced biomarkers that smaller panels might miss, such as tumor mutational burden (TMB) and microsatellite instability (MSI).

In addition, NeXT Dx utilizes paired tumor and non-tumor samples to report more accurate results. Coverage for NeXT DX was extended effective August 29, 2023, under the Palmetto GBA MolDx program foundational Local Coverage Determination (LCD) L38119 (?Next-Generation Sequencing for Solid Tumors?). Personalis estimates that approximately half of new solid tumor cancer cases will be diagnosed in patients covered by Medicare.