Personalis, a provider of advanced genomics for precision oncology, received a final Medicare coverage determination for its NeXT Dx comprehensive tumor genomic profiling assay, providing access for the nation’s 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), according to the company. In addition, NeXT Dx utilizes paired tumor and non-tumor samples to report more accurate results.
Coverage for NeXT DX was extended effective Aug. 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.
Further reading: Personalis’ MRD Assay Detects ctDNA in Lung Cancer Patients Earlier
“We are thrilled to receive our first coverage determination with our ultra-comprehensive NeXT Dx test, which offers treating physicians a better chance of finding an FDA-approved therapy or clinical trial for patients with advanced cancer,” says Chris Hall, president and CEO at Personalis. “With our recent early access launch of the ultra-sensitive NeXT Personal Dx test, which is designed to detect molecular residual disease and cancer recurrence, we continue our momentum in offering products that provide deep genomic insights throughout a cancer patient’s entire journey.”