NEW YORK – Strata Oncology announced Tuesday its StrataNGS comprehensive genomic profiling test is covered under a local coverage determination from Medicare Administrative Contractor Palmetto GBA.
The test is covered for patients with advanced stages, recurrent, relapsed, refractory, and/or metastatic solid tumors under Palmetto's general LCD for next-generation sequencing for solid tumors. The LCD is specific for solid tumor testing and "is exclusive of hematologic malignancies, circulating tumor DNA testing … and other cancer-related uses of NGS, such as germline testing" for patients with cancer, according to the LCD. The patient cannot have been previously tested by the same test for the same genetic content.
The LCD aligns Palmetto's coverage with a national coverage determination from the US Centers for Medicare and Medicaid Services covering NGS tests in patients with cancer.
StrataNGS is a comprehensive genomic profiling test that analyzes 429 genes and assesses single-/multi-nucleotide variants, short insertions and deletions, copy number alterations, microsatellite instability status, gene fusions, and tumor mutation burden simultaneously, Ann Arbor, Michigan-based Strata Oncology said in a statement. A recent study presented at the 2020 Annual Meeting of the American Society of Clinical Oncology found that StrataNGS had higher performance than comparable tests on small tumor tissue samples.
"Tumor tissue availability is a major barrier to test access," said Strata Oncology Cofounder and CEO Dan Rhodes. "With industry-low tumor tissue requirements, StrataNGS expands the number of patients that can receive tissue-based molecular profiling and potentially benefit from biomarker-guided targeted and immunotherapies."