Strata Oncology, Ann Arbor, Mich, announced that Palmetto GBA, a Medicare Administrative Contractor (MAC), has established coverage of the StrataNGS test for patients with advanced stages (III or IV), recurrent, relapsed, refractory, and/or metastatic solid tumors.
StrataNGS is a comprehensive genomic profiling (CGP) test that features leading performance on small tumor tissue samples. The 429-gene assay is performed on co-isolated RNA and DNA. Single-/multi-nucleotide variants (SNVs), short insertions and deletions (indels), copy number alterations (CNAs; amplifications and deep deletions), microsatellite instability (MSI) status, gene fusions, and tumor mutation burden (TMB) are assessed simultaneously.
A recent study presented at the 2020 Annual Meeting of the American Society of Clinical Oncology (ASCO) showed that the performance of StrataNGS on small tumor tissue samples may enable access to testing for more than double the number of patients compared to other leading comprehensive genomic profiling (CGP) tests. The results from an analysis of data collected in the Strata Trial demonstrated that only 43% of >20,000 consecutive tumor tissue samples received for CGP met tissue surface area requirements for leading commercial hybrid-capture-CP tests. StrataNGS, a PCR-CGP test, delivered reportable results in 93% of all samples received.
“Medicare coverage of StrataNGS is an important milestone toward enabling broader access to comprehensive genomic profiling for patients with cancer,” says Dan Rhodes, PhD, co-founder and CEO of Strata Oncology. “Tumor tissue availability is a major barrier to test access. 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.”
StrataNGS has been available to patients as part of the Strata Trial, an observational trial conducted by Strata Oncology at over 125 hospitals nationwide. The company will continue to focus on its health system network before pursuing a broader commercial launch in 2021.
For more information, visit Strata Oncology.
- Rhodes D, Hovelson DH, Suga JM, et al. PCR-based comprehensive genomic profiling (PCR-CGP): Feasibility from >20,000 tumor tissue specimens (TTS) and predicted impact on actionable biomarker identification versus hybrid capture (H)-CGP and plasma (P)-CGP. J Clin Oncol. 2020;38:(suppl; abstr 3574). doi: 10.1200/JCO.2020.38.15_suppl.3574.