RaDaR ST for immunotherapy (IO) treatment
IO therapies are widely used across multiple solid tumor cancer types and stages. Common targets include PD-1/PD-L1 and CTLA-4, with a range of FDA-cleared targeted therapies. IO treatment response is primarily monitored using imaging and clinical assessment; however, the unique response patterns of IO therapy may create uncertainty during treatment assessment, as some patients may experience pseudoprogression, delayed response, and mixed response, which can make conventional assessment difficult to interpret and may complicate clinical decision-making.
Coverage is provided under LCD - MolDX: Plasma-Based Genomic Profiling in Solid Tumors (L38043).
Internal TAM market data on file.
Weber JS, Carlino MS, Khattak A, et al. Individualised neoantigen therapy mRNA-4157 (V940) plus pembrolizumab versus pembrolizumab monotherapy in resected melanoma (KEYNOTE-942): a randomised, phase 2b study. Lancet. 2024;403(10427):632-644.
Lynce F, Mainor C, Donahue RN, et al. Adjuvant nivolumab, capecitabine or the combination in patients with residual triple-negative breast cancer: the OXEL randomized phase II study. Nat Commun. 2024;15(1):2691.
van Dorp J, Pipinikas C, Suelmann BBM, et al. High- or low-dose preoperative ipilimumab plus nivolumab in stage III urothelial cancer: the phase 1B NABUCCO trial. Nat Med. 2023;29(3):588-592.
Ruiz-Torres DA, Merkin RD, Bryan ME, et al. Personalized circulating tumor DNA dynamics inform survival and response to immune checkpoint blockade in recurrent/metastatic head and neck cancer. NPJ Precis Oncol. 2025;9(1):298.
Limit of detection with 95% probability (LOD95) at 11 ppm; detection down to 1 part per million under study specific conditions (NeoGenomics data on file).