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RaDaR ST analytical validation

  • Elliott, Mitchell J., et al. Longitudinal Evaluation of Circulating Tumor DNA in Patients Undergoing Neoadjuvant Therapy for Early Breast Cancer Using a Tumor-Informed Assay. Nature Commun., vol. 16, no. 1, 2025, article 1837.
  • Flach, S., et al., Personalized ctDNA analysis for detection of residual disease and recurrence in surgically treated HNSCC patients. NPJ Precis Oncol, 2026.
  • Flach, S., et al., Liquid BIOpsy for MiNimal RESidual DiSease Detection in Head and Neck Squamous Cell Carcinoma (LIONESS)-a personalised circulating tumour DNA analysis in head and neck squamous cell carcinoma. Br J Cancer, 2022.
  • NeoGenomics data on file. Sensitivity demonstrated across four independent analytical and clinical validation studies, with detection of LOD95 at 11 parts per million (ppm) and under certain study-specific conditions, as low as 1 ppm.

RaDaR ST clinical evidence

  • Flach, S., Pipinikas, C., Huberty, T. et al. Personalized ctDNA analysis for detection of residual disease and recurrence in surgically treated HNSCC patients. npj Precis. Onc. 10, 103 (2026)
  • Yoo, TKR, Santos K, Lipsyc-Sharf M et al., Circulating tumor DNA and late recurrence in high-risk, hormone receptor-positive, HER2-negative breast cancer: An updated analysis of the CHiRP study, J Clin Oncol 43, 3055 (2025)
  • Gale D, Heider K, Ruiz-Valdepenas A, et al. Residual ctDNA after treatment predicts early relapse in patients with early-stage non-small cell lung cancer. Ann Oncol. 2022;33(5):500-510. doi:10.1016/j.annonc.2022.02.007
  • Lipsyc-Sharf M, de Bruin EC, Santos K, et al. Circulating Tumor DNA and Late Recurrence in High-Risk Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer. J Clin Oncol. 2022;40(22):2408-2419. doi:10.1200/JCO.22.00908
  • Flach S, Howarth K, Hackinger S, et al. Liquid BIOpsy for MiNimal RESidual DiSease Detection in Head and Neck Squamous Cell Carcinoma (LIONESS)-a personalised circulating tumour DNA analysis in head and neck squamous cell carcinoma. Br J Cancer. 2022;126(8):1186-1195. doi:10.1038/s41416-022-01716-7
  • 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. doi:10.1038/s41591-022-02199-y
  • Coakley M, Villacampa G, Sritharan P, et al. Comparison of Circulating Tumor DNA Assays for Molecular Residual Disease Detection in Early-Stage Triple-Negative Breast Cancer. Clin Cancer Res. 2024;30(4):895-903. doi:10.1158/1078-0432.CCR-23-2326
  • 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. Published 2024 Mar 27. doi:10.1038/s41467-024-46961-x
  • 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. doi:10.1016/S0140-6736(23)02268-7
  • Genta S, Araujo DV, Hueniken K, et al. Bespoke ctDNA for longitudinal detection of molecular residual disease in high-risk melanoma patients. ESMO Open. 2024;9(11):103978. doi:10.1016/j.esmoop.2024.103978
  • Sanz-Garcia E, Zou J, Avery L, et al. Multimodal detection of molecular residual disease in high-risk locally advanced squamous cell carcinoma of the head and neck. Cell Death Differ. 2024;31(4):460-468. doi:10.1038/s41418-024-01272-y
  • Elliott MJ, Echelard P, Pipinikas C, et al. Longitudinal evaluation of circulating tumor DNA in patients undergoing neoadjuvant therapy for early breast cancer using a tumor-informed assay. Nat Commun. 2025;16(1):1837. Published 2025 Feb 21. doi:10.1038/s41467-025-56658-4
  • Herbst RS, John T, Grohé C, et al. Molecular residual disease analysis of adjuvant osimertinib in resected EGFR-mutated stage IB-IIIA non-small-cell lung cancer. Nat Med. 2025;31(6):1958-1968. doi:10.1038/s41591-025-03577-y
  • Schuurbiers MMF, Smith CG, Hartemink KJ, et al. Recurrence prediction using circulating tumor DNA in patients with early-stage non-small cell lung cancer after treatment with curative intent: A retrospective validation study. PLoS Med. 2025;22(4):e1004574. Published 2025 Apr 15.
  • 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. Published 2025 Aug 22. doi:10.1038/s41698-025-01084-4
  • Fuentes-Antrás J, Elliott MJ, Main SC, et al. Personalized ctDNA monitoring in metastatic HR+/HER2- breast cancer patients during endocrine and CDK4/6 inhibitor therapy. NPJ Breast Cancer. 2025;11(1):74. Published 2025 Jul 19. doi:10.1038/s41523-025-00783-2
  • Cabel L, An JA, Kim HK, et al. Monitoring of circulating tumor DNA in patients with stage II-III breast cancer treated with neoadjuvant chemotherapy. NPJ Breast Cancer. 2026;12(1):22. Published 2026 Jan 29. doi:10.1038/s41523-025-00878-w
  • Feng J, Khan S, Waddell TK, et al. Identifying Patients With High-Risk Stage I NSCLC Using a Tumor-Informed Plasma ctDNA Assay. J Thorac Oncol. Published online February 21, 2026. doi:10.1016/j.jtho.2026.103645
  • Strum S, Murray C, Genta S, Sanz-Garcia E, Razak A, Lheureux S, Pipinikas C, Wang BX, Chevalier A, Smith CG, et al. Pan-Cancer Pre-Treatment ctDNA Detection Using a Highly Sensitive Tumor-Informed Assay. International Journal of Molecular Sciences. 2026; 27(9):3979.
  • Smith C et al. Exploration of tumor-informed ctDNA detection and dynamics in a real-world cohort of colorectal cancer patients from the MD Anderson Cancer Center. Clin Oncol 44, 2026 (suppl 16; abstr e15658). doi: 10.1200/JCO.2026.44.16_suppl.e15658
  • Tie J, et al. Circulating tumor DNA analysis guiding adjuvant therapy in stage II colon cancer. N Engl J Med. 2022;386(24):2261-2272. doi:10.1056/NEJMoa2200075.
  • Tie J, et al. Circulating tumor DNA analysis guiding adjuvant therapy in stage II colon cancer: 5-year outcomes of the randomized DYNAMIC trial. Nat Med. 2025;31(5):1509-1518. doi:10.1038/s41591-025-03579-w
  • NeoGenomics data on file. Sensitivity demonstrated across four independent analytical and clinical validation studies, with detection of LOD95 at 11 parts per million (ppm) and under certain study-specific conditions, as low as 1 ppm.