Enriching Trial Populations
Stratify and enrich clinical trial populations for high-risk, ctDNA-positive patients most likely to benefit from therapy. MRD tests can help elucidate differences in outcomes on investigational therapeutics based on ctDNA positivity post-surgery, prior to investigational therapy initiation.
*image adapted from Nicholas C. Turner et al. Detection of circulating tumor DNA following neoadjuvant chemotherapy and surgery to anticipate early relapse in ER positive and HER2 negative breast cancer: Analysis from the PENELOPE-B trial. J Clin Oncol 41, 502-502(2023).
Therapeutic Monitoring
MRD tests provide real-time molecular insights for patient response to therapy, differentiating responders from non-responders. Follow response to investigational therapies prospectively in real-time, or retrospectively analyze samples in order to gain deeper insights into the trajectory of response to an investigational therapy.
*image adapted from van Dorp J et al. High- or low-dose preoperative ipilimumab plus nivolumab in stage III urothelial cancer: the phase 1B NABUCCO trial. Nat Med. 2023 Mar;29(3):588-592. doi: 10.1038/s41591-022-02199-y. Epub 2023 Feb 2. Erratum in: Nat Med. 2024 Jan;30(1):304.
Surrogate Endpoints
Use ctDNA as an objective measure to support earlier efficacy readouts for clinical trials. MRD tests provide molecular-level detection of residual disease, predicting patients most likely to experience disease recurrence or progression. Integrating MRD testing timepoints into trial designs allows for the inclusion of meaningful surrogate endpoints, such as ctDNA clearance, to support more robust and timely efficacy evaluations.
