AUSTIN, Texas | May 2026
Natera, Inc. announced a new collaboration with Diakonos Oncology Corp. to utilize its personalized molecular residual disease (MRD) test, Signatera™, in Diakonos’ ongoing Phase I/II DOC-RM clinical trial for patients with refractory melanoma. The partnership aims to evaluate molecular responses to the investigational dendritic cell therapy DOC1021 (dubodencel) through longitudinal circulating tumor DNA (ctDNA) monitoring during and after treatment.
Signatera to Monitor Molecular Response During Immunotherapy Treatment
Natera will perform serial ctDNA analyses using Signatera™ at multiple timepoints throughout the DOC-RM study. The trial, which began patient enrollment in May 2026, is evaluating DOC1021, a personalized dendritic cell-based immunotherapy that recently received FDA Fast Track designation for the treatment of unresectable or metastatic cutaneous melanoma. Researchers aim to determine whether ctDNA monitoring can provide early insights into treatment response and disease progression that may not be immediately visible through conventional imaging methods.
Collaboration Targets Significant Unmet Need in Refractory Melanoma
Diakonos Oncology is focusing on patients with refractory melanoma, a population that continues to face limited treatment options despite advances in immunotherapy. While checkpoint inhibitors and other immunotherapies have improved outcomes for many melanoma patients, a substantial number either fail to respond or eventually develop resistance. Because radiographic assessments can be difficult to interpret in immunotherapy-treated patients, molecular monitoring through ctDNA testing may offer a more sensitive approach for tracking disease dynamics and evaluating therapeutic effectiveness.
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Companies Highlight Potential of ctDNA-Guided Drug Development
Diakonos Oncology President and Chief Operating Officer Jay Hartenbach stated that incorporating Signatera™ into the DOC-RM trial could help generate early and meaningful evidence of DOC1021’s activity in a difficult-to-treat patient population. Natera General Manager of BioPharma Eric Matthews emphasized that Signatera’s tumor-informed MRD technology is well positioned to support biopharmaceutical partners by providing detailed insights into molecular response patterns throughout treatment. The collaboration is expected to contribute valuable data that could guide future clinical development efforts and improve therapeutic strategies for patients with advanced melanoma.
Source: Natera, Diakonos Oncology press release
