Natera gains 4.4% as Signatera enters melanoma trial with Diakonos

Natera Inc. and Diakonos Oncology will use Natera's Signatera minimal residual disease test to track molecular response in a Phase I/II trial of patients with refractory melanoma, the companies said Friday.

"With an FDA Fast Track designation in hand, DOC1021's path forward in refractory melanoma will benefit from early, high-quality evidence of activity," said Jay Hartenbach, president and chief operating officer of Diakonos Oncology. "Natera's Signatera test is the most trusted tumor-informed MRD platform in oncology, making them a natural partner to help evaluate molecular response in a population where imaging often lags the biology."

The DOC-RM trial, which began enrollment in May, is evaluating DOC1021 (dubodencel), a first-in-class personalized dendritic cell immunotherapy that received FDA Fast Track designation for unresectable or metastatic cutaneous melanoma. Under the partnership, Signatera will analyze circulating tumor DNA at multiple timepoints during and after treatment. Refractory melanoma represents a significant unmet need — many patients either do not respond to existing immunotherapies or develop resistance, and radiographic assessment can be difficult in this population.

Shares of Natera rose 4.4% since the announcement, giving the Austin, Texas-based company a market capitalization of about $32 billion. The collaboration expands Signatera's application into clinical-stage immunotherapy programs for difficult-to-treat cancers, where serial ctDNA monitoring may provide earlier insight into molecular response than traditional imaging. The minimal residual disease testing market was valued at $1.7 billion in 2025 and is expected to grow at a 12% compound annual rate through 2034, according to Precedence Research.

The partnership follows the FDA approval of Signatera CDx as a companion diagnostic for use with adjuvant atezolizumab (Tecentriq) in muscle-invasive bladder cancer, the first companion diagnostic approval in the blood-based MRD testing space. Natera has also launched the SIGNAL-ER 101 trial using Signatera for MRD-guided de-escalation in early-stage breast cancer.

"Signatera is uniquely positioned to help biopharma partners evaluate molecular response throughout the course of therapy, and we are thrilled to partner with Diakonos on this exciting program," said Eric Matthews, general manager of BioPharma at Natera. "By assessing MRD status across multiple timepoints, this collaboration has the potential to provide deep insight into treatment response dynamics and support future development efforts for patients with difficult-to-treat cancers."

The collaboration gives Natera an opportunity to demonstrate the value of ctDNA monitoring in a setting where traditional radiographic assessments may not fully capture treatment response. Investors will watch for interim data from the DOC-RM trial and further expansion of Signatera into biopharma drug development programs.

This article is for informational purposes only and does not constitute investment advice.