NTRA News & Events

Natera announced a new collaboration with Diakonos Oncology Corp., a clinical-stage biotechnology company developing immunotherapies to treat challenging and aggressive cancers. As part of the collaboration, Signatera will be used to longitudinally assess molecular response in patients with refractory melanoma enrolled in Diakonos' DOC-RM Phase I/II investigational immunotherapy trial. The DOC-RM trial, which began enrollment in May, is evaluating DOC1021, a first-in-class, personalized dendritic cell investigational therapy that recently received Fast Track designation by the U.S. FDA in unresectable or metastatic cutaneous melanoma. With Signatera, Natera will conduct analyses of circulating tumor DNA at multiple timepoints during and following treatment.

Natera announced enrollment of the first patients in SIgnatera-Guided iNterventionAL-ER 101, a prospective, single-arm, multi-center study evaluating Signatera MRD-guided de-escalation in early-stage breast cancer. SIGNAL-ER 101 plans to enroll approximately 725 patients across 50 sites in the United States. Patients who test MRD-positive will receive endocrine therapy plus CDK4/6 inhibitors, while those who test MRD-negative will receive endocrine therapy alone with quarterly Signatera monitoring. Patients who become MRD-positive during surveillance will be eligible to initiate CDK4/6 inhibition at that time, consistent with the TOMR approach.

Natera announced a significant expansion of its operations. At its North Austin headquarters campus, Natera will unveil two major expansion projects: a sequencing facility, significantly increasing capacity; and an additional space in a second building within the same complex. Natera's facility is expected to have the largest sequencing capacity in the world. This new space will help enable the company to meet the increasing demand for its testing solutions, particularly in oncology where year-over-year volumes increased by more than 54% in the first quarter of 2026.

Natera announced that the Expand clinical trial has enrolled over 2,000 patients, more than doubling enrollment in the last 12 months. Expand is a prospective, blinded, multi-site clinical trial designed to study Natera's Fetal Focus single-gene noninvasive prenatal test. The trial was featured in an oral plenary session at the Society for Maternal-Fetal Medicine Expand Meeting in February 2026. "In developing Fetal Focus, our goal has been to expand the scope of what noninvasive prenatal testing can deliver," said Sheetal Parmar, SVP of Medical Affairs, Women's Health at Natera. "With more than 2,000 patients enrolled, EXPAND is helping to set a new standard for clinical evidence in single-gene NIPT, and we remain focused on generating high-quality data to support clinicians and the families they serve."