New Natera Publication Bolsters Evidence for Extended Surveillance with Signatera in Breast Cancer

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced a new publication in JCO Precision Oncology reporting on the ability of its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, to detect recurrence early in patients with early-stage breast cancer. The full study can be found here.

The study evaluated a total of 1,136 prospectively collected and banked plasma samples from 156 early-stage breast cancer patients enrolled in the multi-site Exploratory Breast Lead Interval Study (EBLIS). Patients were followed for up to 12 years after surgery and adjuvant chemotherapy, with blood samples collected semi-annually and then analyzed using Signatera. Key findings include:

• Signatera detected relapse up to 38 months earlier than imaging (median lead time 10.5 months), with an overall sensitivity of 88.2% (30/34)
• Relapse-free survival (RFS) and overall survival (OS) were significantly worse in patients who were ctDNA-positive, regardless of hormone receptor and HER2 subtype (HR 52.98 and 53.69, respectively). In a multivariate analysis, ctDNA status was the most significant factor associated with RFS and OS.

“The EBLIS study shows that post-operative monitoring with Signatera can detect recurrence much earlier than scans, opening up a critical window for early therapeutic intervention and clinical trials focused on molecular recurrence,” said Charles Coombes, MD, PhD professor of medical oncology at the Imperial College London and principal investigator of the EBLIS study. “Additionally, we demonstrate the value of longitudinal testing in providing reassurance to breast cancer patients, as those who test serially ctDNA-negative show better clinical outcomes.”

Breast cancer is the most common cancer in women in the U.S. and the second leading cause of cancer death in women.¹ The current standard of care for most patients with early-stage breast cancer consists of surgery and adjuvant chemotherapy and/or endocrine therapy.^2,3 However, patients with early-stage breast cancer experience a rate of local recurrence of roughly 15% and distant metastases of 21% after primary treatment.⁴

“This expanded EBLIS study reinforces the importance of early recurrence detection with Signatera and the potential to improve care management for patients with breast cancer,” said Minetta Liu, MD, chief medical officer of oncology. “The findings also bolster the evidence for long-term monitoring of high-risk breast cancer patients, who often face late recurrences.”