Natera, Inc. announced a new publication in JCO Precision Oncology reporting on the ability of its personalised and tumor-informed molecular residual disease (MRD) test, Signatera, to detect recurrence early in patients with early-stage breast cancer. 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. Breast cancer is the most common cancer in women in the U.S. and the second leading cause of cancer death in women.

The current standard of care for most patients with early-stage breast cancer consists of surgery and adjuvant chemotherapy and/or endocrine therapy. However, patients with early-stage breast cancer experience a rate of local recurrence of roughly 15% and distant metastases of 21% after primary treatment. Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer.

Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer and muscle invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 60 peer-reviewed papers.