Natera, a prominent player in cell-free DNA and genetic testing, unveiled a significant breakthrough through its molecular residual disease (MRD) test, Signatera, showcased in a recent publication in JCO Precision Oncology. This study highlighted Signatera’s efficacy in early detection of recurrence among early-stage breast cancer patients. Examining 1,136 plasma samples from 156 patients over a span of up to 12 years post-surgery and chemotherapy, Signatera demonstrated its capability to identify relapse up to 38 months earlier than imaging techniques, with an impressive sensitivity rate of 88.2%.
Furthermore, the study revealed that patients testing positive for circulating tumor DNA (ctDNA) experienced notably worse relapse-free survival (RFS) and overall survival (OS), regardless of hormone receptor and HER2 subtype. Dr. Charles Coombes, the principal investigator, emphasized Signatera’s potential in facilitating early therapeutic interventions and clinical trials, thereby improving patient outcomes.
Given the high prevalence of breast cancer and its substantial recurrence rates post-primary treatment, the findings underscore the significance of early detection tools like Signatera. Dr. Minetta Liu, Natera’s chief medical officer of oncology, emphasized the potential of Signatera in enhancing care management for breast cancer patients and advocating for long-term monitoring, especially for high-risk individuals susceptible to late recurrences.
Signatera, characterized as a personalized, tumor-informed MRD test, utilizes circulating tumor DNA to precisely detect and quantify residual cancer, enabling timely intervention and treatment optimization. Notably, Signatera is already covered by Medicare for various cancer types, including colorectal, breast, ovarian, and muscle invasive bladder cancers, along with immunotherapy monitoring for any solid tumor.
Natera, as a global leader in genetic testing, aims to integrate personalized genetic diagnostics into the standard-of-care, enhancing health outcomes through informed interventions. Their tests, supported by extensive peer-reviewed evidence, are conducted in ISO 13485-certified and CAP-accredited laboratories, ensuring rigorous quality standards. With a commitment to advancing oncology, women’s health, and organ health, Natera continues to drive innovation in genetic testing and diagnostics to prolong and improve lives globally.