Natera, Inc. (NTRA) has reported new clinical evidence showing that its Signatera molecular residual disease test may help identify certain older women with early breast cancer who can safely avoid surgery.
The findings, published in Clinical Cancer Research, suggest that Signatera could support a less invasive treatment approach for patients who choose primary endocrine therapy instead of an operation.
Breast cancer treatment in women over 70 often requires balancing disease control with quality of life, other medical conditions and patient preference. While primary endocrine therapy is an alternative to surgery for some patients with early breast cancer, physicians have lacked reliable tools to determine who can forgo surgery without increasing their risk.
The prospective study enrolled 43 women aged 70 and older with stage 1-3 ER+/HER2- breast cancer, all of whom elected to skip surgery and receive endocrine therapy alone. Patients were tested with Signatera before treatment and then every three to six months, alongside standard imaging and clinical assessments.
The results showed that 68% of patients were MRD-negative at baseline, and none of them experienced disease progression- a 100% negative predictive value. Among those who were MRD-positive at the start of treatment, 64% cleared their circulating tumor DNA after six months of therapy, and all remained free of distant progression. In every case where cancer progressed, Signatera detected MRD before imaging, demonstrating 100% longitudinal sensitivity.
More than 80% of participants reported that Signatera helped inform their treatment decisions without increased anxiety.
"The findings from this study suggest ctDNA monitoring with Signatera could help identify patients for whom non-surgical approaches for their breast cancer treatment may be appropriate," said Dr. Priscilla F. McAuliffe, lead author and surgical oncologist at the University of Pittsburgh. Angel Rodriguez senior medical director of oncology at Natera, added that the study highlights Signatera's role as a molecular monitoring tool for patients who defer surgery.
Natera describes Signatera as part of its broader precision-medicine portfolio, which spans oncology, women's health and organ health. ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates in Boulder, Colorado.
NTRA has traded between $125.38 and $256.36 over the past year. The stock closed Monday's trading at $186.84, up 2.29%. In the pre-market the stock is at $196.57, up 5.21%.
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