Natera announced on March 31, 2026 that a prospective study published in Clinical Cancer Research demonstrates its Signatera tumor‑informed circulating tumor DNA assay can identify older women with early‑stage ER+/HER2‑ breast cancer who can be safely managed with primary endocrine therapy (PET) without surgery.
The study enrolled 43 women aged over 70 with stage 1–3 ER+/HER2‑ disease. At baseline, 68% (23 of 34) were MRD‑negative by Signatera, and none of those patients experienced disease progression during follow‑up.
Among the 11 baseline MRD‑positive patients, 64% cleared ctDNA within six months of PET. All 7 of the MRD‑positive patients who cleared ctDNA remained free of distant progression, and one patient experienced locoregional progression that was detected by Signatera before imaging.
The data show 100% longitudinal sensitivity and negative predictive value, indicating that Signatera can reliably guide non‑surgical management and provide early detection of recurrence. The findings expand Signatera’s clinical utility beyond surveillance, potentially opening a new patient segment and strengthening its competitive moat in the precision oncology market.
"Treatment decisions for older patients with breast cancer often require balancing disease control with quality of life, other medical problems and patient preference," said Priscilla F. McAuliffe, M.D., Ph.D., lead author of the study and a surgical oncologist at the University of Pittsburgh. "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." Angel Rodriguez, M.D., senior medical director of oncology at Natera, added, "This study highlights the role of Signatera as a critical molecular monitoring tool for patients with breast cancer who defer surgery. By providing an early signal of disease progression that aligns with imaging, Signatera may help physicians monitor treatment response and make more informed care decisions for older patients.",
The announcement was positively received by the market, reflecting investor enthusiasm for a new application that could broaden Signatera’s patient base and drive future revenue growth. Natera’s strong recent financial performance—$665.5 million in revenue for Q4 2025, a 39.8% year‑over‑year increase, and a gross margin of 66.9%—provides a solid foundation for capitalizing on this expanded clinical utility. The company’s 2026 revenue guidance of $2.62 billion to $2.70 billion, with gross margins of 63% to 65%, underscores management’s confidence in continued growth as new indications for Signatera mature.
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