Natera, Inc. and MEDSIR (Medica Scientia Innovation Research) have entered into a partnership to launch the MiRaDoR (NCT05708235) phase II clinical trial focused on hormone‑receptor positive, HER2‑negative breast cancer. The study will enroll up to 60 patients who are Signatera‑positive and have no clinical or radiological evidence of recurrence, using serial circulating‑tumor DNA (ctDNA) levels as a predictive marker of treatment response.
The trial is structured around four treatment arms: Arm A delivers standard endocrine therapy; Arm B tests the selective estrogen receptor degrader Giredestrant; Arm C combines Giredestrant with the CDK4/6 inhibitor Abemaciclib; and Arm D pairs Giredestrant with the PI3K inhibitor Inavolisib for patients harboring PIK3CA mutations. The primary endpoint is the proportion of patients achieving a 90 % reduction or clearance of baseline ctDNA after three months of therapy, a stringent measure that could identify the most effective therapeutic combinations early in the disease course.
By extending its Signatera genome‑guided platform into this new therapeutic setting, Natera aims to demonstrate that ctDNA dynamics can guide personalized treatment decisions beyond standard endocrine therapy. The trial’s success could support future regulatory submissions and broaden the commercial reach of Signatera in breast cancer care, positioning the company to capture additional market share in the rapidly expanding precision‑oncology space, which is projected to exceed USD 260.5 billion by 2033 with breast cancer as a dominant segment.
Natera’s Q3 2025 results underscore the commercial momentum behind the Signatera platform. Total revenue rose 34.7 % YoY to $592.2 million, while gross margin expanded to 64.9 % from 61.8 % in Q3 2024. Net loss widened to $87.5 million, reflecting continued investment in research and development. Management raised 2025 revenue guidance to $2.18 billion–$2.26 billion, citing strong demand for MRD testing and the growing pipeline of clinical trials. CEO Steve Chapman highlighted the quarter as “excellent” and noted the largest increase in quarterly clinical MRD units to date.
Enrollment for MiRaDoR is underway, with active sites in the United Kingdom and additional European sites slated to open in 2026. The trial is funded by F. Hoffman‑La Roche Ltd. and sponsored by MEDSIR, which brings a decade of experience designing and managing oncology trials. Breast cancer remains the most common cancer in women worldwide, with approximately 2.3 million new cases in 2022, and HR+/HER2‑negative disease accounts for roughly 70 % of all breast cancer cases. The partnership leverages this high‑prevalence patient population to validate ctDNA as a real‑time biomarker for early‑stage disease.
The collaboration represents a strategic milestone for Natera, reinforcing its position as a leader in cell‑free DNA testing across women's health, oncology, and organ health. By demonstrating the clinical utility of Signatera in a therapeutic setting, Natera could accelerate its pipeline, enhance its competitive advantage, and open new revenue streams in precision oncology.
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