Natera Inc. has announced the publication of new findings from the I-SPY 2 clinical trial in Nature Communications, evaluating the use of its Signatera™ personalized circulating tumor DNA (ctDNA) test in early-stage, high-risk breast cancer. The study assessed 723 women receiving neoadjuvant therapy and measured ctDNA at four time points. Results showed that Signatera improved risk assessment for recurrence beyond standard residual cancer burden $(RCB)$ measures. Patients with a negative Signatera result after neoadjuvant therapy had significantly higher three-year distant recurrence-free survival rates compared to those with a positive result. Persistent ctDNA positivity was identified as a strong independent predictor of metastatic recurrence. The findings support the potential of Signatera as a biomarker for treatment response and recurrence risk in early-stage breast cancer. The results have already been published.
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