Natera, Inc. announced robust results from a large-scale pan-cancer study of its Signatera Genome assay, presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The study analyzed the performance of Signatera Genome in a cohort of 392 patients, encompassing over 2,600 plasma samples across five different tumor types.
Key results demonstrated excellent pan-cancer performance, with Signatera Genome achieving an overall longitudinal sensitivity of 94% and a specificity of 100% across breast cancer, non-small cell lung cancer, melanoma, renal cell carcinoma, and colorectal cancer. The assay also showed ultra-sensitive detection, with nearly 50% of Signatera-positive cases detected in the ultra-sensitive range of 100 parts per million.
The study highlighted the assay's strong predictive power for long-term outcomes; Signatera-negative patients had an excellent prognosis, with 100% distant relapse-free survival (DRFS) at 12 months and 99% at 24 months. In contrast, Signatera-positive patients faced a significantly higher risk of recurrence, with DRFS dropping to 41% at 12 months and 14% at 24 months. Furthermore, Signatera Genome detected recurrence three months earlier, on average, compared to the Signatera Exome assay.
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