Overall pan-cancer sensitivity of 94% and specificity of 100%, with analytical detection down to 1 PPM

Natera, Inc. (NASDAQ:NTRA), a global leader in cell-free DNA and precision medicine, announced results from a large-scale pan-cancer study of its Signatera Genome assay, which was presented today, June 2nd, 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 (> 2,600 plasma samples) across five different tumor types (breast cancer, non-small cell lung cancer, melanoma, renal cell carcinoma, and colorectal cancer). Key results included:

• Excellent pan-cancer performance: Signatera Genome demonstrated overall longitudinal sensitivity of 94% and specificity of 100% across 5 cancer types. Longitudinal sensitivity was 100% in lung cancer and renal cancer, and post-surgical landmark sensitivity was over 70% in both lung cancer and breast cancer.
• Ultrasensitive detection: In the surveillance setting, nearly 50% of Signatera-positive cases were detected in the ultra-sensitive range (≤100 parts per million).
• Highly predictive of long-term outcomes: In the pancancer cohort, patients who tested Signatera-negative had excellent prognosis, with 100% distant relapse-free survival (DRFS) at 12 months and 99% at 24 months. In contrast, Signatera-positive patients faced a markedly higher risk of recurrence, with DRFS dropping to 41% at 12 months and just 14% at 24 months.
• Extended lead times: Signatera Genome detected recurrence 3 months earlier, on average, compared to the Signatera Exome assay.
• Demonstrates Signatera's potential to identify which patients may benefit from adjuvant therapy: Among Signatera-positive patients, those who received adjuvant therapy had significantly improved outcomes, with a 12-month DRFS of 83% compared to 49% for those who did not receive therapy. For Signatera-negative patients, there was no meaningful benefit from adjuvant therapy with a 12-month DRFS of 93% (treated) vs. 98% (observation).