On June 2, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported 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) (Free ASCO Whitepaper) Annual Meeting (Press release, Natera, JUN 2, 2025, View Source [SID1234653650]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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).
"These results highlight that our ultra-sensitive Signatera Genome assay not only enables detection of ctDNA at extremely low levels, but also provides powerful insights into patient prognosis and treatment response," said Alexey Aleshin, M.D., MBA, corporate chief medical officer and general manager of oncology at Natera. "This is one of the largest MRD studies of a genome tumor-informed MRD assay, and reinforces the excellent performance of Signatera across a wide range of solid tumors."
About Signatera
Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and has coverage by Medicare across a broad range of indications. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 100 peer-reviewed papers.