Two Publications Highlight Clinical Utility of Signatera™ in Anal and Rectal Cancers

New findings show that Signatera status can help identify high-risk patients and inform non-operative management and surveillance strategies

AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced two peer-reviewed publications highlighting the clinical utility of Signatera, its personalized, tumor-informed circulating tumor DNA (ctDNA) assay, in anal squamous cell carcinoma (ASCC) and locally advanced rectal cancer (LARC).

ASCC: publication in Nature Communications

A recently published study evaluated 84 patients with ASCC to assess whether serial Signatera testing may offer a dynamic, treatment-responsive biomarker to further stratify recurrence risk and inform surveillance and treatment. Key findings include:

• Signatera-status was strongly correlated with clinical outcomes. Patients who were Signatera-negative at baseline or cleared ctDNA during chemoradiotherapy (CRT) had favorable outcomes, including 100% one-year overall survival and progression-free survival, and 0% one-year local regional failure. Patients who remained ctDNA-positive after CRT had poorer outcomes (63% OS, 44% PFS, 39% locoregional failure at one year).
• In 100% of recurrent cases, Signatera-positivity preceded clinical and/or radiographic recurrence highlighting ctDNA’s potential as an early indicator of relapse.

LARC: publication in Cancers

Another recent study evaluated 220 patients with LARC treated with neoadjuvant therapy (NAT) followed by non-operative management (NOM) (n=72) or surgery (n=148). The study examined how Signatera status after NAT may inform patient selection for organ-preserving NOM versus surgery and guide intensified surveillance strategies. Key findings include:

• Signatera identified post-NAT patients at high risk of relapse requiring surgical intervention. Signatera-positive NOM patients were at 4.6x higher risk of regrowth requiring surgery (HR 4.62; p=0.003), even among those with a complete or near-complete clinical response.
• Post-operative Signatera negativity was associated with excellent clinical outcomes. Signatera-negative patients (HR:15, p=0.001) experienced a relapse rate of 11.5% compared to 88.0% among Signatera-positive patients (p