Natera Announces Clinical Findings on Signatera Publications
Natera announced two peer-reviewed publications highlighting the clinical utility of Signatera, its personalized, tumor-informed circulating tumor DNA assay, in anal squamous cell carcinoma and locally advanced rectal cancer. 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 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. 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 followed by non-operative management or surgery. 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, even among those with a complete or near-complete clinical response. Post-operative Signatera negativity was associated with excellent clinical outcomes. Signatera-negative patients experienced a relapse rate of 11.5% compared to 88.0% among Signatera-positive patients.
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- Study Publication: Natera announced that its Signatera study has been published in Clinical Cancer Research, marking the company's ongoing innovation and development in cancer detection.
- Clinical Impact: The publication of this study may enhance the application potential of Signatera in cancer monitoring, thereby strengthening Natera's market position in the biotechnology industry.
- Scientific Recognition: By being published in a reputable journal, Natera's research has gained recognition in the academic community, further validating the effectiveness and reliability of its technology.
- Future Outlook: The release of this study provides Natera with opportunities to expand its market, particularly in the fields of personalized medicine and cancer treatment monitoring.
- Clinical Study Findings: A prospective study published in Clinical Cancer Research reveals that 68% (23/34) of women over 70 tested MRD-negative with Signatera, and none of these patients experienced disease progression, highlighting Signatera's critical role in early breast cancer management.
- Optimized Treatment Choices: All participants in the study opted for primary endocrine therapy (pET) instead of surgery, indicating that Signatera can assist physicians in providing non-surgical treatment options for older patients, thus balancing disease control with quality of life considerations.
- Significant Monitoring Efficacy: Among the 11 patients who were MRD-positive at baseline, 64% (7/11) cleared their circulating tumor DNA (ctDNA) after 6 months, with all remaining free of distant progression, demonstrating Signatera's effectiveness in monitoring treatment response.
- Positive Patient Feedback: Over 80% of patients reported that Signatera informed their treatment decisions without increasing anxiety, further validating the tool's value in managing older breast cancer patients.
- ASCC Study Findings: A study involving 84 patients with anal squamous cell carcinoma revealed that Signatera testing correlates strongly with clinical outcomes, as patients who were ctDNA-negative at baseline had a 100% one-year overall survival rate, while ctDNA-positive patients had only 63%, highlighting Signatera's role in recurrence risk assessment.
- LARC Patient Selection: Research on 220 locally advanced rectal cancer patients demonstrated that Signatera can identify high-risk relapse patients, with Signatera-positive non-operative management patients being 4.6 times more likely to require surgical intervention, underscoring the importance of personalized treatment strategies.
- Clinical Outcome Comparison: Post-operative, Signatera-negative patients experienced an 11.5% relapse rate compared to 88.0% for positive patients, indicating the significant clinical value of Signatera testing in guiding surgical decisions and monitoring treatment responses.
- Personalized Monitoring Strategies: Natera's Chief Medical Officer stated that early detection of molecular residual disease through Signatera can support more individualized surveillance and treatment decisions, ultimately improving patient survival rates and quality of life.
Stock Sale Announcement: Officer Daniel Rabinowitz intends to sell 16,798 shares of its common stock on March 6, with a total market value of approximately $3.31 million.
Reduction in Shareholding: Daniel Rabinowitz has reduced his shareholding in Natera (NTRA.US) by 22,892 shares since January 20, 2026, with a total value of approximately $5.38 million.
- Significant Revenue Growth: In 2025, Exelixis reported a 7% revenue increase to $2.3 billion, primarily driven by its cabozantinib franchise, which not only solidifies its market position but also funds future research and development efforts.
- Improved Profitability: Earnings per share (EPS) reached $2.78, up 57.9%, reflecting the company's success in cost control and sales growth, which further boosts investor confidence in its financial health.
- New Drug Application Approval: The FDA approved the New Drug Application for zanzalintinib in combination with atezolizumab for metastatic colorectal cancer on February 2, with a final decision expected by December 3, potentially opening new revenue streams for the company.
- Expanded Partnerships: Exelixis has partnered with companies like Takeda and Ipsen to sell cabozantinib in Japan, while also collaborating with Natera for clinical trials of zanzalintinib, enhancing its market penetration and research capabilities.
- Drug Diversification: Exelixis' lead drug cabozantinib (Cabometyx and Cometriq) is approved for kidney, thyroid, and liver cancers, and is currently in a phase 3 trial for advanced neuroendocrine tumors in the lung, thymus, and gastrointestinal tract, which is expected to enhance its market share.
- New Drug Approval: The FDA approved zanzalintinib in combination with atezolizumab for metastatic colorectal cancer on February 2, with a final decision on its application due by December 3, which could significantly bolster Exelixis' product portfolio if successful.
- Strategic Partnerships: Exelixis collaborates with Takeda and Ipsen to sell cabozantinib in Japan, and has partnered with Natera to utilize its Signatera assay for identifying colorectal cancer patients, enhancing the efficacy of zanzalintinib's clinical trials.
- Strong Financial Performance: In 2025, Exelixis reported a 7% revenue increase to $2.3 billion, primarily from cabozantinib, with earnings per share (EPS) reaching $2.78, up 57.9%, reflecting the company's robust market performance and profitability.








