Natera announced the publication of two new peer‑reviewed studies that demonstrate the clinical utility of its Signatera tumor‑informed circulating tumor DNA (ctDNA) assay in anal squamous cell carcinoma (ASCC) and locally advanced rectal cancer (LARC). The findings were released on March 16 2026 and are expected to strengthen the assay’s clinical credibility and support broader adoption among oncologists and payers.
The ASCC study, published in Nature Communications, evaluated 84 patients and showed that serial Signatera testing can serve as a dynamic, treatment‑responsive biomarker. Patients who remained Signatera‑negative had 100 % one‑year overall survival (OS) and progression‑free survival (PFS), and 0 % one‑year local‑regional failure. In contrast, Signatera‑positive patients had 63 % OS, 44 % PFS, and 39 % locoregional failure at one year. Importantly, Signatera‑positivity preceded clinical or radiographic recurrence in every case where recurrence occurred.
The LARC study, reported in Cancers, evaluated 220 patients and confirmed that Signatera can detect minimal residual disease (MRD) and guide post‑treatment management. The assay identified patients at high risk of relapse who would benefit from additional surgical intervention. Signatera‑positive patients who did not receive neoadjuvant therapy had a 4.6‑fold higher risk of regrowth requiring surgery, while post‑operative Signatera negativity was associated with excellent clinical outcomes.
These studies reinforce Signatera’s position as a precision oncology tool and provide additional evidence that may support future Medicare coverage expansions. By demonstrating early detection of recurrence and informing therapeutic decisions, the data strengthen payer confidence and position Signatera as a potential standard of care in multiple solid‑tumor indications.
Natera’s Q4 2025 results, released on February 26 2026, showed revenue of $665.5 million, up 39.8 % YoY, and a gross margin of 66.9 %, an increase from 62.9 % in the prior year. Full‑year 2025 revenue reached $2.306 billion, up 35.9 %, with a gross margin of 64.7 % versus 60.3 % in 2024. The company guided 2026 revenue to $2.62 billion–$2.70 billion and gross margin to 63 %–65 %, reflecting strong demand for Signatera and confidence in continued growth.
Natera’s leadership highlighted that the new data further validates the company’s tumor‑informed approach and underscores the potential for Signatera to become a standard of care in multiple solid‑tumor indications.
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