Natera announced that the results of its Signatera™ test from the phase III CALGB (Alliance)/SWOG 80702 study were published in JAMA Oncology on December 18 2025. The randomized trial enrolled 940 colorectal cancer patients who had undergone curative surgery and had post‑surgical plasma samples available for analysis.
The study found that Signatera detected minimal residual disease (MRD) in patients after surgery and that ctDNA positivity was associated with a higher risk of recurrence. Importantly, adding the anti‑inflammatory drug celecoxib to standard chemotherapy reduced recurrence and death by roughly 40% in Signatera‑positive patients, while no benefit was observed in Signatera‑negative patients.
These findings give clinicians a powerful tool to identify patients who would benefit from adjuvant therapy and to avoid overtreatment in those without detectable MRD. The robust, peer‑reviewed evidence strengthens Natera’s evidence portfolio, a critical factor for securing payer coverage and for future Medicare Molecular Diagnostics (MolDx) submissions.
In the same quarter, Natera reported total revenue of $592.2 million, up 34.7% year‑over‑year, with product revenue growing 35.3%. Gross margin improved to 64.9% from 61.8% a year earlier, while the company posted a net loss of $87.5 million versus $31.6 million in Q3 2024. Management raised 2025 revenue guidance to $2.18 billion–$2.26 billion, reflecting confidence in continued growth despite the net loss.
Dr. Adham Jurdi, Natera’s senior medical director of GI oncology, said the publication “marks another important milestone in colorectal cancer research, highlighting Signatera as a critical tool in disease management. It further demonstrates Signatera’s predictive utility in identifying, with great precision, patients with MRD who will likely benefit from celecoxib in addition to chemotherapy, regardless of their PIK3CA status.”
The study’s publication positions Signatera ahead of competitors in the personalized MRD space. With Medicare coverage already in place for colorectal, breast, ovarian, and bladder cancers, the evidence may accelerate adoption in colorectal cancer and support expansion into other solid‑tumor indications.
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