At the 2026 ASCO Gastrointestinal Cancers Symposium, Natera presented a post-hoc blinded central radiographic review from the randomized, double-blind, phase III ALTAIR trial (NCT04457297) evaluating Trifluridine/Tipiracil (FTD/TPI) versus placebo in Signatera-positive patients with stage I–IV colorectal cancer. The updated analysis reclassified a subset of cases and demonstrated a median disease-free survival (DFS) of 9.23 months for FTD/TPI versus 5.55 months for placebo, corresponding to a hazard ratio of 0.75 (95% CI: 0.55–0.98; P = 0.0406). This marks the first time the full study population has achieved statistical significance, improving on the original readout that showed a numerical but non-significant DFS gain. These data reinforce the potential of early intervention on molecular recurrence (TOMR) guided by ctDNA monitoring to extend remission duration in colorectal cancer.

Also at ASCO GI, Natera reported results from a large-scale observational study assessing the prognostic value of Signatera velocity—measured in mean tumor molecules per mL of plasma—on recurrence-free survival (RFS). Patients whose ctDNA levels doubled within one month experienced approximately 40% shorter RFS compared with those exhibiting slower doubling times. This association held true regardless of receipt of adjuvant chemotherapy, highlighting the robustness of ctDNA dynamics as a risk stratification tool. The study encompassed over 500 colorectal cancer patients across multiple centers and underlines Natera’s capacity to translate real-world molecular data into clinically actionable insights.

Natera introduced its expanded 21-gene Fetal Focus single-gene non-invasive prenatal test (sgNIPT), leveraging ultra-sensitive LinkedSNP™ technology. In the blinded prospective EXPAND trial, 193 new clinical samples for the 16 added genes achieved 100% sensitivity (14/14) and 94.2% observed specificity. Combined with prior data, the full 21-gene panel now shows 96% sensitivity (24/25 affected cases) and 98% population-weighted specificity across 294 samples. This marks the first prospective, blinded validation of an expanded sgNIPT panel with confirmatory diagnostic testing, enabling detection of severe or early-onset inherited conditions—such as Tay-Sachs, Gaucher and galactosemia—when paternal carrier status is unknown.