At the 2026 ASCO Gastrointestinal Cancers Symposium, Natera presented updated, post-hoc blinded central radiographic review data from its randomized, double-blind Phase III ALTAIR trial (NCT04457297). The trial evaluated treatment on molecular recurrence with Trifluridine/Tipiracil (FTD/TPI) versus placebo in Signatera-positive patients across stage I–IV colorectal cancer. The new 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 (hazard ratio 0.75; 95% CI: 0.55–0.98; P=0.0406). These results mark the first time the full study population has reached statistical significance, representing a meaningful improvement over the initial ALTAIR findings, which showed only a numerical DFS advantage.

In a large-scale study presented alongside ALTAIR data, Natera demonstrated that colorectal cancer patients whose circulating tumor DNA (ctDNA) levels doubled within one month experienced roughly 40% shorter recurrence-free survival compared with those exhibiting slower doubling times. This prognostic association persisted regardless of adjuvant chemotherapy status and was measured using Natera’s mean tumor molecules (MTM) per mL plasma quantification. These findings support ctDNA velocity as a robust stratification tool for tailoring surveillance intensity and therapeutic interventions.

Natera launched its 21-gene Fetal Focus single-gene non-invasive prenatal test (sgNIPT), leveraging ultra-sensitive LinkedSNP™ technology, following blinded prospective validation in the EXPAND trial (NCT06808880). In 193 newly tested samples covering 16 additional genes, the assay achieved 100% sensitivity (14/14 affected pregnancies) and 94.2% specificity. Combined with prior data, the full 21-gene panel demonstrated 96% sensitivity (24/25 affected pregnancies) and 98% population-weighted specificity across 294 samples. These results represent the first prospective confirmation of an expanded single-gene NIPT panel with diagnostic confirmation for all outcomes.

These developments strengthen Natera’s leadership in precision oncology and women’s health. The ALTAIR trial’s statistical significance enhances the commercial and regulatory profile of Signatera-guided TOMR approaches, potentially accelerating adoption in colorectal cancer management. The expanded Fetal Focus sgNIPT addresses a sizable unmet need in prenatal screening when partner testing is unavailable, supported by rigorous prospective data. Together, these milestones support Natera’s growth trajectory, reinforce its evidence base of over 325 peer-reviewed publications, and leverage its ISO and CAP-accredited laboratory network to drive broader clinical adoption.