Natera announced updated results from the randomized, double-blind, phase III ALTAIR trial (NCT04457297), showing a median disease-free survival (DFS) of 9.23 months for patients treated with Trifluridine/Tipiracil (FTD/TPI) versus 5.55 months on placebo (hazard ratio: 0.75; 95% CI: 0.55–0.98; P=0.0406). This post-hoc blinded central radiographic review reclassified a subset of cases, converting a previously numerical DFS advantage into a statistically significant benefit across stage I–IV colorectal cancer patients who were Signatera-positive. These findings could strengthen Natera’s positioning in the adjuvant therapy segment by providing robust evidence that molecular recurrence monitoring paired with targeted therapy extends recurrence-free intervals, potentially driving increased adoption of its Signatera platform in clinical practice.

Natera launched its 21-gene Fetal Focus single-gene non-invasive prenatal test (sgNIPT), supported by blinded prospective data from the EXPAND trial. In 193 new clinical samples covering 16 additional genes, the test achieved 100% sensitivity (14/14 affected pregnancies) and 94.2% specificity. Combined with earlier results, Fetal Focus now shows 96% sensitivity (24/25) and 98% population-weighted specificity across 294 samples. By enabling detection of severe inherited conditions such as Tay-Sachs and Gaucher disease when partner testing is unavailable, the expanded panel addresses a critical unmet need. This launch broadens Natera’s women’s health portfolio, offering a scalable revenue stream underpinned by ultra-sensitive LinkedSNP™ technology and a growing evidence base from over 1,800 EXPAND participants.