A validation study published using Natera’s methylation‑based Latitude assay showed that postsurgical ctDNA positivity strongly predicted recurrence in colorectal cancer, with a hazard ratio of 10.0 in the MRD window and high specificity in patients who did not receive adjuvant chemotherapy. Longitudinal sensitivity for relapse detection was reported at >84 percent with median lead time of 4.6 months to clinical relapse. Separately, Natera submitted its Signatera MRD assay to the FDA as a premarket approval (PMA) for use as a companion diagnostic to guide adjuvant immunotherapy decisions in muscle‑invasive bladder cancer. The company cited phase III IMvigor011 data supporting Signatera‑guided treatment benefit. Together the readout and the regulatory filing tighten Natera’s position in ctDNA‑guided oncology care and support broader MRD adoption in clinical decision‑making.