On July 7, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported data from a colorectal cancer (CRC) study of its tissue-free Latitude MRD assay, which were presented at the 2025 European Society for Medical Oncology GI Congress (ESMO GI) (Press release, Natera, JUL 7, 2025, View Source [SID1234654272]).
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The clinical performance of the assay was analyzed in a cohort of ~200 patients (>1,300 plasma samples) with resectable stage I-IV colorectal cancer. Samples were derived from the GALAXY arm of the CIRCULATE-Japan study, one of the largest and most comprehensive prospective studies of MRD testing in resectable CRC. Key results include:
Excellent clinical sensitivity to recurrence: The Latitude assay detected recurrence with 58% sensitivity in the post-surgical MRD window and 81% sensitivity in the surveillance setting, with median diagnostic lead time of 4.6 months.
High clinical specificity: In the surveillance setting, patient-level specificity was 92%, and sample-level specificity was 97%.
Highly prognostic of recurrence risk: MRD positivity was significantly associated with inferior outcomes during both the MRD (HR: 10, p<0.001) and surveillance (HR: 18, p<0.001) windows.
Highly predictive of adjuvant chemotherapy (ACT) benefit: Among high-risk stage II and stage III patients, those who were MRD-positive after surgery derived significant benefit from ACT (p<0.001), while no significant treatment benefit was observed in MRD-negative patients (p=0.54).
"This study demonstrates strong clinical potential for Natera’s tissue-free MRD assay," said Yoshiaki Nakamura, M.D., Ph.D., principal investigator of the study. "We clearly observed the prognostic and predictive value of the assay, seeing strong correlation of recurrence risk and adjuvant treatment outcomes."
"These results reinforce the data previously presented at ASCO (Free ASCO Whitepaper) GI, where our tissue-free Latitude MRD assay demonstrated high overall concordance to Signatera as well as strong standalone clinical performance," said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology at Natera. "When offered alongside Signatera, our tissue-free assay gives patients and providers the latitude to get a reliable MRD assessment even when tissue is unavailable."