Natera Presents Data at ESMO GI on its Tissue-Free Latitude™ MRD * Assay, Demonstrating Excellent Overall Performance in Colorectal Cancer
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 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.'
Notes
* MRD = Molecular residual disease
About Natera
Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women's health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera's tests are supported by more than 300 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. For more information, visit www.natera.com.
Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in 'Risk Factors' in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.
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