Natera Announces Updated Signatera™ MRD Data from CIRCULATE-Japan Presented in Plenary Talk at the Society of Surgical Oncology Conference, and Activation of CIRCULATE-US Trial

Updated analysis shows 75% detection of recurrence with a single blood draw 4 weeks post surgery

AUSTIN, Texas, March 21, 2022 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced new Signatera data from the prospective, multi-center CIRCULATE-Japan trial, presented by Dr. Eiji Oki of Kyushu University in an oral presentation at the Society of Surgical Oncology (SSO) 2022 International Conference on Surgical Cancer Care.

CIRCULATE-Japan is the largest molecular residual disease (MRD)-guided clinical trial with more than 3,300 stage I-IV colorectal cancer (CRC) patients enrolled to date. This interim analysis at SSO, similar to the one previously presented at the 2022 ASCO GI symposium, analyzed 6-month and 12-month outcomes from 1,040 patients and showed that Signatera MRD-positive patients benefited significantly from adjuvant chemotherapy (ACT), while Signatera MRD-negative patients did not benefit from ACT.

Latest findings exclusive to SSO 2022 demonstrate 75% (45/60) detection of recurrence in stage II-III patients with a single blood draw at 4 weeks post surgery. The previous analysis from ASCO GI, which showed a single time point sensitivity of 68% (46/68), did not exclude non-cancer or treatment-related deaths. Prior studies have shown that serial monitoring further increases the detection rate of recurrence up to 88-93%.^1,2

"Learnings from our study consistently suggest that stratifying post-surgical treatment decisions using Signatera can identify patients likely to benefit from adjuvant chemotherapy across stages," said the study's Principal Investigator, Dr. Takayuki Yoshino, of the National Cancer Center Hospital East, Kashiwa, Chiba, Japan. "We look forward to continuing to expand the study." 

The presentation at SSO also indicates increasing interest in and adoption of Signatera among cancer surgeons, who are finding utility in personalized monitoring and MRD assessment to inform surgical decisions. Signatera has been shown in several studies^3,4 to be predictive of treatment response in the neoadjuvant setting (before surgery) as well as the adjuvant setting (after surgery), across multiple cancer types.

In addition to presenting the latest CIRCULATE-Japan study data, Natera also announced the activation of the CIRCULATE-US trial, a national, prospective, multi-center, randomized clinical trial to investigate MRD-guided treatment strategies for patients with early-stage CRC. The study, which is being conducted in partnership with NRG Oncology and funded by the National Cancer Institute (NCI), was recently granted an investigational device exemption (IDE) from the FDA after a thorough review of Natera's clinical and analytical validation data.

"Natera is dedicated to continuing to drive improvement in MRD test sensitivity and improving CRC patient outcomes by executing definitive, practice-changing prospective studies," said Dr. Adham Jurdi, medical director of oncology at Natera. "We're delighted to be at the forefront of MRD and colorectal cancer research and excited to see these landmark studies, like CIRCULATE-US, progress."

About Signatera

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual's tumor. This maximizes Signatera's accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Signatera is intended to detect and assess how much cancer is left in the body, to identify recurrence earlier and to help optimize treatment decisions.

About Natera

Natera™ is a global leader in cell-free DNA 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 validated by more than 100 peer-reviewed publications that demonstrate high accuracy. 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 our efforts to develop and commercialize new product offerings, 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 investor.natera.com and www.sec.gov.

Contacts

Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350
Media: Kate Stabrawa, Communications, Natera, Inc., [email protected]

References

1. Reinert T, Henriksen TV, Christensen E, et al. Analysis of plasma cell-free DNA by ultradeep sequencing in patients with stages I to III colorectal cancer. JAMA Oncol. 2019;5(8):1124–1131.
2. https://www.natera.com/company/news/new-results-from-the-landmark-prospective-circulate-trial-expand-clinical-utility-of-the-signatera-mrd-test-in-colorectal-cancer/
3. Christensen E, Birkenskamp-Demtroder K, Sethi H, et al. Early detection of metastatic relapse and monitoring of therapeutic efficacy by ultra-deep sequencing of plasma cell-free DNA in patients with urothelial bladder carcinoma. J Clin Oncol. 2019; 37(18):1547-1557.
4. Magbanua MJM, Swigart LB, Wu H-T, et al. Circulating tumor DNA in neoadjuvant-treated breast cancer reflects response and survival. Ann. Oncol. 2020;32(2):229-239.

SOURCE Natera, Inc.