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

Updated analysis shows 75% detection of recurrence with just one blood draw 4 weeks after surgery

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

CIRCULATE-Japan is the largest molecular residual disease (MRD)-guided clinical trial with over 3,300 patients with stage I-IV colorectal cancer (CRC) enrolled to date. This interim analysis at SSO, similar to the one previously presented at ASCO GI Symposium 2022analyzed the 6- and 12-month outcomes of 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 .

The latest results exclusive to SSO 2022 demonstrate 75% (45/60) detection of recurrence in stage II-III patients with a single blood draw 4 weeks after surgery. The previous ASCO GI analysis, which showed a one-time sensitivity of 68% (46/68), did not exclude non-cancer or treatment-related deaths. Previous studies have shown that serial surveillance further increases the recurrence detection rate by up to 88-93%.1.2

“Learnings from our study consistently suggest that stratification of post-surgical treatment decisions using Signatera can identify patients likely to benefit from adjuvant chemotherapy across the stages,” said the lead researcher of the study, Dr. Takayuki Yoshinofrom the National Cancer Center Hospital East, Kashiwa, Chiba, Japan. “We look forward to continuing to expand the study.”

The SSO presentation also indicates the growing interest and adoption of Signatera among cancer surgeons, who are finding utility in personalized monitoring and MRD assessment to inform surgical decisions. Signera has been shown in several studies3.4 be predictive of response to treatment in the neoadjuvant setting (before surgery) as well as in the adjuvant setting (after surgery), for several types of cancer.

In addition to presenting the latest data from the CIRCULATE-Japan study, Natera also announced the activation of CIRCULATE US trial, a nationwide, prospective, multicenter, 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), recently obtained an Investigational Device Exemption (IDE) from the FDA after extensive review of Natera’s clinical and analytical validation data. .

“Natera is committed to continuing to improve the sensitivity of MRD tests and improving outcomes for patients with CRC by performing definitive, prospective, practice-changing studies,” said Dr. Adham Jurdi, Medical Director of Oncology at Natera. “We are thrilled to be at the forefront of research in MRD and colorectal cancer and excited to see these landmark studies, like CIRCULATE-US, progress.

About Signera

Signatera is a custom-designed circulating tumor DNA (ctDNA) test for treatment monitoring and evaluation of molecular residual disease (MRD) in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has received three breakthrough device designations from the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor informed, providing each individual with a personalized blood test tailored to the unique signature of clonal mutations found in that individual’s tumor. This maximizes Signatera’s accuracy in 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 the amount of cancer remaining in the body, identify recurrences earlier and optimize treatment decisions.

About Natera

Natera™ is a global leader in cell-free DNA testing, dedicated to oncology, women’s health and organ health. Our goal is to integrate personalized genetic testing and diagnostics into the standard of care to protect health and inform earlier, more targeted interventions that help lead longer, healthier lives. Natera’s tests are validated by over 100 peer-reviewed publications that demonstrate high accuracy. Natera operates laboratories that are ISO 13485 certified and CAP accredited under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, TX 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 do not constitute 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 any 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, than the results of clinical studies or others support the use of our product offerings, the impact of the results of such studies, our expectations regarding the reliability, accuracy, and performance of our tests, or the benefits of our tests and product offerings to patients, providers and payers Additional risks and uncertainties are discussed in more detail under “Risk Factors” in Natera’s recent filings on Forms 10-K and 10-Q and in other filings by Natera with the SEC sometimes. These documents are available at investor.natera.com and www.sec.gov.

contacts

Investor Relations: Mike BrophyChief Financial Officer, Natera, Inc., 510-826-2350
Media: Kate StabrawaCommunications, Natera, Inc., [email protected]

The references

  1. Reinert T, Henriksen TV, Christensen E, et al. Analysis of plasma cell-free DNA by ultra-deep sequencing in patients with stage 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 relapses and monitoring of therapeutic efficacy by ultra-deep DNA sequencing without plasma cells in patients with urothelial carcinoma of the bladder. J Clin Oncol. 2019; 37(18):1547-1557.
  4. Magbanua MJM, Swigart LB, Wu HT, et al. Circulating tumor DNA in neoadjuvant-treated breast cancer reflects response and survival. Ann. Oncol. 2020;32(2):229-239.

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