New Publication Validates Performance of Natera's Signatera™ MRD Test in Ovarian Cancer

Multi-site study shows personalized ctDNA analysis is highly prognostic of recurrence-free survival and outperforms CA-125 in identifying patients at high risk of recurrence

AUSTIN, Texas, Oct. 6, 2022 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced the publication of a manuscript in Gynecologic Oncology, found here, validating the performance of its personalized molecular residual disease (MRD) test, Signatera, in epithelial ovarian cancer (EOC). This study adds to the growing library of over 30 published clinical studies incorporating Signatera technology.

The blinded, multi-site study analyzed 163 plasma samples from 69 patients with Stage I-IV disease across a range of histologies, including high-grade serous (54%), endometrioid (13%), clear cell (13%) and other (20%). Test performance was evaluated at multiple time points: pre-surgery, post-surgery prior to adjuvant treatment, and longitudinally every 3 months for up to 40 months after the completion of definitive therapy. With longitudinal testing, recurrence was detected with 100% sensitivity, 100% specificity, and an average lead time of 10 months ahead of imaging compared to 1 month for CA-125.

"Ovarian cancer is an aggressive disease with poor survival, especially in advanced stages. This study suggests that ctDNA analysis can provide clinicians with invaluable information regarding an individual patient's prognosis," said Dr. Minetta C. Liu, Natera's chief medical officer of oncology. "Furthermore, high sensitivity and a significant lead time in detecting recurrence before both CA-125 and surveillance imaging could elicit a meaningful impact on patient outcomes by informing timely treatment decisions for personalized disease management."

EOC is the most lethal gynecologic cancer worldwide.¹ In the U.S., it is the fifth most common cancer type in women.² The 5-year survival rate decreases significantly as stage increases³ and the majority of patients will recur, even when achieving complete remission with primary treatment.⁴

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.

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.

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, or coverage and reimbursement determinations from third-party 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.

Contacts

Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-405-4709

Media: Brian Symmons, SVP of Marketing and Corporate Affairs, Natera, Inc., [email protected]

References

1. C.A. Doubeni, A.R. Doubeni, A.E. Myers, Diagnosis and management of ovarian cancer, Am. Fam. Physician 93 (11) (Jun 1, 2016) 937–944, [Online]. Available https://www.ncbi.nlm.nih.gov/pubmed/27281838.
2. R.L. Siegel, K.D. Miller, H.E. Fuchs, A. Jemal, Cancer statistics, 2022, CA Cancer J. Clin. 72 (1) (Jan 2022) 7–33, https://doi.org/10.3322/caac.21708.
3. National Comprehensive Cancer Network (NCCN), NCCN Clinical Practice Guidelines in Oncology: Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer Version 1.2022 [Online], Available: https://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf.
4. T. Damak, R. Chargui, J. Ben Hassouna, M. Hechiche, K. Rahal, "Results of second-look laparotomy in advanced ovarian cancer: one single center experience," (in eng), ISRN Obstet. Gynecol. 2012 (2012), 849518, https://doi.org/10.5402/2012/849518.

SOURCE Natera, Inc.

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