Signatera assay to be used in research to evaluate treatment response and minimal residual disease

SAN CARLOS, California, June 19, 2018 /PRNewswire/ -- Natera, Inc., (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced a research collaboration with the Institut Jules Bordet, an internationally renowned multidisciplinary cancer reference center in Belgium, using the company's Signatera™ research-use-only (RUO) circulating tumor DNA (ctDNA) assay to evaluate molecular response and minimal residual disease (MRD) in women with early stage breast cancer.

Natera will analyze approximately 300 plasma specimens prospectively collected and banked from 80 patients diagnosed with non-metastatic breast cancer, who all received neoadjuvant chemotherapy followed by surgery, and who were then monitored for recurrence with serial imaging. The study will correlate results of the Signatera assay with clinical outcomes, including pathological response and event-free survival. With sample collection initiated in 2011, the study is led by Michail Ignatiadis, MD, PhD, attending physician in the Medical Oncology Department of Institut Jules Bordet and assistant professor at the Université Libre de Bruxelles.

"We are pleased to work with Natera to explore this exciting new approach for evaluating treatment response in the neoadjuvant setting," Dr. Ignatiadis said. "Detection and monitoring of circulating tumor DNA has great potential to improve patient care by assisting therapeutic decision-making both pre- and post-surgery."

This is the third breast cancer collaboration Natera has announced in the past 18 months. Breast cancer is the second leading cause of cancer death in women in the United States.¹ Approximately 250,000 women are diagnosed with invasive breast cancer every year in the United States.¹ While the overall survival rate for breast cancer has improved, recurrence remains an important clinical concern, with 5-year recurrence rates estimated to be as high as 33%.^2,3

"We look forward to working with Institut Jules Bordet on this study," said Jimmy Lin, MD, PhD, MHS, Natera's Chief Scientific Officer, Oncology. "We believe this collaboration may reveal new clinical indications for Signatera as a useful biomarker in breast cancer treatment and may pave the way for therapy response and minimal residual disease applications in other disease types."

About Signatera 
Signatera (RUO) is the first ctDNA assay custom-built for treatment monitoring and MRD assessment. The Signatera methodology differs from currently available liquid biopsy assays, which test for a panel of genes independent of an individual's tumor. Signatera provides each patient with a customized blood test tailored to match the mutations found in that individual's tumor tissue, which maximizes sensitivity and specificity. Signatera (RUO) also allows researchers to track additional mutations of interest, up to several hundred mutations, for clinical studies.

In a recent study, the Signatera (RUO) customized ctDNA assay demonstrated the method's ability to detect residual disease, measure treatment response, and identify recurrence up to 11 months earlier than the standard of care for early stage non-small cell lung cancer (NSCLC).⁴ Additional research presented at the 2018 American Association for Cancer Research meeting showed successful results from bladder and colorectal cancer studies, including median detection points of ctDNA that were 4.3 and 7.9 months ahead of clinical relapse detection, respectively.^5,6

About Institut Jules Bordet
Institut Jules Bordet is an autonomous hospital devoted entirely to patients suffering from cancerous diseases. For more than 75 years, Institut Jules Bordet has been offering its patients diagnostic and therapeutic strategies at the leading edge of progress to prevent, detect, and actively fight cancer. The institute pursues three missions: care, research, and teaching. Its international reputation attracts the world's finest experts in the field while its spirit of innovation has enabled it to participate in the development and discovery of new methods of diagnosis and treatment, with the aim of bringing them to the patient as rapidly as possible. For more information, visit www.bordet.be.

About Natera
Natera is a global leader in cell-free DNA testing. The mission of the company is to transform the diagnosis and management of genetic diseases. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif. It offers a host of proprietary genetic testing services to inform physicians who care for pregnant women, researchers in cancer including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. Follow Natera on LinkedIn and Twitter.

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, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our screening tests, or of the benefits of our screening 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.

Contacts
Investor Relations: Mike Brophy, CFO, Natera, 650-249-9090
Media: Barbara Sullivan, Sullivan & Associates, 714-374–6174, bsullivan@sullivanpr.com

References

1. American Cancer Society. About Breast Cancer, 2017. https://www.cancer.org/cancer/breast-cancer/about/how-common-is-breast-cancer.html. Accessed Oct. 27, 2017.
2. Brewster AM, Hortobagyi GN, Broglio KR, et al. Residual risk of breast cancer recurrence 5 years after adjuvant therapy. J Natl Cancer Inst 2008; 100:1179.
3. Dent R, Trudeau M, Pritchard K, et al. Triple-negative breast cancer: clinical features and patterns of recurrence. Clin Cancer Res 2007; 13: 4429-4434.
4. Abbosh C. et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature 545, 446–451 (2017) http://doi.org/10.1038/nature22364.
5. Birkenkamp-Demtröder K, et al. Sequencing of plasma cfDNA from patients with locally advanced bladder cancer for surveillance and therapeutic efficacy monitoring [abstract]. In: Proceedings of the annual meeting of the American Association for Cancer Research; 2018 April 14-18; Chicago; AACR; 2018. Abstract 3653.
6. Andersen C, et al. Personalized circulating tumor DNA analysis to monitor colorectal cancer [abstract]. In: Proceedings of the annual meeting of the American Association for Cancer Research; 2018 April 14-18; Chicago; AACR; 2018. Abstract 1590.

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