Collaboration with Imperial College London and University of Leicester to Leverage Signatera™ (RUO) Personalized ctDNA Technology

SAN CARLOS, California, Nov. 1, 2017 /PRNewswire/ -- Natera, Inc., (NASDAQ: NTRA), a global leader in cell-free DNA testing, has entered into a research collaboration with Imperial College London and the University of Leicester, U.K., to leverage the company's Signatera™ (RUO) personalized circulating tumor DNA (ctDNA) technology to evaluate retrospectively the use of ctDNA to detect disease recurrence in women breast cancer patients. Signatera™ (RUO) was recently launched for use by oncology researchers and biopharmaceutical companies, and is expected to be available for clinical use next year.

Natera will partner with Cancer Research UK-funded researchers to help identify the optimal biomarkers for prediction of disease progression in women with breast cancer after their surgery and adjuvant therapy. The study is being led by Principal Investigators Dr. Charles Coombes, Professor of Medical Oncology, Imperial College London and Director of The Imperial CRUK Cancer Centre, and Dr. Jacqui Shaw, Professor of Translational Cancer Genetics at the University of Leicester Cancer Research Centre.

"We believe circulating tumor DNA may provide a meaningful guide to predict disease progression before scans for patients with breast cancer," Prof. Shaw said. "We are pleased to partner with Natera to explore this exciting new biomarker."

Breast cancer is the second leading cause of cancer death in women.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 is an ongoing problem, with 5 year recurrence rates estimated to be as high as 33% .^2,3

The collaborators will evaluate ctDNA levels in breast cancer patients who have completed chemotherapy and are at risk for disease recurrence. Patients were monitored with blood tests and physical exams for up to four years. The primary objective of the study is to determine the sensitivity, specificity, lead time, and utility of ctDNA analysis for the early detection of breast cancer recurrence. The study results are expected to read out in 2018.

"We look forward to working with Drs. Coombes and Shaw to characterize ctDNA as a potential biomarker for breast cancer progression," said Jimmy Lin, MD, PhD, MHS, Chief Scientific Officer, Oncology, at Natera. "They are experts in using ctDNA for disease monitoring in breast cancer. This is an excellent application of the Signatera™ technology."

Signatera™ (RUO) differs from currently available liquid biopsy technology, which tests for a generic panel of genes independent of an individual's tumor. It provides a customized blood test tailored to match the mutations found in each individual's tumor tissue, which maximizes sensitivity and specificity. Signatera™ also allows researchers to track up to several hundred additional mutations of interest for clinical studies. A recent study of patients with early stage non-small cell lung cancer (NSCLC) showed the value of Natera's customized ctDNA analysis for use in cancer research. The study, which was featured on the cover of the journal Nature, demonstrated the method's potential to detect residual disease, measure treatment response, and identify recurrence up to 11 months earlier than the standard of care.⁴

About Imperial College London
Imperial College London is one of the world's leading universities. The College's 16,000 students and 8,000 staff are expanding the frontiers of knowledge in science, medicine, engineering and business, and translating their discoveries into benefits for society. Founded in 1907, Imperial builds on a distinguished past—having pioneered penicillin, holography and fibre optics—to shape the future. Imperial researchers work across disciplines to improve health and wellbeing, understand the natural world, engineer novel solutions and lead the data revolution. This blend of academic excellence and its real-world application feeds into Imperial's exceptional learning environment, where students participate in research to push the limits of their degrees. Imperial collaborates widely to achieve greater impact. It works with the NHS to improve healthcare in West London, is a leading partner in research and education within the European Union, and is the UK's number one research collaborator with China. Imperial has nine London campuses. Learn more at www.imperial.ac.uk.   

About the University of Leicester
The University of Leicester is led by discovery and innovation—an international centre for excellence renowned for research, teaching, and broadening access to higher education. It is among the top 25 universities in the Times Higher Education REF Research Power rankings with, 75 percent of research adjudged to be internationally excellent with wide-ranging impacts on society, health, culture, and the environment. Learn more at https://le.ac.uk/about.

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.

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, 650-249-9091 x1471, mbrophy@natera.com

Media
Barbara Sullivan, Sullivan & Associates, 714-374–6174, bsullivan@sullivanpr.com

Reference

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

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SOURCE Natera, Inc.