Second Study with Denmark's Aarhus University to Leverage Signatera™ (RUO) Personalized ctDNA Technology 

SAN CARLOS, California, Nov. 6, 2017 /PRNewswire/ -- Natera, Inc., (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced a second research collaboration with Denmark's Aarhus University utilizing the company's Signatera™ (RUO) technology to evaluate ctDNA as a useful biomarker for detecting minimal residual disease, treatment response, and disease recurrence in colorectal cancer patients. The company previously announced that the university would be using the Signatera™ technology in a bladder cancer study.

This second study will evaluate 130 patients with stage I-III colorectal cancer previously treated with surgery and adjuvant chemotherapy, and then monitored longitudinally with blood samples drawn approximately every three months for up to 36 months. Sequencing data from each individual's tumor will be provided by Aarhus University and analyzed using the Signatera™ proprietary bioinformatics pipeline, resulting in custom ctDNA assays designed for each individual. The objective of the study is to determine the relationship between post-surgical ctDNA levels, minimal residual disease, disease relapse, and adjuvant therapeutic response. Study results are expected in 2018, which will help support the launch of Signatera in the clinical setting.

Colorectal cancer is the fourth most common cancer diagnosed in the United States and has the second highest mortality rate among all cancer types.¹ In 2017, more than 135,000 people will be diagnosed with colorectal cancer², with five-year prevalence of 385,000.³ Multiple studies have shown that early detection of disease relapse can help improve outcomes.⁴

"We are pleased to expand our research partnership with Natera to include this study of ctDNA in colorectal cancer," said Claus Lindbjerg Andersen, PhD, Professor, Department of Molecular Medicine at Aarhus University. "Better diagnostic tools in the adjuvant setting are needed, especially with the proven benefit of earlier detection and treatment of disease relapse. We expect that this study of circulating tumor DNA will provide new insights that may help improve patient outcomes."

"We look forward to working with Aarhus University on this important research project," said Jimmy Lin, MD, PhD, MHS, Chief Scientific Officer, Oncology, at Natera. "This study will help define whether personalized ctDNA analysis can improve diagnosis and management in early stage colorectal cancer."

Signatera™ (RUO) was recently launched for use by oncology researchers and biopharmaceutical companies, and is expected to be available for clinical use next year. The technology differs from currently available liquid biopsy assays, which test for a generic panel of genes independent of an individual's tumor. It 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.

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.⁵

About Aarhus University
Aarhus University is a prestigious research institution located in Aarhus, Denmark. Founded in 1928, it is Denmark's second oldest university and its largest, with 42,500 enrolled students, 11,500 staff members, and a budget of 840 million Euros. Aarhus University's ambition is to be a globally oriented university with a commitment to excellence in research and education, and a strong engagement with the development community. Owing to its size and impressive results as a research-intensive university, Aarhus has a strong reputation and influence across the entire spectrum of disciplines locally, nationally, and globally. For information, visit www.au.dk/en/.

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

References

1. American Cancer Society. Cancer Statistics Center, 2017. https://cancerstatisticscenter.cancer.org/#!/ Accessed Oct. 19, 2017
2. American Cancer Society. Key Statistics for Colorectal Cancer, 2017. https://www.cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html. Accessed Oct. 15, 2017
3. National Cancer Institute: Surveillance, Epidemiology, and End Results (SEER). Clinics in Colon and Rectal Surgery, 2017. https://seer.cancer.gov/. Accessed Nov. 5, 2017
4. Tie J, Wang Y, Tomasetti C, et al. Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with stage II colon cancer. Sci Transl Med. 2016;8 (346):1-11.
5. 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.