Natera Selected for Circulating Tumor DNA Study in Bladder Cancer

Denmark's Aarhus University to Use Signateratm ctDNA Technology in Longitudinal Study

SAN CARLOS, California and AARHUS, Denmark, Sept. 22, 2017 /PRNewswire/ -- Natera, Inc., (NASDAQ: NTRA), a global leader in cell-free DNA testing, has entered into a research collaboration with Denmark's Aarhus University to leverage the company's Signateratm (RUO) personalized liquid biopsy technology to evaluate circulating tumor DNA (ctDNA) as a useful biomarker in the diagnosis and treatment of bladder cancer. Signateratm was recently launched for research use only (RUO) for oncology researchers and biopharmaceutical companies, and is not for use in diagnostic procedures. It is expected to be available for clinical use next year.

The study will evaluate over 400 prospectively obtained plasma samples from patients who underwent treatment for bladder cancer, and whose blood was collected serially through chemotherapy and surgery. Sequencing data from each patient's tumor will be provided by Aarhus University and run through the Signateratm proprietary ctDNA bioinformatics pipeline, resulting in custom ctDNA assays being designed for each patient. Personalized ctDNA analysis will be performed at multiple time points per patient to correlate ctDNA levels with clinical outcomes.

"Aarhus University's significant expertise in bladder cancer research, as well as its extensive repository of longitudinal patient tumor and blood samples, make it an ideal partner," said Jimmy Lin, MD, PhD, MHS, Chief Science Officer, Oncology, at Natera. "We expect that this study, plus additional research efforts in other cancer types, will help us build toward clinically validating Signatera. If validated, Signatera could enable earlier diagnosis, more precise monitoring, better determination of prognosis, and individualized treatment of disease."

"We are pleased to collaborate with Natera on this important research project involving a challenging cancer with high recurrence and mortality rates," said Dr. Lars Dyrskjøt Andersen, Professor, Department of Clinical Medicine at Aarhus University. "We expect that this study will provide new insights that may help improve patient outcomes. We have a long track record in translational bladder cancer research, and we anticipate that this collaboration with Natera will significantly accelerate development of molecular diagnostic tests for this disease." 

Signateratm differs from currently available liquid biopsy tests, which test 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 an individual's tumor tissue, which maximizes sensitivity and specificity. Signateratm 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 Signatera'stm potential to detect residual disease, measure treatment response, and identify recurrence up to 11 months earlier than the standard of care.¹

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 more 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. 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 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, [email protected]

Media
Barbara Sullivan, Sullivan & Associates, 714-374?6174, [email protected]

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