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Natera Selected for NHS-Funded TRACERx Study of Lung Cancer Heterogeneity Using Cell-Free Tumor DNA

SAN CARLOS, Calif., July 8, 2015 /PRNewswire/ -- Natera, Inc., a leader in non-invasive genetic testing and the analysis of circulating cell-free DNA, today announced a research collaboration with University College London (UCL) Cancer Institute, where the Institute will use Natera's proprietary technology to detect variations in cell-free circulating tumor DNA (ctDNA) in the TRACERx study (Tracking Cancer Evolution through Therapy). The study aims to understand how lung cancers mutate, adapt and become resistant to treatments.

TRACERx is a study of 840 patients with non-small cell lung cancer, funded mainly by Cancer Research UK, with additional funding from the Rosetrees Foundation and UCL. It aims to define the evolutionary paths of cancer by sampling and analyzing each tumor several times, both before and after surgery. Tumor sampling will include multiple biopsies of the tumor tissue, as well as liquid biopsy of ctDNA in blood, to measure tumor heterogeneity and its evolution over time.

Natera was selected for the study by the TRACERx investigators at UCL Cancer Institute and Leicester, because of its comparative performance to other technologies in preliminary studies. "Natera's technology will provide a unique view into the clonal and subclonal tumor variations that we wish to track for this study," said Professor Charles Swanton, M.D., Ph.D. and Professor Jacqui Shaw, lead researchers for the TRACERx study.

Natera's novel technology platform, called massively-multiplexed PCR (mmPCR), when combined with its proprietary statistical algorithms, allows for highly sensitive interrogation of point mutations and copy number variations (CNV) from cell-free DNA in blood. The mmPCR technology has been studied and proven in the context of non-invasive prenatal testing (NIPT) for Down syndrome and other common aneuploidies, where Natera is a worldwide leader.

"We are honored to be working with Professor Charles Swanton and Professor Jacqui Shaw in Leicester and University College of London, which have a track record of lung cancer studies in the U.K.," said Matthew Rabinowitz, Ph.D., CEO of Natera. "This collaboration fits perfectly with Natera's mission to transform how people diagnose and manage genetic disease, including lung cancer, which kills more people every year than any other form of cancer. We are pleased that Natera's technology was selected for this landmark study, and we believe it will provide a springboard for Natera's plans to develop and launch commercially available cfDNA-based diagnostics for cancer of the lung, breast and ovaries."

The TRACERx study is expected to enable Natera to demonstrate how its technology can be used to improve cancer patient care and treatment outcomes. Specifically, Natera seeks to learn how ctDNA monitoring recapitulates subclonal evolution in NSCLC (non-small cell lung cancer), how it relates to treatment response, and if it can identify recurrence sooner for more effective treatment.

The study, entitled "Tracking Genomic Cancer Evolution for Precision Medicine: The Lung TRACERx Study," is listed online at [NCT01888601].

About Natera

Natera is a genetic testing company that develops and commercializes non-invasive methods for analyzing DNA. The mission of the company is to transform the diagnosis and management of genetic disease. In pursuit of that mission, Natera operates a CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, CA, and it currently offers a host of proprietary genetic testing services primarily to OB/GYN physicians and fertility centers, as well as to genetic laboratories through its cloud-based Constellation™ software system. Tests include the Spectrum™ pre-implantation genetic test for embryo selection during IVF; the Anora™ miscarriage test to understand the genetic causes of a pregnancy loss; the Horizon™ carrier screen to detect inherited mutations; and the Panorama™ non-invasive prenatal test (NIPT) to screen for common chromosomal anomalies in a fetus as early as nine weeks of gestation. Natera is also applying its unique technologies to develop non-invasive screening and diagnostic tools for earlier detection and improved treatment of cancer. These tests have not been cleared or approved by the U.S. Food and Drug Administration.

Forward-looking statements

This release contains forward-looking statements, including statements regarding the TRACERx Study and Natera's plans to develop and launch commercially available diagnostics and monitoring technology for cancer. Any forward-looking statements contained in this press release are based upon Natera's historical performance and its current plans, estimates, and expectations, and are not a representation that such plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press announcement. Subsequent events may cause these expectations to change, and Natera disclaims any obligation to update the forward-looking statements in the future. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including uncertainty in the development and commercialization of our planned future cancer products or other new products or if the results of our clinical studies do not support the use of our tests, or cannot be replicated in later studies required for regulatory approvals or clearances. Additional risks and uncertainties that could affect Natera's financial results are included under the captions, "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the company's final prospectus dated July 1, 2015. This is available on the company's website at under the Investors section and on the SEC's website at Further information on potential risks that could affect actual results will be included in other filings Natera makes with the SEC from time to time.

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