Study in Nature Shows Early Relapse Detection in Lung Cancer Using Natera's Technology for ctDNA Analysis

SAN CARLOS, Calif. and LONDON, April 26, 2017 /PRNewswire/ -- Natera, Inc., (NASDAQ: NTRA), a leader in non-invasive genetic testing, and Cancer Research UK, University College of London (UCL) Cancer Institute and the Francis Crick Institute today announced the publication of results from the first 100 patients in the Cancer Research UK-funded TRACERx study (Tracking Cancer Evolution Through Therapy [Rx]) by Nature. This is the first demonstration of using phylogenetic circulating tumor DNA (ctDNA) analysis to detect relapse and minimally residual disease in patients with early-stage non-small cell lung cancer (NSCLC). The study indicates that it is now feasible to use Natera's bespoke multiplex PCR technology to conduct clinical studies in NSCLC to identify and treat residual disease, define treatment response, and target emerging subclones prior to resistance. The manuscript, entitled "Phylogenetic circulating tumor DNA analysis depicts early stage lung cancer evolution", is available online on April 26, 2017 from Nature as an Accelerated Article Preview (AAP).¹

"We are pleased with the groundbreaking results of this two-year Cancer Research UK-funded collaboration with the TRACERx consortium, University College of London (UCL) Cancer Institute, and the Francis Crick Institute," said Natera CEO and founder, Matthew Rabinowitz, Ph.D. "We are working towards bringing this technology to market later this year, initially to serve researchers in academia and the pharmaceutical industry, and ultimately to save lives in the clinic by enabling earlier diagnosis and personalized treatment of disease."

TRACERx Study Highlights

In the TRACERx study, led by Principal Investigator Prof. Dr. Charles Swanton, bespoke personalized assays were developed by Natera to target variants selected after sequencing of primary tumors. Patients were followed after surgery with blood drawn every 3-6 months, and ctDNA measurements were used to track clonal and subclonal evolution of the disease. Natera's unique multiplexing capability allowed it to design and analyze over 20 PCR assays for each specimen, without splitting any plasma samples; this unique ability was critical for tracking multiple subclones simultaneously.

A subset of 24 patients were studied for detection of cancer relapse. Presence of circulating tumor DNA was successfully detected in 93% (13/14) of patients at or prior to relapse, up to 347 days earlier than standard of care. Test specificity was [90%] in a control group of 10 patients who remained relapse-free at the time of publication.

Results also showed the ability to predict treatment response in the adjuvant setting. For one patient in whom ctDNA levels were high just 48 hours after surgery, ctDNA shrank to zero after adjuvant chemotherapy and the patient remained disease-free at the time of publication. By contrast, for three patients in whom ctDNA levels remained high throughout adjuvant therapy, all three patients recurred within one year after surgery. This indicates the potential of phylogenetic ctDNA analysis to improve the benefits of adjuvant chemotherapy for NSCLC patients in the clinic by enabling earlier recurrence diagnosis and personalized treatment of disease.

"The next step is to pursue Phase III clinical studies, where therapeutic intervention can be started earlier based on diagnosis of molecular relapse in circulating tumor DNA, and where therapy can be directed to the evolving tumor subclone seeding metastatic recurrence," said Charles Swanton, M.D., Ph.D., of the Translational Cancer Therapeutics Laboratory at The Francis Crick Institute in London, and senior researcher and author of the study.

About TRACERx

The TRACERx (TRAcking Cancer Evolution through therapy (Rx)) lung study is a multi-million-pound research project taking place over nine years, aimed at transforming understanding of non-small cell lung cancer and taking a practical step towards an era of precision medicine. The goal of the study is to uncover mechanisms of cancer evolution by analyzing the intratumor heterogeneity in lung tumors from approximately 850 patients and tracking its evolutionary trajectory from diagnosis through to relapse. At £14 million, it's the biggest single investment in lung cancer research by Cancer Research UK, and the start of a strategic UK-wide focus on the disease, aimed at making real progress for patients. Led by Professor Charles Swanton at University College London (UCL), the study will bring together a network of experts from different disciplines to help integrate clinical and genomic data and identify patients who could benefit from trials of new, targeted treatments. Natera's technology was selected to provide unprecedented insight into the genomic landscape of primary and metastatic tumors and the impact of treatment upon this landscape. For more information, go to http://www.cruklungcentre.org/Research/TRACERx.

About Natera's Oncology Program

Natera's mPCR technology and proprietary algorithms for oncology applications were developed in the context of non-invasive prenatal testing (NIPT), which can identify Down syndrome and other chromosomal aneuploidies and microdeletions with high accuracy. Natera has enhanced this underlying technology for the oncology market, and believes that it has powerful tools for the early identification of cancer and for recurrence monitoring. The company plans to launch its first oncology testing services in late 2017 for research use only, based on the bespoke mPCR technology demonstrated in the TRACERx study.

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.

Product offerings 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 test to detect inherited mutations; the Panorama^® non-invasive prenatal test (NIPT) to identify common chromosomal anomalies in a fetus as early as nine weeks of gestation; and Evercord™, a cord blood and tissue banking service offered at birth to expectant parents. Each test described has been developed and its performance characteristics determined by the CLIA-certified laboratory performing the test.

These tests have not been cleared or approved by the U.S. Food and Drug Administration (FDA). Although FDA does not currently clear or approve laboratory-developed tests in the U.S., certification of the laboratory is required under CLIA to ensure the quality and validity of the tests. 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. All statements other than statements of historical facts contained in this press release are forward-looking statements. 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 release.

Subsequent events may cause these expectations to change, and Natera disclaims any obligation to update the forward-looking statements for any reason after the date of this press release.

These forward-looking statements are subject to a number of 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 the sections entitled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Natera's Form 10-K for the year ended December 31, 2016. 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. These documents are available for free on the company's website at www.natera.com in the Investor Relations section, and on the SEC's website at www.sec.gov.

¹Journal Reference: Abbosh, C., Birkbak, N, J., Wilson, G, A., et al. Phylogenetic ctDNA analysis depicts early stage lung cancer evolution. Nature. DOI: 10.1038/nature22364

Contacts: Natera, Inc.

Mike Brophy, Chief Financial Officer, 650-249-9091 x1471

mbrophy@natera.com

Laura Zobkiw, Corporate and Media Relations, 650-249-9091 x1649

Lzobkiw@natera.com

Contacts: Cancer Research UK

Kathryn Ingham, +44(0)2034695475, (outside-of-office-hours): +44(0)7050264059

Kathryn.ingham@cancer.org.uk

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SOURCE Natera, Inc.