Natera Announces Participation In I-SPY 2 TRIAL For Breast Cancer

SAN CARLOS, Calif., Dec. 14, 2016 /PRNewswire/ -- Natera, Inc., (NASDAQ: NTRA), a leader in non-invasive genetic testing and the analysis of circulating cell-free DNA, today announced a collaboration with Dr. Laura van 't Veer  and Dr. Laura Esserman of UCSF and QuantumLeap Healthcare Collaborative to participate in the I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2), a multi-center study evaluating the safety and efficacy of investigational therapies combined with neoadjuvant treatment in women with newly diagnosed, locally advanced breast cancer. In this trial, Natera will be analyzing blood samples at various points throughout patient treatment to evaluate the effectiveness of liquid biopsy in monitoring tumor burden, treatment response, and residual disease, as compared to traditional imaging methods.

The I-SPY 2 TRIAL was launched in 2010 and has enrolled over 1,000 patients so far. Investigators have prospectively collected matched tissue and plasma samples over the course of patients' treatment. Short term (complete response to therapy) and long term (three years disease-free survival) outcomes are tracked. In the initial cohort, Natera will create personalized liquid biopsy assays for each patient based on their tumor and monitor each patient over time.

"We're pleased to include Natera as a strategic partner in this important trial; Natera's novel, early work in disease detection and progression of breast cancer will hopefully improve our ability to inform the success of new agent/combinations and help us to design additional targeted interventions to successfully treat each patient", said Laura Esserman, MD, MBA, Director of the Breast Care Center at UCSF Helen Diller Family Comprehensive Cancer Center and founder of the QuantumLeap Healthcare Collaborative.

"The I-SPY TRIAL is designed to accelerate the pace of finding the most effective, targeted treatments and to make them available to the women who will benefit most," said Laura van 't Veer, PhD, UCSF Breast Oncology Program Leader and I-SPY 2 Biomarker Chair.

"We are very pleased to be selected as the liquid biopsy partner in this trial," said Jimmy Lin MD, PhD, MHS, Chief Scientific Officer of Oncology at Natera. "I-SPY 2 is one of the preeminent clinical trials in oncology.

 It offers a large and very rare longitudinal patient population that will accelerate validation of our oncology products."

About QuantumLeap Healthcare Collaborative
The I-SPY 2 Trial is sponsored by QuantumLeap Healthcare Collaborative, a non-profit foundation that was established in 2005 as a collaboration between medical researchers at University of California at San Francisco, and Silicon Valley entrepreneurs. QuantumLeap's mission is to accelerate transfer of high-impact research in clinical processes and systems technology into widespread adoption so that patients and physicians can benefit from the research as soon as practicable. QuantumLeap provides operational, financial and regulatory oversight to I-SPY 2 and is also the sponsor of the I-SPY Phase 1 program and I-SPY 3, a companion phase 3 confirmatory trial that is in development.

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 test to detect inherited mutations; and the Panorama® non-invasive prenatal test to detect for common chromosomal anomalies in a fetus as early as nine weeks of gestation.

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 whether the results of our clinical studies will support the use of our tests, our ability to enroll additional patients in our studies, our ability to increase demand for our screening tests, our expectations of the reliability, accuracy and performance of our screening tests, or of the benefits of our screening tests 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-Q for the quarter ended September 30, 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 SEC's website at www.sec.gov.

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SOURCE Natera, Inc.