AUSTIN, Texas, Aug. 4, 2021 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, announced that the first patient has been screened in a new phase III trial that uses its personalized, tumor-informed molecular residual disease (MRD) test, Signatera, to identify early-stage breast cancer patients eligible for investigational treatment with GSK’s PARP inhibitor niraparib (ZEJULA).
The ZEST study, sponsored by GSK, is a randomized, multicenter, phase III, placebo-controlled clinical trial to evaluate the efficacy and safety of treatment with niraparib following surgery or completion of adjuvant therapy in 800 patients with either triple-negative breast cancer or HR-positive/HER2-negative, BRCA-mutated breast cancer. After definitive upfront treatment, serial testing with Signatera will be used to identify patients who have detectable MRD to evaluate therapy with niraparib versus placebo in a setting where relapse is detected early ahead of radiologically defined disease progression.
"We are delighted to partner with GSK, a leader in oncology drug development, to help bring personalized medicine to patients with early-stage breast cancer," said Solomon Moshkevich, general manager of oncology at Natera. "Our vision is that early-stage breast cancer patients will be monitored regularly using Signatera, with access to effective treatment upon the detection of molecular recurrence."
This is the second phase III registrational trial to incorporate Signatera as a companion diagnostic. Signatera has been designated as a Breakthrough Device by the FDA for three different clinical indications, including one designation for the early-stage breast cancer intended use being evaluated in the ZEST trial.
Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes Signatera’s accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Signatera is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions.
Signatera test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Signatera has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.
Natera is a pioneer and global leader in cell-free DNA testing from a simple blood draw. The mission of the company is to change the management of disease worldwide with a focus on women’s health, oncology, and organ health. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, California and Austin, Texas. It offers proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. Follow Natera on LinkedIn.
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 or other studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our 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.
Investor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090
Media: Kate Stabrawa, Communications, Natera, Inc., 720-318-4080 firstname.lastname@example.org
SOURCE Natera, Inc.