AUSTIN, Texas, August 4, 2021 / PRNewswire / – Natera, Inc. (NASDAQ: NTRA), a pioneer and world leader in cell-free DNA testing, announced that the first patient has been screened in a new Phase III trial that uses its personalized molecular residual disease (MRD) test, Signatera, to to identify patients with early-stage breast cancer eligible for investigational treatment with niraparib, a PARP inhibitor from GSK (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 after surgery or upon completion of adjuvant therapy in 800 patients with triple negative or HR-positive / HER2-negative breast cancer, BRCA-mutation breast cancer. After definitive initial treatment, serial testing with Signatera will be used to identify patients with detectable MRD to assess treatment with niraparib versus placebo in a setting where relapse is detected early before the radiologically defined progression of the disease. disease.
“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 patients with early-stage breast cancer will be monitored regularly using Signatera, with access to effective treatment upon detection of molecular recurrence.”
This is the second Phase III registration trial to integrate Signatera as a companion diagnostic. Signatera has been named a breakthrough device by the FDA for three different clinical indications, including a designation for the intended use of early-stage breast cancer currently being evaluated in the ZEST trial.
Signature is a custom-designed circulating tumor DNA (ctDNA) test for treatment monitoring and evaluation of residual molecular disease (MRD) in previously diagnosed cancer patients. The test is available for both clinical and research use, and has received three breakthrough device designations by the FDA for several types and indications of cancer. The Signatera test is personalized and informed about the tumor, providing each individual with a personalized blood test tailored to the unique signature of the clonal mutations found in that individual’s tumor. This maximizes the accuracy of Signatera in detecting the presence or absence of residual disease in a blood sample, even at levels up to a single tumor molecule in a blood tube. Signatera is intended to detect and quantify the amount of cancer remaining in the body, to detect recurrences earlier, and to help optimize treatment decisions.
The performance of the Signatera test has been clinically validated in several types of cancer, including colorectal, non-small cell lung, breast and bladder cancers. Signatera was developed and its performance characteristics determined by Natera, the CLIA certified laboratory performing the test. The test has not been authorized or approved by the United States Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified and CLIA certified.
Natera is a pioneer and world leader in cell-free DNA tests from a simple blood test. The company’s mission is to change the management of disease around the world with a focus on women’s health, oncology and organ health. Natera operates ISO 13485 certified and CAP accredited laboratories certified according to the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, California and Austin, Texas. It offers exclusive genetic testing services to educate obstetricians, transplant physicians, oncologists and cancer researchers, including biopharmaceutical companies and genetics labs through its cloud-based software platform. For more information visit natera.com. Follow Natera on LinkedIn.
All statements other than statements of historical fact contained in this press release are forward-looking statements and do not constitute a representation that Natera’s plans, estimates or expectations will be realized. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update any 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 market new product offerings, our ability to successfully increase demand, and revenue for our product offerings, whether the results of clinical or other studies will support the use of our product offerings, our expectations for the reliability, accuracy and performance of our tests, or the benefits of our tests and product offerings for patients, providers and payers. Additional risks and uncertainties are discussed in more detail in the âRisk Factorsâ section in recent documents filed by Natera on Forms 10-K and 10-Q and in other documents that Natera submits from time to time to the DRY. These documents are available on www.natera.com/investisseurs and www.sec.gov.
Investor Relations: Mike brophy, CFO, Natera, Inc., 650-249-9090
Media: Kate Stabrawa, Communications, Natera, Inc., 720-318-4080 [emailÂ protected]
SOURCE Natera, Inc.