SAN CARLOS, Calif., Aug. 21, 2017 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a leader in non-invasive genetic testing, today announced the launch of SignateraTM, a circulating tumor DNA (ctDNA) technology that analyzes and tracks mutations specific to an individual's tumor, for research use only (RUO) by oncology researchers and biopharmaceutical companies.
Already in clinical validation with multiple world-leading cancer institutes, SignateraTM offers a novel personalized approach to cancer detection in plasma. The technology analyzes whole-exome sequencing data from a patient's tumor sample in order to custom design individual-specific assays, targeting 16 or more mutations known to be present in the tumor tissue ("tumor signatures"). This unique approach enables high sensitivity and specificity for ctDNA detection and monitoring.
"We are excited to make this breakthrough technology available for researchers in academia and the pharmaceutical industry," said Matthew Rabinowitz, Ph.D., Natera's chief executive officer. "We also look forward to this personalized, non-invasive approach potentially being used to save lives in the clinic by enabling earlier diagnosis, more precise monitoring, better determination of prognosis, and individualized treatment of disease."
SignateraTM differs from currently available liquid biopsy tests, which screen for a generic set of mutations independent of an individual's tumor. By targeting 16 or more patient-specific mutations, SignateraTM has a higher probability of detecting ctDNA targets in plasma, compared with a generic-panel approach. It detects variant allele frequencies (VAF) down to 0.01%—one mutant copy in a background of 10,000 genomic copies—and is optimized to achieve high specificity by requiring detection of multiple mutations for a ctDNA-positive call, leading to fewer false positives.1 Furthermore, SignateraTM provides researchers the flexibility to track additional mutations of interest, up to several hundred mutations, for clinical studies.
A recent study featured on the cover of the journal Nature demonstrated the value of Natera's personalized ctDNA analysis for use in cancer research. The study showed that an early version of SignateraTM identified 43% more ctDNA-positive early-stage lung cancer cases than a generic lung cancer panel and demonstrated its potential to detect residual disease, measure treatment response, and identify recurrence up to 11 months earlier than the standard of care.1
"Natera's novel and unique technology indicates that it can be well-suited for adaptive clinical studies focused on a wide variety of tumor types," said Laura van 't Veer, Ph.D., leader of the University of California San Francisco (UCSF) Breast Oncology Program and chair of the I-SPY 2 biomolecular committee. "Selecting Natera's personalized ctDNA technology as part of the I-SPY 2 TRIAL will improve our ability to determine the success of new agents or combinations, help us design additional targeted interventions, and accelerate the pace of making effective, targeted treatments available to the women who will benefit most.
Natera's multiplex PCR (mPCR) technology and proprietary algorithms for oncology applications were developed in the context of non-invasive prenatal testing (NIPT), which can identify chromosomal abnormalities with high accuracy. Natera has enhanced this underlying technology for the oncology market, achieving substantially better accuracy than competitive technologies, and believes that it has powerful tools for the early identification of cancer, recurrence monitoring, and therapy response monitoring.
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. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif. It offers a host of proprietary genetic testing services to inform physicians who manage pregnant women, researchers in cancer including biopharmaceutical companies, and genetic laboratories through its cloud-based Constellation™ software platform.
Product offerings include Spectrum®, a preimplantation genetic test for embryo selection during in vitro fertilization (IVF); Anora® to understand the genetic causes of a pregnancy loss; Horizon™ to detect risk of inherited mutations such as cystic fibrosis and spinal muscular atrophy; Panorama®, a non-invasive pregnancy test (NIPT) to screen for common chromosomal anomalies in a fetus as early as nine weeks of gestation; Vistara to screen for single-gene disorders that represent total incidence greater than Down syndrome; Evercord™, a cord blood and tissue banking service offered at birth to expectant parents; and SignateraTM, a personalized cell-free DNA test that can identify minimal residual disease, treatment response, and cancer recurrence to aid researchers in oncology.
Each test described above except SignateraTM has been developed and its performance characteristics determined by the CLIA-certified laboratory performing the test. Panorama® and Constellation™ are CE-marked for sale in the European Union. 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. SignateraTM is for research use only at this time.
Forward-looking statementsThis 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 on Natera's historical performance and its current plans, estimates, and expectations; they 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, and 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-Q for the quarter ended June 30, 2017. 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.
Investor relations: Mike Brophy, Natera, 650.249.9091 x1471, Mbrophy@natera.com
Media: Barbara Sullivan, Sullivan & Associates, 714.374.6174, email@example.com
1. Abbosh C. et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature 545, 446–451 (2017) http://doi.org/10.1038/nature22364
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