SAN CARLOS, Calif., Feb. 9, 2016 /PRNewswire/ — Natera, Inc., (NTRA), a leader in non-invasive genetic testing and the analysis of circulating cell-free DNA, today announced that Genetica, a leading laboratory for prenatal diagnostics in Switzerland, is now performing the Panorama non-invasive prenatal test (NIPT) at its genetics laboratory in Switzerland. Genetica is leveraging Natera’s proprietary technology via Constellation, Natera’s cloud-based software platform for clinical genomic analysis.
Panorama is a safe and simple way for expectant mothers to gain certain information about the health of their fetus without an invasive diagnostic procedure. Panorama uses a simple blood draw from the mother to examine cell-free DNA originating from both mother and fetus in maternal blood to screen for chromosome abnormalities, including trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome), trisomy 13 (Patau syndrome), monosomy X (Turner syndrome), and triploidy. The screening test can be performed as early as nine weeks of gestation and there is no risk to the fetus.
The Constellation software platform provides cloud-based access to the bioinformatic algorithms that Natera has developed for clinical genomic applications in circulating cell-free DNA. The availability of these algorithms allows partner laboratories around the world to rapidly develop and validate their own clinical genomic assays for current applications such as NIPT and non-invasive prenatal paternity testing and future products in development such as liquid biopsy assays for oncology. The Constellation software platform is developed to meet rigorous patient privacy standards and is highly scalable to accommodate the growing demand for genetic testing around the world.
Statutory health payers in Switzerland are now covering NIPT for high risk patients with increased trisomy risk in first trimester screening, allowing for broader patient access and increased demand for best-in-class test options from labs operating in Switzerland. Panorama complies with all Swiss Federal Office of Health regulations.
"We are very pleased that Genetica has chosen the Natera Constellation platform to offer NIPT locally in Switzerland, and is the first Constellation customer to launch commercially in Europe," said Matthew Rabinowitz, Ph.D., CEO of Natera. "Panorama is a trusted name in prenatal screening, and this continues Natera’s deployment of a platform that supports laboratories worldwide as they develop their non-invasive DNA testing capabilities."
About Genetica AG
Genetica AG, a leading diagnostics lab in Switzerland, was founded in 1985 as a spin-off of the University of Zürich. Prenatal diagnostics has been a focus at Genetica since the company’s inception. Genetica AG offers a wide range of genetic diagnostics services to hospitals and physicians, as wells as genetic counseling services to patients.
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 screen to detect inherited mutations; and the Panorama™ non-invasive prenatal test (NIPT) to screen for common chromosomal anomalies in a fetus as early as nine weeks of gestation. 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 (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.
This release contains forward-looking statements. All statements other than statements of historical facts contained in this press release, including statements regarding the scalability of Natera’s Constellation platform, 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 uncertainty in the development and commercialization of Natera’s current or planned future products or if the results of its clinical studies do not support the use of its tests, or cannot be replicated in later studies required for regulatory approvals or clearances. 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, 2015. 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 under the Investor Relations section, and on the SEC’s website at www.sec.gov.
Mike Brophy, Investor Relations, 650-249-9091 x 1471
SOURCE Natera, Inc.