SAN CARLOS, Calif., Dec. 18, 2015 /PRNewswire/ — Natera, Inc., (NASDAQ: NTRA), a leader in non-invasive genetic testing and the analysis of circulating cell-free DNA, today announced that MedGenome, a leader in clinical genomic testing and a provider of genomic solutions for personalized healthcare in India, is now performing the Panorama non-invasive prenatal test (NIPT) at its genetics laboratory in Bangalore, leveraging Natera’s proprietary technology and Constellation, Natera’s cloud-based software platform, for clinical genomic analysis. MedGenome is the first provider to offer NIPT locally in India, and its laboratory is the only such facility to receive PC-PNDT (Pre-Conception Prenatal Diagnostic Techniques) certification.
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 found in maternal blood originating from both mother and fetus 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. In accordance with Indian law, Panorama will not be used to reveal the sex of 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.
"We are pleased that MedGenome has chosen the Natera Constellation platform to offer NIPT to the large and rapidly-growing market in India," said Matthew Rabinowitz, Ph.D., CEO of Natera. "Constellation is a highly scalable platform that is enabling non-invasive DNA testing capabilities to laboratories around the world."
MedGenome is a leading provider of genomics solutions for personalized healthcare, with its state-of-the-art next-generation sequencing lab in Bangalore, India, a R&D lab and office in San Francisco, US and offices across India. MedGenome offers clinical diagnostic tests to major hospitals and clinics in India and partners with global players on genomics research and genome data analysis. Its proprietary cancer analytics platform, OncoMD, offers access to exhaustive curated content and built in analytics for cancer diagnostics and research. With a skilled workforce of close to 170 employees in India and the US, MedGenome aims to make a visible impact on healthcare through its genomic testing services, research focus and bioinformatics solutions. Its mission is to provide the most advanced clinical genomic solutions to Indian hospitals, clinicians and patients at an affordable cost and to offer advanced tools, analytics and databases to a global audience to interpret genomic data into meaningful information. For more information, visit www.medgenome.com.
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 Natera’s plans to implement its Constellation platform or to build or support it to scale, 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
Michael Hromadik, Media Relations, 858-442-2215
SOURCE Natera, Inc.