Natera Provides Constellation™ Update
Cloud-based software platform continues to fuel growth and expansion into international markets
SAN CARLOS, Calif., Dec. 21, 2016 /PRNewswire/ — Natera, Inc., (NASDAQ: NTRA), a leader in non-invasive genetic testing, today announced the availability of a microdeletions testing application for new and existing Constellation licensees worldwide. With the addition of the microdeletions testing capability, Constellation is rapidly becoming a popular delivery platform to access Natera’s innovative technologies, including its prenatal and paternity testing technologies. Natera has now made its technologies available through Constellation in 15 countries, with the first commercial launch by a licensed lab in late 2015.
Microdeletion Testing Expansion
Microdeletions are genetic mutations in which very small pieces of DNA are not visualized using routine chromosome analysis. Microdeletions carry equal risk to all pregnant women, regardless of maternal age, and are harder to detect than other chromosomal abnormalities. Globally, Natera’s Panorama is the only SNP-based NIPT that screens for 22q11.2 deletion syndrome, a common yet often undetected condition that can have short and long-term health implications.
"There is a growing demand for comprehensive genetic testing worldwide, and Constellation presents an opportunity to provide access to Natera’s advanced technology portfolio to more patients in a greater number of countries around the world," said Matthew Rabinowitz, Ph.D., CEO and Founder of Natera. "The addition of microdeletions screening provides an additional benefit to many of these labs who do not, or cannot test for these conditions, which – despite often going undetected – are common and can cause severe health issues for children. We are excited to offer industry leading sensitivity for conditions like 22q deletion, which is the most common microdeletion."
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. To date, Natera has signed more than 20 licensing agreements in various regions/countries around the world.
The Constellation software platform provides secure-hosted access to the bioinformatics algorithms that Natera has developed for clinical genomic applications in circulating cell-free DNA. The availability of these algorithms allows licensee 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.
Panorama, Natera’s non-invasive prenatal test, determines the chance that a pregnancy has certain chromosomal abnormalities. It involves a simple blood draw. Panorama is the only commercially available NIPT that analyzes single nucleotide polymorphisms (SNPs) to detect for chromosomal abnormalities, allowing it to distinguish between fetal (placental) and maternal cell-free DNA. The ability to determine the difference between maternal and fetal DNA results in higher specificities than other tests. Panorama also more accurately identifies the probability of genetic conditions, including common chromosomal abnormalities, than traditional Maternal Serum Screening (MSS). These include Trisomy 21(Down Syndrome), Trisomy 18 (Edwards Syndrome), Trisomy 13 (Patau Syndrome) and Triploidy; sex chromosome abnormalities, and five microdeletions, including 22q11.2 deletion syndrome.
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 test to detect inherited mutations; and the Panorama® non-invasive prenatal test (NIPT) to identify common chromosomal anomalies in a fetus as early as nine weeks of gestation.
Each test described has been developed and its performance characteristics determined by the CLIA-certified laboratory performing the test. 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.
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.
This 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 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 with respect to our ability to increase demand for our screening tests, our expectations of the reliability, accuracy and performance of our screening tests, or of the benefits of our screening tests to patients, providers and payers, or our ability to successfully implement, commercialize or scale our Constellation platform.
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, 2016. 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 SEC’s website at www.sec.gov.
Mike Brophy, SVP of Finance and Investor Relations, 650-249-9091 x1471
Laura Zobkiw, Corporate and Media Relations, 650-249-9091 x1649
SOURCE Natera, Inc.