SAN CARLOS, Calif., Aug. 22, 2019 /PRNewswire/ -- Natera, Inc. (NTRA), a global leader in cell-free DNA testing, today announced that it has now processed more than two million Panorama® non-invasive prenatal tests (NIPT). Approximately 2,000 Panorama tests are processed each working day, and clinical use continues to increase with more than 20% annual growth in processed units.1
The Panorama test has been extensively validated in 18 peer-reviewed published clinical studies involving more than 170,000 patients. Additionally, Natera has funded the largest prospective NIPT trial ever conducted: the 20,000-patient SNP-based Microdeletion and Aneuploidy Registry Trial (SMART) study. Primary study results are expected in 2020. As the only SNP-based NIPT, Panorama has unique capabilities including the lowest published false negative and false positive rates, the ability to detect triploidy and vanishing twins, and to determine zygosity in twin pregnancies. Natera's focus on quality, reliability, and clinical differentiation have contributed to Panorama's market leadership position in the United States.
"We are deeply grateful to the patients that inspired us, the thought leaders who guided us, and the physicians and partners who have placed their trust in us in this shared mission," said Steve Chapman, Natera's Chief Executive Officer. "We could not have achieved this milestone without the trust of clinicians who have joined us in driving this revolutionary shift in prenatal genetic testing, from traditional serum screening to cell-free DNA testing."
"Non-invasive prenatal testing became available in 2011 to improve fetal care. Previously, pregnant women received high rates of inaccurate screening results concerning the health of their baby," said Paul Billings M.D., Ph.D., Natera's Chief Medical Officer. "Today, many women have access to a highly accurate NIPT which has contributed to a reduction in the number of invasive confirmatory diagnostic procedures and associated complications."
Panorama reveals a baby's risk for severe genetic disorders as early as nine weeks into pregnancy. The test uses a unique single-nucleotide polymorphism (SNP)-based technology to analyze fetal/placental DNA obtained through a blood draw from the mother. It is the only test that differentiates between maternal and fetal DNA in the relevant chromosomes of interest. The test also screens twin pregnancies for zygosity, fetal sex of each baby, and identifies risk for more genetic conditions in twin pregnancies than any other NIPT. Panorama is one of several genetic screening tests from Natera designed to help families on the path to parenthood.
This test was developed by Natera, Inc., a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). This test has 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 a global leader in cell-free DNA testing. The mission of the company is to change the management of disease worldwide with a focus on reproductive health, oncology, and organ transplantation. 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 care for pregnant women, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. Follow Natera on LinkedIn.
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the 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 commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, our collaborations with commercial partners such as medical institutions, contract laboratories, laboratory partners, and other third parties, 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, or 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 "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.
Investor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090
Media: Allison Rogan, 650-468-3250, firstname.lastname@example.org
1. Natera Fiscal Year 2017 and 2018 results.
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