Study Shows High Positive Predictive Values in Detecting Common Chromosomal Aneuploidies in All Women, Including Women Under 35 Years of Age
SAN CARLOS, Calif., Feb. 19, 2019 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, presented data at the Society for Maternal-Fetal Medicine (SMFM) Annual Pregnancy Meeting showing strong clinical performance of its Panorama® SNP-based non-invasive prenatal test (NIPT) to detect common chromosomal aneuploidies (genetic abnormalities) in all women, including women under 35 years of age, with high accuracy.1
The primary objective of the study was to prospectively analyze the clinical performance of the company’s NIPT as a part of its rigorous laboratory-based quality assurance program. Fetal outcome data was solicited from women who received a high-risk result from over 900,000 Panorama tests performed between 2013 and 2017. The positive predictive value (PPV) in this cohort was 95.2% for trisomy 21 (Down syndrome), 93.5% for trisomy 18 (Edwards syndrome), 77.9% for trisomy 13 (Patau syndrome), and 86.7% for monosomy X. The PPV was similar for both high-risk (maternal age ≥ 35 yrs) and average risk (< 35 yrs) pregnancies, consistent with a previous study (n=17,885).2
"The high positive predictive values demonstrated in this study once again validate the utility of NIPT as a primary prenatal screening tool in the management of all pregnancies, including women under 35 years of age," said Dr. Kimberly A. Martin, Natera Vice President, Global Women’s Health. "We believe this study continues to reaffirm NIPT as the most accurate screening option for pregnant women of all ages."
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. 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, researchers in cancer including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. Follow Natera on LinkedIn and Twitter.
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, 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, 650-249-9090
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1DiNonno W, Norvez A, Parmar S, et al. High-Risk Case Results from a Quality Assurance (QA) Program Monitoring Single-Nucleotide Polymorphism (SNP)-Based NIPT Performance. Poster presented at: Society for Maternal-Fetal Medicine Annual Pregnancy Meeting; February 16, 2019; Las Vegas, NV, Poster #929.
2Dar P, Curnow KJ, Gross SJ, et al. Clinical experience and follow-up with large scale single-nucleotide polymorphism-based noninvasive prenatal aneuploidy testing. Am J Obstet Gynecol 2014;211:527.e1-17.
SOURCE Natera, Inc.