First published evidence showing that individual fetal fraction measurement is a critical determinant of test reliability
SAN CARLOS, Calif., Nov. 27, 2019 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced results of a study published in the Journal of Prenatal Diagnosis which demonstrated that measuring individual fetal fractions combined with reporting zygosity provides clinically powerful insights into the accuracy of the aneuploidy results.1 Panorama® remains the only non-invasive prenatal test (NIPT) that reports zygosity for twins, and individual fetal fractions for dizygotic pregnancies.2
The study examined Panorama results from a cohort of 126,061 pregnancies, of which 3.7% were twin pregnancies. The study represents the first published evidence that DNA contribution from each twin in dizygotic pregnancies can vary widely. When the fetal fractions are discrepant, the signal from the dominant twin obfuscates the signal from the other twin. Consequently, NIPTs that only provide a combined fetal fraction and do not assess individual fetal fraction in dizygotic twin pregnancies may not detect a condition in the non-dominant twin, and can increase the risk of false negatives.
"The ability to accurately determine zygosity in twin pregnancies, and individual fetal fraction in dizygotic pregnancies, is a major advancement in the management of twin pregnancies," said Paul Billings, M.D., Ph.D., Natera’s Chief Medical Officer. "NIPTs that do not report both zygosity and individual fetal fraction may be less reliable in assessing the risk of aneuploidies in certain twins."
"Panorama’s SNP technology has unique advantages, including our twins assessment, that are unmatched by other methods. Although twin pregnancies comprise approximately 3-4% of all pregnancies, this new finding is clinically significant and may help us serve new physicians in offices where we do not have a presence today," said Steve Chapman, Natera’s Chief Executive Officer. "We are proud of our accomplishment of reaching 20 publications on Panorama covering a total of more than 1.2 million patients. We believe that the combination of our highly differentiated assay and market-leading portfolio of data is contributing to our continued strong growth."
The study, titled "Cell-free DNA fetal fraction in twin gestations in single-nucleotide polymorphism-based noninvasive prenatal screening" can be found here.
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 commercially available test that differentiates between maternal and fetal DNA to assess the risk of aneuploidies. 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, transplant physicians, 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, 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
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1Hedriana H, et al. Cell-free DNA fetal fraction in twin gestations in single-nucleotide polymorphisms-based noninvasive prenatal screening. Prenat Diagn. 2019. doi: 10.1002/pd.5609.
2Norwitz ER, et al. Validation of a Single-Nucleotide Polymorphism-Based Non-Invasive Prenatal Test in Twin Gestations: Determination of Zygosity, Individual Fetal Sex, and Fetal Aneuploidy. J Clin Med. 2019;8(7). pii: E937.
SOURCE Natera, Inc.