International Society for Prenatal Diagnosis Recommends cfDNA Screening in Twin Pregnancies
Recommends incorporating zygosity, a capability unique to the Panorama® test, into clinical practice
SAN CARLOS, Calif., Oct. 30, 2020 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA (cfDNA) testing, applauds the recent International Society for Prenatal Diagnosis (ISPD) position statement recommending the use of cfDNA screening in twin pregnancies. The position statement can be found here.
The ISPD position statement endorses cfDNA screening for autosomal trisomies in twin pregnancies and recommends that laboratories incorporate zygosity into the interpretation of non-invasive prenatal testing (NIPT) results. The statement also highlights the ability of SNP-based NIPT to determine zygosity and individual fetal fractions in dizygotic pregnancies.1
"ISPD has now echoed the ACOG-SMFM position recognizing the clinical value of NIPT for twin pregnancies, citing high sensitivity and positive predictive values," said Herman Hedriana, MD, MFM, Professor of Clinical Obstetrics and Gynecology and Director, Maternal-Fetal Medicine at UC Davis Health. "Both sets of recommendations highlight the utility of zygosity, an attribute unique to Natera’s Panorama test, which can inform triaging of high-risk twin pregnancies to specialists."
"Given the Panorama test’s unique ability to determine zygosity and individual fetal fraction in dizygotic pregnancies, these guidelines provide a good opportunity for us to expand our market leadership in NIPT," said Ramesh Hariharan, General Manager for Natera’s Women’s Health business."
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 and 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. Natera has published 23 papers, studying over 1.3 million patients, since the launch of Panorama – the largest body of evidence in the space today.
Panorama has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.
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 women’s health, oncology, and organ health. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif. It offers proprietary genetic testing services to inform obstetricians, 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 the effects, if any, of statements issued by professional societies, our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for 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, or coverage and reimbursement determinations from third-party 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., 510-826-2350
Media: Paul Greenland, VP of Corporate Marketing, Natera, Inc., firstname.lastname@example.org
1. Palomaki GE, et al. International Society for Prenatal Diagnosis (ISPD) Position Statement: Cell free (cf)DNA screening for Down syndrome in multiple pregnancies. Prenat. Diagn. October 5, 2020. doi: 10.1002/pd.5832.
SOURCE Natera, Inc.