First NIPT to Determine Zygosity for Twins as Early as Nine Weeks' Gestation
SAN CARLOS, Calif., Oct. 2, 2017 /PRNewswire/ — Natera (NASDAQ: NTRA), a leader in non-invasive genetic testing and the analysis of circulating cell-free DNA, today announced that the company’s Panorama® non-invasive prenatal test (NIPT) is now validated to screen twin pregnancies for zygosity (identical or non-identical/fraternal) and chromosomal abnormalities.
Natera’s Panorama® is the first NIPT that can determine whether twins are monozygotic (identical) or dizygotic (non-identical or fraternal) as early as nine weeks’ gestation.1 Accurately assessing zygosity early in twin pregnancies is important; Panorama identified monozygotic twins with >99% sensitivity and specificity in validation studies.1 Monozygotic pregnancies can be at risk for complications that come from monochorionicity (a shared placenta). About 67% of monozygotic pregnancies are monochorionic pregnancies, which are at the highest risk for intrauterine growth restriction, birth defects, and twin-twin transfusion syndrome (TTTS)—a complication of disproportionate blood supply resulting in high morbidity and mortality.2-7
Until now, expecting parents and their physicians may have faced unanswered questions in the beginning of a twin pregnancy. Chorionicity can sometimes be difficult to determine, especially as a pregnancy approaches the second trimester. In fact, studies have shown that up to 19% of monochorionic pregnancies are incorrectly classified as dichorionic and may not be managed appropriately.4
"Panorama now fills a significant unmet need for expecting parents and physicians managing twin pregnancies," said Matthew Rabinowitz, Ph.D., CEO and founder of Natera. "Enhancing Panorama to include screening for twin pregnancies is an important advancement that can determine zygosity at an early stage and help clinicians identify higher risk for conditions that affect more than 1 in 45 twin pregnancies. This new capability builds on the success of Panorama, the market-leading NIPT for common chromosomal conditions."
Panorama builds on its history as the only NIPT that can tell the difference between the mother’s and the baby’s DNA, becoming the only NIPT that can now distinguish between each twin’s DNA. This unique technology enables Panorama to determine zygosity and the gender of each twin. It also helps identify risk for more genetic conditions in twin pregnancies than other NIPTs, including monosomy X, sex chromosome trisomies, and 22q11.2 deletion syndrome.*
Natera is a global leader in cell-free DNA testing. The mission of the company is to transform the diagnosis and management of genetic diseases. 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 Twitter, Facebook, and 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.
*Available for monozygotic twins only
1Natera validation data. Manuscript in preparation
2Society for Maternal-Fetal Medicine, Clinical guideline: Twin-twin transfusion syndrome, Jan 2013.
3American College of Obstetricians and Gynecologists and Society for Maternal-Fetal Medicine, Practice Bulletin No. 169, Oct 2016.
4Blumenfeld et al. J Ultrasound in Med. 2014 Dec;33(12):2187-92.
5Oldenburg et al. Ultrasound Obstet Gynecol 2012; 39: 69–74.
6Chasen, Chervenak. Twin pregnancy: Prenatal issues. In: UpToDate, Post, CL, DL (Ed), UpToDate, Aug 2017.
7Cunningham et al. Williams Obstetrics. 24th edition. New York: McGraw-Hill Education, 2014.
Mike Brophy, CFO, Natera, Inc., 650-249-9091 x 1471, email@example.com
Barbara Sullivan, Sullivan & Associates, 714-374-6174, firstname.lastname@example.org
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.
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