Study Shows Natera's Spectrum Preimplantation Genetic Testing for Aneuploidy Improves IVF Outcomes for All Women, Regardless of Maternal Age
SAN CARLOS, Calif., Aug. 2, 2018 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a leader in non-invasive genetic testing, today announced the publication of a study demonstrating the value of the company's Spectrum® preimplantation genetic screening for aneuploidy (PGT-A) to improve in vitro fertilization (IVF) results for all women, including those of advanced maternal age.
The study, published in Fertility and Sterility, retrospectively analyzed pregnancy outcomes from more than 1,800 IVF cycles performed at two fertility centers using Spectrum, a single-nucleotide polymorphism (SNP)-based PGT-A technology.1 Spectrum screens all 24 chromosomes to provide comprehensive embryo aneuploidy results. Aneuploidy, an abnormal number of chromosomes, is common in human embryos—particularly as women age—and is the primary cause of failed IVF.2
Study results demonstrated that Spectrum PGT-A use during IVF led to excellent implantation (70 percent), clinical pregnancy (71 percent), and live birth (65 percent) rates. Currently in the U.S., less than half of all in vitro transferred embryos implant and lead to pregnancy.3,4 These rates were achieved primarily with single embryo transfer (SET), substantiating routine use of SET with SNP-based PGT-A. In addition, with the use of PGT-A, pregnancy implantation rates remained high even in older women, supporting the use of PGT-A to improve implantation rates in women of advanced maternal age.3,4
"This study shows that Spectrum PGT-A can help mitigate the negative effects of maternal age on IVF outcomes by allowing selective transfer of embryos that are more likely to lead to sustained implantation," said Kimberly Martin, M.D., Natera's senior global medical director, women's health. "These findings also demonstrate that successful IVF can be achieved without multiple-embryo transfer when combined with PGT-A. Increased use of single embryo transfer should reduce the incidence of multiple pregnancies, which are associated with higher pregnancy complication rates, in addition to financial and psychosocial challenges for families.
Spectrum preimplantation genetic testing evaluates the number of chromosomes in embryos to detect extra or missing chromosomes and screens for inherited genetic disorders. Spectrum's patented SNP-based technology with Parental Support provides a highly comprehensive 24-chromosome PGT-A with an accuracy greater than 99 percent per chromosome call, helping provide the best chance of transferring an embryo with the correct number of chromosomes. Identifying the healthiest embryos for transfer improves the chance of a successful pregnancy while reducing the chance of miscarriage or of having a child with a chromosome condition. Spectrum is part of Natera's portfolio of genetic diagnostic and screening tests 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 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 and organ transplantation 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.
Contacts Investor Relations: Mike Brophy, CFO, Natera, 650-249-9090 Media: Barbara Sullivan, Sullivan & Associates, 714-374-6174, firstname.lastname@example.org
Simon AL, Kiehl M, Fischer E, et al. Pregnancy outcomes from more than 1,800 in vitro fertilization cycles with the use of 24-chromosome single-nucleotide polymorphism-based preimplantation genetic testing for aneuploidy. Fertil Steril. 2018;110:113-121.
Hodes-Wertz B, Grifo J, Ghadir S, et al. Idiopathic recurrent miscarriage is caused mostly by aneuploid embryos. Fertil Steril. 2012;98:675–680.
2015 Assisted Reproductive Technology National Summary Report. Centers for Disease Control and Prevention, American Society for Reproductive Medicine, Society for Assisted Reproductive Technology. 2017.
Toner JP, Coddington CC, Doody K, et al. Society for assisted reproductive technology and assisted reproductive technology in the United States: a 2016 update. Fertil Steril. 2016;106(3):541–546.