Coverage for Natera's Panorama® Prenatal Test Extended by Greater Than 20 Million Lives
SAN CARLOS, Calif., April 6, 2020 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing and non-invasive prenatal testing (NIPT) today announced an expansion in coverage of its Panorama test to all pregnant women, regardless of age, after a major national insurance company expanded coverage of NIPT temporarily.
Recently, the Society for Maternal-Fetal Medicine’s practice suggestions1 and a publication in the American Journal of Obstetrics & Gynecology MFM2 discussed ways to reduce prenatal office visits during COVID-19. The suggestions included expanding the use of NIPT, which can be accessed through Natera without a live office visit.
"This expansion will allow more expectant mothers, their families, and providers to access best in class care," said Paul Billings, M.D., Ph.D., Natera’s CMO and SVP of Medical Affairs. "During this pandemic, Natera continues to offer a suite of remote services including genetic information sessions with board-certified genetic counselors and access to our extensive mobile blood drawing network, allowing prenatal care to be delivered safely in a patient’s home."
Expanded NIPT coverage quickens Natera’s path to profitability for its reproductive health business. "Today’s announcement extends coverage during this time to roughly one-third of the remaining uncovered average risk patients who have private insurance," said Mike Brophy, Natera’s CFO.
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. Panorama results have been published in over 25 peer reviewed papers covering roughly 1 million patients.
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 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 coverage and reimbursement determinations from third-party payers and any resulting effects on our results of operations, 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. 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
Media: Paul Greenland, VP of Corporate Marketing, firstname.lastname@example.org
- The Society for Maternal-Fetal Medicine COVID-19 Ultrasound Practice Suggestions. Society for Maternal-Fetal Medicine; March 24, 2020.
- MFM Guidance for COVID-19. American Journal of Obstetrics & Gynecology MFM; March 19, 2020.
SOURCE Natera, Inc.