Largest U.S. Health Plan Now Covers Non-Invasive Prenatal Testing (NIPT) for all Pregnancies
SAN CARLOS, Calif., Dec. 1, 2020 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced that the largest health plan in the United States has extended coverage of NIPT to all pregnancies.
The expanded coverage comes only a few months after the publication of a guideline by the American College of Obstetricians and Gynecologists (ACOG) in collaboration with the Society for Maternal-Fetal Medicine (SMFM), that supports offering aneuploidy screening options, including NIPT, to all patients, regardless of maternal age or baseline risk.1 This medical policy change also follows a number of other recently expanded coverage decisions from top payors, with the vast majority of commercial lives in the United States now covered.
"The average risk NIPT market is significantly underpenetrated, and lack of payor coverage has been the primary barrier for broad adoption," said Paul Billings, MD, Chief Medical Officer at Natera. "Studies have shown that broad adoption of NIPT could result in 98% fewer false positives and 20% fewer false negative results for common aneuploidies, compared to older screening modalities.2,3 Today’s announcement has the potential to have a positive impact on health outcomes for pregnancies in the U.S."
"As the market leader, Natera is in a strong position to capitalize on the significant volume growth opportunity and improved test economics resulting from these policy changes," said Ramesh Hariharan, General Manager of Natera’s Women’s Health business. "We believe we are on track to achieve profitability in our Women’s Health business in 2021."
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 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 or other 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, 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
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1ACOG Practice Bulletin 226: Screening for Fetal Chromosomal Abnormalities. Published August 2020.
2Norton ME, et al. Cell-free DNA analysis for noninvasive examination of trisomy. N Engl J Med. 2015 Apr 23;372(17):1589-97.
3Ryan A, et al. Validation of an Enhanced Version of a Single-Nucleotide Polymorphism-Based Noninvasive Prenatal Test for Detection of Fetal Aneuploidies. Fetal Diagn Ther. 2016;40(3):219-223.
SOURCE Natera, Inc.