Fourth largest health plan adopts average risk coverage post-ACOG and SMFM guideline change
SAN CARLOS, Calif., Oct. 8, 2020 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced that Centene, a major healthcare insurance company, has extended coverage of the Panorama non-invasive prenatal test (NIPT) to all pregnant women, including twin pregnancies, representing 24 million additional covered lives.
The expanded coverage follows the recent joint guideline released by the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) that supported offering aneuploidy screening options, including NIPT, to all patients, regardless of maternal age or baseline risk. The guideline concluded that NIPT is the most sensitive and specific screening test available for common fetal aneuploidies, and for the first time, endorsed NIPT use in twin pregnancies.
"I am extremely pleased to see that coverage for cell-free DNA screening, which has already been recommended by ACOG for all pregnant women, will now be extended to Medicaid populations," said Larry Platt, MD, MFM, Clinical Professor in the Department of Obstetrics and Gynecology at the David Geffen School of Medicine at UCLA. "Broadening coverage to this population is an overdue effort to help resolve established and systemic disparities and inequities in women’s healthcare."
"The average risk NIPT market is significantly underpenetrated today. We believe expanded insurance coverage and the recent society guideline will enable access for more women, unlocking significant volume growth," 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 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.
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SOURCE Natera, Inc.