Second Largest Commercial Insurer Covers Non-Invasive Prenatal Testing for All Pregnancies

Rhea-AI Summary

Natera, Inc. (NASDAQ: NTRA) announced that the second-largest commercial health plan in the U.S. has expanded coverage for non-invasive prenatal testing (NIPT) to all singleton pregnancies. This follows recent coverage expansions by other major health plans, resulting in over 90% of commercially-covered lives now having average-risk NIPT coverage. Natera's unique SNP-based NIPT technology aims to enhance prenatal care and reduce false negatives and positives, significantly impacting health outcomes. The company's Panorama test is a leading NIPT, backed by extensive clinical evidence.

Positive

• Expansion of NIPT coverage to all singleton pregnancies increases market access.
• Over 90% of commercially-covered lives now have average-risk NIPT coverage, boosting potential revenues.
• Panorama test utilizes advanced SNP-based technology, providing a competitive edge in prenatal care.

Negative

• None.

SAN CARLOS, Calif., Dec. 3, 2020 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced that the second largest commercial health plan in the United States has extended coverage of non-invasive prenatal tests (NIPT) to all singleton pregnancies. This announcement comes on the heels of the largest U.S. health plan's expansion earlier this week. Natera now estimates that over 90% of all commercially-covered lives will have average risk NIPT coverage.

These expansions follow the publication of a revised 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 

"The decrease in false negatives and false positives when switching from older screening modalities to NIPT is dramatic. Increased access to these more accurate tests should translate to a meaningful impact on health outcomes for more pregnancies," said Herman Hedriana, MD, MFM, Professor of Clinical Obstetrics and Gynecology and Director, Maternal-Fetal Medicine at UC Davis Health. 

"With the decisions made this week, all 20 of the largest commercial payors now cover NIPT, independent of prior risk," said Ramesh Hariharan, General Manager of Natera's Women's Health business. "With our unique SNP-based NIPT, we will have an even greater opportunity to make a positive impact on prenatal care."

About Panorama^®

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.

About Natera

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.

Forward-Looking Statements

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.

Contacts

Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350

Media: Paul Greenland, VP of Corporate Marketing, Natera, Inc., pr@natera.com

References

1. ACOG Practice Bulletin 226: Screening for Fetal Chromosomal Abnormalities. Published August 2020.

 

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SOURCE Natera, Inc.

FAQ

What recent coverage changes has Natera experienced regarding NIPT?

Natera announced that the second-largest commercial health plan in the U.S. extended NIPT coverage to all singleton pregnancies.

How much of the market does Natera estimate to have NIPT coverage?

Natera estimates that over 90% of all commercially-covered lives will have average risk NIPT coverage.

What is the significance of the ACOG guideline for Natera?

The ACOG guideline supports offering NIPT to all patients, which can lead to increased demand for Natera's testing services.

What technological advantage does Natera's Panorama test offer?

Natera's Panorama test uses a unique SNP-based technology to differentiate between maternal and fetal DNA, enhancing the accuracy of results.

What is the stock symbol for Natera?

Natera is traded under the stock symbol NTRA.