NIPT for Average Risk Now Covered for 139 Million Commercial Lives

Rhea-AI Summary

Natera, Inc. (NASDAQ: NTRA) announces the extension of non-invasive prenatal testing (NIPT) coverage for all singleton pregnancies by a major health plan, adding 17 million covered lives. This extends the total to 139 million commercial lives, representing approximately 77% of total lives covered for average risk NIPT in the U.S. This expansion aligns with new ACOG guidelines supporting NIPT, aiming to unlock volume growth in a currently underpenetrated market. Natera emphasizes its Panorama® test's advanced SNP-based technology and its extensive clinical evidence to support this growth.

Positive

• Extended NIPT coverage to 17 million additional lives, increasing total to 139 million.
• Potential for significant growth in the average risk NIPT market due to ACOG guideline changes.
• Panorama test's unique SNP-based technology offers competitive advantages and supports market dominance.

Negative

• None.

SAN CARLOS, Calif., Oct. 29, 2020 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced that a major health plan has extended coverage for non-invasive prenatal testing (NIPT) to all singleton pregnancies,¹ representing 17 million additional covered lives. This is the latest in a string of medical policy changes in 2020 that have more than doubled the number of covered lives for average risk NIPT. Natera estimates that there are currently 139 million commercial lives covered in the U.S. for average risk NIPT, representing about 77% of covered lives.

The expanded coverage follows the recent guideline published 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.² 

"The average risk NIPT market still remains highly underpenetrated; increased insurance coverage, as well as improved society guidelines, are the key drivers for unlocking volume growth and improving test economics," said Ramesh Hariharan, General Manager for Natera's Women's Health business. "The publication of the recent guidelines^2,3 underscores the Panorama^® test's unique SNP-based clinical advantages, putting us in a very strong position to capitalize on the opportunity."

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. Humana Noninvasive Prenatal Screening Medical Coverage Policy Number HCS-0430-025. Effective October 22, 2020.
2. ACOG Practice Bulletin Number 226: Screening for Fetal Chromosomal Abnormalities. Published August 2020.
3. Palomaki GE, et al. International Society for Prenatal Diagnosis (ISPD) Position Statement: Cell free (cf)DNA screening for Down syndrome in multiple pregnancies. Prenat. Diagn. October 5, 2020. doi: 10.1002/pd.5832. 

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SOURCE Natera, Inc.

FAQ

What is the significance of Natera's recent NIPT coverage expansion for NTRA?

The expansion adds 17 million covered lives for non-invasive prenatal testing, increasing total coverage to 139 million commercial lives, representing about 77% of the market.

When did the new NIPT coverage become effective for NTRA?

The coverage extension became effective on October 22, 2020.

How does the ACOG guideline change impact Natera (NTRA)?

The ACOG guidelines support NIPT for all patients, potentially increasing test adoption and market penetration.

What competitive advantages does Panorama offer according to Natera (NTRA)?

Panorama uses a SNP-based technology to differentiate maternal and fetal DNA and is the only test that provides comprehensive risk assessments for both singleton and twin pregnancies.