Natera Announces National Commercial Coverage for its Fetal RhD NIPT

Coverage from one of the largest payors in the country expands access to fetal RhD testing for pregnant patients nationwide

AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) and genetic testing, today announced a new policy for commercial coverage of its cfDNA Fetal RhD noninvasive prenatal test (Fetal RhD NIPT) from one of the largest payors in the United States.

Effective as of Jan. 2025, the policy notes that coverage of fetal RhD testing is available when a pregnancy may be at risk for alloimmunization, when paternal antigen typing is unavailable or heterozygous, and if a patient declines amniocentesis or it is not recommended for the pregnancy.

Up to 15 percent of pregnant patients are RhD-negative¹. When the maternal blood type is RhD-negative and the fetal blood type is RhD-positive, antibodies can develop (alloimmunization) that can lead to hemolytic disease of the fetus and newborn.

Natera’s Fetal RhD NIPT can be performed as early as nine weeks gestation and determines fetal RhD status from the blood of a pregnant patient. It is offered through the Company’s women’s health suite of products, which includes Panorama, the no. 1 ordered NIPT in the U.S.

“These new policies expand access to important testing that can prevent unnecessary medical treatment in pregnancies,” said Ramesh Hariharan, PhD, General Manager of Women’s Health at Natera. “Broadening commercial coverage to include fetal RhD testing reinforces the importance of this offering and the benefits it can bring to pregnant patients nationwide.”

About Natera

Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 250 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. For more information, visit www.natera.com.

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 coverage and reimbursement determinations from third-party payers, or our expectations of the benefits of our 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.

References

1. Zipursky A, Paul VK. The global burden of Rh disease. Arch Dis Child Fetal Neonatal Ed 2011;96:F84–5. (Level III)