Backed by large clinical validation study with over 650 RhD-negative patients with confirmed outcomes, resulting in 100% sensitivity and >99% specificity
AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) and genetic testing, today announced the launch of a new cfDNA-based fetal RhD test. This comes at a critical time for the healthcare industry, helping physicians navigate patient care given nationwide shortages of Rho(D) immune globulin therapy (RhIg).
Natera's test can be performed as early as nine weeks gestation and determines fetal RhD status from the blood of a pregnant patient, including complex pseudogene and RhD-CE-D hybrid variants. The vast majority of other NIPT laboratories do not offer fetal RhD assessment, which makes it a key differentiator in addition to Natera's core SNP-based technology.
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. Historically, this risk is well managed by giving RhIg to all RhD-negative patients despite the fact that only 60%2 of them carry an RhD-positive fetus. In response to the nationwide shortage of RhIg, the American College of Obstetricians and Gynecologists (ACOG) recently stated that using NIPT to "prioritize use of RhIg and conserve RhIg supply is a reasonable consideration."
The product launch is backed by a validation study that included fetal RhD status confirmed via newborn serology in more than 650 RhD-negative pregnancies. This is roughly 10 times more patients with confirmed outcomes than validation studies from other laboratories. Natera's test performed with 100% sensitivity and greater than 99% specificity.
Natera's study was accepted as a late-breaking abstract for ACOG's Annual Clinical & Scientific Meeting, and the results will be presented at the meeting on May 18, 2024. This clinical validation is Natera's second study on fetal RhD. In 2023, Natera presented data at the American Society of Human Genetics (ASHG) Annual Meeting on 180 RhD-negative pregnancies, which showed similar performance.
"Having an accurate, well-validated fetal RhD test is critical given the current shortage of RhIg and the tremendous complications alloimmunization can cause to a baby's health in a subsequent pregnancy," said Victor Klein, M.D., M.B.A., System Director of Quality & Patient Safety for Obstetrics & Gynecology at Northwell Health. "It is especially important that clinicians have access to these tools right now to help determine which patients are most in need of RhIg."
"We are proud to offer this highly validated fetal RhD test at a time of critical need in the prenatal community," said Jeffrey Meltzer, M.D., Senior Medical Director, Women's Health at Natera.
The RhD test is a new offering within Natera's women's health suite of products, which also includes Panorama, the No. 1 ordered noninvasive prenatal test in the U.S.
About Panorama
Panorama screens 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 maternal blood draw. It is the only commercially available NIPT that differentiates between maternal and fetal DNA to assess the risk of aneuploidies. Panorama has been the subject of more than 40 peer-reviewed publications of over 2 million patients. 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 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 200 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 .
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 whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, 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 and www.sec.gov.
References
- Zipursky A, Paul VK. The global burden of Rh disease. Arch Dis Child Fetal Neonatal Ed 2011;96:F84–5. (Level III)
- ACOG. Practice Bulletin 181: Prevention of Rh D Alloimmunization. 2017.
Contacts
Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350, investor@natera.com
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com