Clinical Validation Study on Natera's Fetal RhD NIPT Published in Obstetrics & Gynecology
Test demonstrated high performance metrics in largest study of its kind in the US with sensitivity of 100% and specificity of 99.3%
Natera, Inc. (NASDAQ:NTRA), a global leader in cell-free DNA and genetic testing, today announced that Obstetrics & Gynecology (also known as The Green Journal) published the Company's clinical validation study on its cell-free DNA (cfDNA) Fetal RhD noninvasive prenatal test (Fetal RhD NIPT).
Natera's study is the largest clinical validation of a fetal RhD test performed in the United States to date, with fetal RhD status confirmed via newborn serology in 655 RhD-negative pregnant patients. The study provides compelling scientific evidence on the ability of Natera's Fetal RhD NIPT to identify fetal RhD status, and demonstrates its potential to assist patients and clinicians in the prevention and management of RhD alloimmunization. In addition, Natera's next generation sequencing (NGS)-based Fetal RhD test can identify RHD pseudogene and other hybrid variants that are more commonly occurring in people of non-European ancestries.
Key highlights of the study include:
- 356/356 fetuses were correctly identified as fetal RhD positive (sensitivity: 100% [95% CI: 98.9-100.0]).
- Of the 297 RhD-negative fetuses, 295 were correctly identified as RhD-negative (specificity of 99.3% [95% CI: 97.6-99.8]).
- Positive predictive value for the test was 99.4% and negative predictive value was >99.9%.
- The study included a representative mix of race and ethnicities in the RhD-negative U.S. population.
RhD alloimmunization, which can lead to hemolytic disease of the fetus and newborn, can occur when an RhD-negative patient carries an RhD-positive fetus. Historically, this risk is well managed by giving Rho(D) immune globulin therapy (RhIg). However, approximately 40% of patients with an RhD-negative fetus receive this medication unnecessarily. This is particularly important as recent nationwide shortages of RhIg have created an even greater need for testing that allows providers to both prevent alloimmunization and conserve supplies of RhIg, consistent with recent guidance from the American College of Obstetricians and Gynecologists (ACOG) supporting cfDNA screening for fetal RhD testing.
"This large clinical validation study demonstrated excellent performance in identification of fetal RhD status," said Marisa Gilstrop Thompson, M.D., a board-certified physician in Maternal Fetal Medicine, Obstetrics and Gynecology, and Clinical Genetics with the Delaware Center for Maternal and Fetal Medicine of Christiana Care. "Access to highly accurate fetal RhD testing has the potential to transform the care of RhD-negative pregnant patients."
"Supporting reproductive health has long been part of Natera's mission, and we are proud to offer this noninvasive, highly accurate cfDNA test to help clinicians prevent potential complications in future pregnancies," said Sheetal Parmar, MS CGC, Natera's senior vice president of medical affairs for women's health.
The RhD test is an 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 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.
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