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
Natera’s study is the largest clinical validation of a fetal RhD test performed in
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
“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
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20241202602532/en/
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
Source: Natera, Inc.
