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.
